Borderline Pulmonary Hypertension Patients Often Progress To Overt Disease

MedicalResearch.com Interview with:

Dr. Evan L. Brittain, MD Assistant Professor of Medicine Vanderbilt University School of Medicine

Dr. Brittain

Dr. Evan L. Brittain, MD
Assistant Professor of Medicine
Vanderbilt University School of Medicine

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The purpose of this study was to determine whether pulmonary pressure values below the diagnostic threshold for pulmonary hypertension (25mmHg) are associated with an increased risk of mortality. We studied over 4,000 consecutive individuals referred for right heart catheterization, the “gold-standard” procedure for measuring pulmonary pressure. We found that borderline levels of mean pulmonary pressure (19-24mmHg) were common, representing 18% of all patients referred for this procedure. Borderline mean pulmonary pressure values were also associated with 31% increase in mortality after accounting for many other clinical factors. Finally, we found that most of the patients with borderline pulmonary hypertension who underwent repeat catheterization often progressed to overt pulmonary hypertension.

This study suggests that patients with borderline pulmonary hypertension should be considered an at-risk group.

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IPF: Combination of Nintedanib and Pirfenidone May Have Added Benefit With Manageable Side Effects

MedicalResearch.com Interview with:

Professor Carlo Vancheri Professor of Respiratory Medicine, University of Catania, Italy and Director of the Regional Referral Centre for Rare Lung Diseases and the Laboratory of Experimental Respiratory Medicine.

Prof. Vancheri

Professor Carlo Vancheri
Professor of Respiratory Medicine,
University of Catania, Italy and Director of the Regional Referral Centre for Rare Lung Diseases and the Laboratory of Experimental Respiratory Medicine.

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: The aim of Boehringer Ingelheim’s INJOURNEY trial was to investigate the safety profile of Ofev (nintedanib) in combination with pirfenidone in treating patients with idiopathic pulmonary fibrosis (IPF). Nintedanib and pirfenidone, the only two FDA-approved drugs for the treatment of IPF, are able to slow down the progression of the disease, reducing the forced vital capacity (FVC) decline of about 50%, but this is not a cure. The target for the future is to have even more effective treatments. In the meanwhile, it is necessary to optimize the use of the available drugs. The medical treatment of other pulmonary diseases such as COPD, asthma or pulmonary hypertension is already based on different combinations of drugs.

This 12-week, open-label, randomized study was designed to evaluate the safety, tolerability and pharmacokinetics of nintedanib with add-on pirfenidone, compared with nintedanib alone in patients with IPF. Change in FVC, the established efficacy endpoint in IPF trials, was evaluated as an exploratory endpoint.

The primary endpoint of the INJOURNEY trial was the percentage of patients with on-treatment gastrointestinal adverse events from baseline to week 12 of randomized treatment, and the results showed that the combination of nintedanib and add-on pirfenidone resulted in a manageable safety and tolerability profile, similar to the profile of each drug individually in the majority of patients. Results also indicated there may be a slower decline in FVC in patients treated with pirfenidone along with nintedanib compared with nintedanib alone, suggesting a potential benefit of the combination. However, further research will be necessary to fully evaluate the efficacy of the combination.

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Pneumococcal Vaccine Rates Still Too Low Among Adults With Work-Related Asthma

MedicalResearch.com Interview with:

Katelynn Dodd MPH Respiratory Health Division National Institute for Occupational Safety and Health Centers for Disease Control and Prevention Morgantown WV 26505

Katelynn Dodd

Katelynn Dodd MPH
Respiratory Health Division
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
Morgantown WV 26505

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Adults with asthma are at increased risk for pneumococcal infection. Adults with asthma who get pneumococcal pneumonia are at risk for additional complications including asthma exacerbation and invasive pneumococcal disease. Our results indicated that adults with work-related asthma were more likely to have received a pneumococcal vaccine than adults with non-work-related asthma—54 percent compared to 35 percent respectively; however, pneumococcal vaccination coverage among all adults with asthma, work-related or not, who have ever been employed in this study falls short of achieving the coverage public health experts recommend. Among adults with work-related asthma, pneumococcal vaccine coverage was lowest among Hispanics (36 percent), those without health insurance (39 percent), and adults aged 18 to 44 years (42 percent).

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Large Trial Evaluates Inhaled Nitric oxide on Survival Without Pulmonary Dysplasia in Preterm Infants

MedicalResearch.com Interview with:

Shabih U. Hasan, MD, DCH, FRCPC Professor and Staff Neonatologist, Alberta Health Services Department of Pediatrics, Cumming School of Medicine University of Calgary

Dr. Hasan

Shabih U. Hasan, MD, DCH, FRCPC
Professor and Staff Neonatologist, Alberta Health Services
Department of Pediatrics, Cumming School of Medicine
University of Calgary

MedicalResearch.com: What is the background for this study?

Response: Approximately 8% of all infants are born prematurely (preterm birth <37 weeks postmenstrual age). Preterm infants have many challenges including establishment of adequate pulmonary gas exchange. Due to not yet fully developed lungs, preterm infants require respiratory support consisting of respirators and other forms of non-invasive ventilation modalities and supplemental oxygen.  Bronchopulmonary dysplasia (BPD) is the commonest morbidity among very low birth weight infants as 40% of survivors at postmenstrual age <30 weeks develop BPD. This is a serious condition as it can lead to short- and long-term pulmonary complications, increased hospital visits and neurodevelopmental impairment. BPD is defined where preterm infants require respiratory support and/or supplemental oxygen at 36 weeks postmenstrual age.

A number of therapeutic and non-therapeutic modalities have been used to prevent BPD including inhaled nitric oxide (iNO).  In 2006, the NO CLD trial demonstrated that iNO prevented BPD (Relative benefit 1.81; CI 1.27-2.59, P = 0.006) if used according to the NO CLD Protocol (Ballard et al., New England Journal of Medicine, 355:343-353, 2006). Our study (NEWNO; Newborns treated with Nitric Oxide) was designed to replicate the NO CLD study.
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Tiotropium (Spiriva) Found Beneficial In Early Stages of COPD

MedicalResearch.com Interview with:
Dr Prof Nanshan Zhong
, MD (Edin), FRCS (Edin), FRCP and
Pixin Ran PhD

National Center for Respiratory Diseases, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Diseases, the First Affiliated Hospital

MedicalResearch.com: What is the background for this study? What are the main findings?

Response:    According to the latest research, in 2015, 3.2 million people died from COPD globally, with an increase of 11.6% in mortality compared with that in 1990 (GBD 2015 Chronic Respiratory Disease Collaborators. Lancet Respir Med. 2017,5:691-706). COPD has now become the third leading cause of death worldwide and is estimated to become the disease with the seventh greatest burden worldwide in 2030. In China, the prevalence was 8.2% among people aged 40 years or greater, according to our epidemiological survey in 2007.

Importantly, current international guidelines have been mainly focusing on the management of moderate-to-severe COPD. However, among this patient cohort, the severely impaired lung function can only be reversed to a very limited extent despite the most potent treatment combinations. Patients with more advanced COPD are frequently associated with a significantly higher mortality and incidence of re-hospitalization and disability, which cause tremendous economic burden for both the families and the society. However, more than 70% of COPD patients are currently categorized as having stage I to early stage II COPD, most of whom have no or very few respiratory symptoms (Zhong NS, et al. Am J Respir Crit Care Med. 2007, 176:753-760; Mapel DW, et al. Int J COPD 2011; 6: 573−581). The vast majority of these patients would have the “COPD assessment Test” (CAT) score of 10 or lower (range: 0 to 40, with higher scores indicating more severe COPD). Admittedly, no medication has been recommended for this patient cohort according to the latest international guidelines. In real-world practice, these patients are almost neglected by physicians and have received virtually no medication. Nonetheless, the annual lung function decline rates among these patients are the most rapid among all COPD patients. (Bhatt SP, et al. Am J Respir Crit Care Med 2015; 191: A2433). An important clinical question has been raised regarding whether an intervention strategy targeting at early stages of COPD can possibly make the airflow limitation more reversible or prevent from further deterioration.

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IPF Patients Treated With Nintedanib (Ofev) More Likely To Have Stable Lung Function

MedicalResearch.com Interview with:

Kevin R. Flaherty

Dr. Flaherty

Kevin R. Flaherty, M.D., M.S.
Professor, Department of Internal Medicine
Associate Director, T32 Multidisciplinary Training Program in Lung Diseases
Chair, Pulmonary Fibrosis Foundation Clinical Care Network Steering Committee
University of Michigan Medicine 

MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This is a new post-hoc analysis, recently presented at the 2017 American Thoracic Society (ATS) conference, which sought to further assess the efficacy of Ofev (nintedanib), an FDA-approved drug treatment for idiopathic pulmonary fibrosis (IPF), and its effect on lung function in those with this disease.

IPF is a rare and serious lung disease that causes permanent scarring of the lungs and affects as many as 132,000 Americans.

The analysis examined pooled data from the two placebo-controlled, global Phase III INPULSIS trials, which evaluated the efficacy and safety of 52 weeks’ treatment with nintedanib in people with IPF. In both trials, a higher proportion of people treated with placebo than nintedanib had disease progression from baseline to week 52, as defined by the proportions of patients with ≥5% or ≥10% declines in lung function, as measured by forced vital capacity (FVC) % predicted. Additionally, a lower proportion of patients treated with placebo than nintedanib had no decline or an improvement in FVC % predicted.

These data support the initial findings from the Phase III INPULSIS trials which found that more patients treated with nintedanib versus placebo had an absolute decline in FVC of less than 5%.

In this subgroup analysis, we assessed the proportions of patients from the two INPULSIS trials treated with nintedanib and placebo who had no decline or an improvement in lung function from baseline to week 52 using pooled data for this post-hoc analysis. In terms of those who participated, a total of 864 patients were included (519 treated with nintedanib, 345 treated with placebo). Baseline characteristics including age, gender and FVC were similar between the subgroups of patients who had no decline or an improvement in FVC and those whose FVC declined, and between the nintedanib and placebo groups within each subgroup.

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Vascular Biomarker Predicts Death or Pulmonary Morbidity in Premature Infants

MedicalResearch.com Interview with:

Jegen Kandasamy MD Division of Neonatology Assistant Professor/Director, Rare Disease Program and Congenital Anomalies Program University of Alabama at Birmingham Birmingham, Alabama

Dr. Kandasamy

Jegen Kandasamy MD
Division of Neonatology
Assistant Professor/Director, Rare Disease Program and Congenital Anomalies Program
University of Alabama at Birmingham
Birmingham, Alabama 

MedicalResearch.com: What is the background for this study?

Response: Preterm infants, especially those that are born with a birth weight of 750 grams or less, are prone to a lung disease called bronchopulmonary dysplasia (BPD) because the development of lungs in these infants takes place in an environment that has more oxygen than that available in utero. Recently, pulmonary blood vessel growth and function has been hypothesized to play a causal role in the pathogenesis of BPD. Vascular endothelial cell function has been shown to affect hyperoxia-induced lung damage in animal studies. An important source of human vascular endothelial cells is the umbilical cord of newborn infants. These human umbilical venous endothelial cells (HUVEC) have been used to measure endothelial cell function in various diseases but never in diseases related to the newborn infants from whom they were derived.

In addition, the mitochondria in various cells in our body respond to oxygen toxicity by creating, as well as consuming, reactive oxygen species (ROS) that mediate most of the effects of oxygen-induced damage. Therefore, we designed this study to measure mitochondrial function in vascular endothelial cells obtained from the umbilical cords of prematurely born infants at the time of their birth. We then compared these mitochondrial functional measures between infants who later died or developed BPD versus those who survived without BPD.

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T Cell Biomarkers Predictive of Course of IPF – Idiopathic Pulmonary Fibrosis

MedicalResearch.com Interview with:

Catherine Bonham MD Section of Pulmonary and Critical Care Medicine University of Chicago

Dr. Bonham

Catherine Bonham MD
Section of Pulmonary and Critical Care Medicine
University of Chicago

MedicalResearch.com: What is the background for this study?

Response: Idiopathic pulmonary fibrosis (IPF) causes fibrosis, or scar tissue, to form in the lungs. People with IPF become more and more short of breath and need oxygen. It is progressive and we don’t have any cure. Prognosis is about 3 to 5 years, worse than many cancers. We don’t know what causes it. It is a leading indication for lung transplant.

Many doctors and scientists are skeptical about the role of the immune system in IPF because some immune-directed treatments, like steroids, have been tried and failed. However, recent research shows that the expression of genes in patients who do well with IPF is different from patients who do poorly and die rapidly from IPF. The difference in survival was in genes expressed by their immune systems, specifically their T cells. We have known for decades that T cells are a type of white blood cell specialized for fighting infection. In the last several years, doctors and scientists made the amazing discovery that T cells also fight cancer within the body. Many new immune therapies have now been developed that can make some patients cancer-free. It was very exciting to think that T cells could also affect survival in pulmonary fibrosis.

My study followed 59 patients with Idiopathic pulmonary fibrosis for up to 5 years, and examined whether we could measure two molecules on the surface of CD4 T cells, and use them to predict survival for patients with IPF. These molecules are called ICOS and CD28. They function to activate the T cells, which creates a chain reaction activating other parts of the immune system.

A second part of my study looked at the lungs and lymph nodes from 9 IPF patients who generously donated their old lungs to research after they received lung transplant. The purpose of this was to find if what I see in blood samples reflected what the T cells really do in the lungs.

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First Patients Enrolled in Study of Nintedanib For Progressive Fibrosing Lung Conditions

MedicalResearch.com Interview with:

Thomas Leonard, Ph.D. Executive director, Clinical Development and Medical Affairs, Specialty Care Boehringer Ingelheim Pharmaceuticals, Inc.

Dr. Thomas Leonard

Thomas Leonard, Ph.D.
Executive director, Clinical Development and Medical Affairs, Specialty Care
Boehringer Ingelheim Pharmaceuticals, Inc.

MedicalResearch.com: What is the background for this study? Would you tell us a little more about IPF?

Response: Boehringer Ingelheim’s Phase III PF-ILD (progressive fibrosing interstitial lung disease) trial will investigate the safety and efficacy of nintedanib, in a range of progressive fibrosing lung conditions other than idiopathic pulmonary fibrosis, or IPF. The PF-ILD trial is the first time that patients with different fibrosing lung diseases will be included in one single clinical trial assessing the efficacy of nintedanib as a potential treatment, and the trial is the first in the field of fibrosing lung diseases to group patients based on the clinical characteristics of their disease, rather than the diagnosis.

There are more than 200 conditions that affect the tissue and space around the air sacs of the lungs, or interstitium, and, collectively, these conditions are called interstitial lung diseases — or ILDs. Based on clinical observations, there is a group of patients with ILD who, independent from the classification of the ILD, exhibit progressive fibrosis. The proposed terminology for describing this group of patients is PF-ILD. In these patients, the disease appears to follow a course similar to IPF with worsening of respiratory symptoms, lung function, quality of life and ability to perform daily activities, as well as early mortality despite treatment.

There is currently no efficacious treatment available for PF-ILD. This trial is exploring how fibrosis in the lungs is treated and whether nintedanib is a potential treatment, based on the efficacy and safety of nintedanib in IPF, a rare and serious lung disease that causes permanent scarring of the lungs, making it difficult to breathe. IPF affects as many as 132,000 Americans, typically men over the age of 65. On average, people with IPF live only three to five years after diagnosis, and approximately 40,000 people die from this disease every year.

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Bernie Williams Discusses His Dad’s Journey With IPF and New Treatment Options

MedicalResearch.com Interview with:

Mr. Bernie Williams Four-time World Series champion and star centerfielder for the New York Yankees discusses his beloved dad Bernabé’s struggle with a rare lung disease called idiopathic pulmonary fibrosis (IPF)

Mr. Bernie Williams

Mr. Bernie Williams

Four-time World Series champion and star centerfielder for the New York Yankees discusses his beloved dad Bernabé’s struggle with a rare lung disease called idiopathic pulmonary fibrosis (IPF) 


MedicalResearch.com: Would you briefly explain what idiopathic pulmonary fibrosis is? How does it affect a person’s health and ability to breathe?

Mr. Williams: IPF is a rare and serious lung disease that causes permanent scarring of the lungs, and makes it difficult to breathe. Symptoms of IPF include breathlessness during activity, a dry and persistent cough, chest discomfort, fatigue and weakness. Although considered “rare,” IPF affects up to 132,000 Americans, and about 50,000 people in the U.S. are diagnosed every year with IPF – enough to fill a baseball stadium.

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Which Patients With Advanced Respiratory Disease Die in the Hospital?

MedicalResearch.com Interview with:

Dr Sabrina Bajwah MBChB MRCGP MSc MA PhD Consultant Palliative Medicine, King’s College NHS Foundation Trust Honorary Senior Lecturer King's College London Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation London, UK

Dr Sabrina Bajwah

Dr Sabrina Bajwah
MBChB MRCGP MSc MA PhD
Consultant Palliative Medicine, King’s College NHS Foundation Trust
Honorary Senior Lecturer
King’s College London
Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation
London, UK 

MedicalResearch.com: What is the background for this study?

Response: Where people die is often important to them and their families, as well as being important for planning health care services. Most people want to die at home, but instead most die in hospital. While the trends have been studied in cancer, other diseases, such as respiratory, are rarely looked at even though they are common and increasing causes of death.

Chronic Obstructive Pulmonary Disease (COPD) and Interstitial Pulmonary Diseases (IPD) are common respiratory conditions. Both conditions result in a high use of hospital services, especially among people in advanced stages. This leads to high healthcare costs.1 In the UK in 2010, it is estimated that IPD costs £16.2 million per year in hospitalisations.2 The NHS spends more than £810 million annually managing COPD, with inpatient stays accounting for around £250 million annually.

Understanding which factors affect place of death is vital for planning services and improving care, especially given our ageing population, rising chronic diseases and the high costs of hospital admissions. Strategies in many countries have sought to improve palliative care and reduce hospital deaths for non-cancer patients, but their effects are not evaluated.

We aimed to determine the trends and factors associated with dying in hospital in COPD and IPD, and the impact of a national end of life care (EoLC) strategy3 to reduce deaths in hospital. This study analysed a national data set of all deaths for COPD and IPD, covering 380,232 people over 14 years.

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Cystic Fibrosis Patients Survive Ten Years Longer in Canada than in US

MedicalResearch.com Interview with:
Dr. Anne L. Stephenson, MD, PhD

St. Michael’s Hospital
Toronto Canada

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Both Canada and the US have maintained national registries on individuals with cystic fibrosis (CF) dating back to the 1970s. Previous reports suggested that survival differed between the two countries however direct comparisons of survival estimates between national registry reports were limited because of differences in methodologies used, data processing techniques and possible differences in the patients captured within each registry.

We aimed to compare survival in  cystic fibrosis between Canada and the US to determine if differences existed when we applied a systematic and standardized approach.

Our analysis showed that between 1990 and 2013, survival for individuals with CF increased in both countries, however, the rate of increase was faster in Canada compared to the USA. The survival gap widened at two distinct time points: 1995 and 2005.

In the contemporary period between 2009 and 2013, the median age of survival for individuals with cystic fibrosis in Canada was found to be 50.9 years compared to 40.6 years in the US. Overall, the risk of death was 34% lower for Canadians compared Americans with CF after adjusting for markers of disease severity. When US CF subjects were classified by insurance status, we found a 77% lower risk of death among Canadians with CF compared to Americans who indicated unknown or no insurance, a 44% lower risk compared to Americans receiving continuous Medicare/Medicaid, and a 36% lower risk in Canadians compared to Americans receiving intermittent Medicare/Medicaid. The risk of death for Americans with private insurance was not statistically different from that of Canadians with cystic fibrosis .

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Effects of Riociguat in Treatment-Naïve vs Pretreated Patients With Pulmonary Arterial Hypertension

MedicalResearch.com Interview with:

Prof. Hossein-Ardeschir Ghofrani University of Giessen and Marburg Lung Center Giessen, Germany, and Member of the German Center of Lung Research and Department of Medicine Imperial College London London, UK

Prof. Ghofrani

Prof. Hossein-Ardeschir Ghofrani
University of Giessen and Marburg Lung Center
Giessen, Germany, and
Member of the German Center of Lung Research
and Department of Medicine
Imperial College London
London, UK

MedicalResearch.com: What is the background for this study?

Response: Pulmonary arterial hypertension (PAH) is characterised by increased pulmonary vascular resistance (increased resistance to blood flow in the pulmonary circulation), which can lead to right heart failure and death. Riociguat is the first of a new class of drugs – the soluble guanylate cyclase stimulators. It has been approved for the treatment of PAH based on the impressive efficacy and safety results from two pivotal Phase III studies: PATENT-1 and its long-term extension phase, PATENT-2. PATENT-1 was a 12-week, double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of riociguat in patients with PAH. Patients who completed PATENT-1 without ongoing riociguat-related serious adverse events (AEs) could enter PATENT-2, in which they received open-label riociguat. PATENT-1 admitted patients whether they were treatment-naïve or already receiving targeted PAH therapies, such as endothelin receptor antagonists (ERAs) and prostanoids. This current analysis compared the safety and efficacy of riociguat between treatment-naïve and pretreated patients in the PATENT-2 long-term extension study.

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Nanoparticles From Pollution Can Awaken Dormant Herpes Viruses in Lungs

MedicalResearch.com Interview with:

Dr. Tobias Stöger Group Leader, Dynamics of Pulmonary Inflammation Comprehensive Pneumology Center Institute of Lung Biology and Disease (iLBD) Helmholtz Zentrum München

Dr. Tobias Stöger

Dr. Tobias Stöger
Group Leader, Dynamics of Pulmonary Inflammation
Comprehensive Pneumology Center
Institute of Lung Biology and Disease (iLBD)
Helmholtz Zentrum München 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Particulate air pollution is common in urban areas and the inhalation of nanoparticles is known to trigger inflammatory effects in humans potentially altering the immune system.

Herpes viruses are ubiquitous and well adapted pathogens hiding in host cells and persist thus continuing in a greater part of our population.

Under certain stress conditions and if the immune system becomes weakened, the viruses can become active again, begin to proliferate and destroy the host cell.

Thus we raised the question whether NP-exposure of persistently herpesvirus-infected cells as a second hit might provoke reactivation of latent virus and eventually lead to an inflammatory response and tissue damage.

Our main finding is that NP-exposure of persistently herpesvirus-infected cells – murine or human – restores molecular signatures found in acute virus infection and boosts production of lytic viral proteins.

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Antipsychotics Raise Risk of Respiratory Failure in COPD

MedicalResearch.com Interview with:
Meng-Ting Wang, PhD

Associate Professor
School of Pharmacy
National Defense Medical Center
Taipei, Taiwan

MedicalResearch.com: What is the background for this study?

Response: During the past decades, there have been multiple case reports about acute respiratory distress or acute respiratory failure (ARF) from the use of antipsychotics. Nevertheless, no population-based studies have been conducted to examine this potential drug safety issue. We aimed to investigate the association between use of antipsychotics and risk of ARF in a population of chronic obstructive pulmonary disease (COPD), who is vulnerable to ARF and frequently prescribed with antipsychotics.

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Does Skin Pigmentation Affect Accuracy of Pulse Oximetry in Infants?

MedicalResearch.com Interview with:

Elizabeth Foglia, MD MSCE Assistant Professor of Pediatrics University of Pennsylvania Perelman School of Medicine Attending Neonatologist Hospital of the University of Pennsylvania The Children's Hospital of Philadelphia

Dr. Elizabeth Foglia

Elizabeth Foglia, MD MSCE
Assistant Professor of Pediatrics
University of Pennsylvania Perelman School of Medicine
Attending Neonatologist
Hospital of the University of Pennsylvania
The Children’s Hospital of Philadelphia

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Pulse oximetry is a non-invasive method of monitoring oxygen saturation that is frequently used to monitor ill newborns and infants. Previous studies of adults with hypoxemia (low blood oxygen levels) demonstrated that pulse oximetry is less accurate in adults with dark skin, compared to adults with light skin. We sought to determine if skin pigment affects the accuracy of pulse oximetry in infants with hypoxemia.
We studied 2 widely used pulse oximeters, and we did not find evidence that skin pigment affects the accuracy of pulse oximetry in infants with hypoxemia.

However, the overall performance (combined accuracy and precision) of both oximeters was poor. In addition, one oximeter (the Nellcor Oximax) consistently overestimated the measured blood oxygen level.

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Interventions to Improve Rate of Successful Extubation in Preterm Infants

MedicalResearch.com Interview with:
Kristin N. Ferguson, BSc

The Royal Women’s Hospital and
Deakin University
Melbourne, Victoria, Australia

MedicalResearch.com: What is the background for this study?

Response: Weaning preterm infants from mechanical ventilation, thereby minimising the risks of having an endotracheal tube in situ which may further damage their fragile lungs, is something all neonatal clinicians are keen to do. We provide clinicians with a straightforward list of safe and effective strategies to help them in this task, as well as pointing out some treatments to either avoid or use with caution.

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Lung Maturity Test Can Determine Which Premature Infants are at risk of RDS

MedicalResearch.com Interview with:

Prof. Henrik Verder Department of Pediatrics Holbaek University Hospital Denmark

Prof. Henrik Verder

Prof. Henrik Verder
Department of Pediatrics
Holbaek University Hospital
Denmark

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Respiratory Distress Syndrome (RDS) is a major cause of mortality and morbidity in premature infants. It can be effectively treated with surfactant, a therapy which reduces the effort needed to expand the lungs during inspiration and allow gas exchange to take place. Early surfactant treatment can help prevent the onset and impact of RDS, however, prophylactic treatment has been shown to be harmful and only necessary in half of all pre-term infants. This study provided data validating the efficacy of a lung maturity test (LMT) in identifying infants at risk of respiratory distress syndrome (RDS) who could benefit from early surfactant treatment.
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Studies Reinforce Efficacy of Ofev in Idiopathic Pulmonary Fibrosis

MedicalResearch.com Interview with:

Dr. Luca Richeldi MD PhD Professor of Respiratory Medicine Chair of Interstitial Lung Disease University of Southampton United Kingdom

Dr. Luca Richeldi

Dr. Luca Richeldi MD PhD
Professor of Respiratory Medicine
Chair of Interstitial Lung Disease
University of Southampton
United Kingdom

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The data presented at CHEST 2016 were from two post-hoc pooled analyses of the Phase III INPULSIS® trials that evaluated Ofev in idiopathic pulmonary fibrosis, or IPF. Both analyses, using different measures, demonstrate Ofev efficacy in a range of people with IPF, regardless of disease severity at the start of the trials.

One analyses investigated the efficacy of Ofev on disease progression in subgroups of patients defined by their GAP (gender, age, physiology) stage. Based on the index, patients were categorized as either GAP stage I or II/III. The analysis showed a similar reduction in disease progression with Ofev versus placebo regardless of GAP stage – meaning no significant difference between GAP stage I versus GAP stage II/III. Disease progression was defined as an absolute decline in forced vital capacity (FVC) ≥5% predicted or death over 52 weeks.

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Pulmonary Embolism May Be An Overlooked Cause of Syncope

MedicalResearch.com Interview with:

Paolo Prandoni, M.D., Ph.D.

Dr.Paolo Prandoni

Paolo Prandoni, M.D., Ph.D. and
Department of Cardiovascular Sciences
Vascular Medicine Unit
University of Padua, Padua

Sofia Barbar, M.D

Dr.Sofia Barbar

Sofia Barbar, M.D
Department of Internal and Emergency Medicine
Civic Hospital of Camposampiero
Camposampiero

MedicalResearch.com: WhaWhat are the main findings?

Response: Syncope is defined as a sudden loss of consciousness due to transient global cerebral hypoperfusion characterized by rapid onset, short duration, and spontaneous complete recovery. According to the most recent guidelines, syncope can be classified as neurally-mediated, due to orthostatic hypotension and cardiovascular. Syncope is frequent in general population and represents up to 2% of all attendances in Emergency Department in Europe. The initial approach is unable to identify a plausible cause for syncope in 25-30% of cases and approximately 40% of syncope referred to an Emergency Department is then admitted to the hospital.

Pulmonary embolism (PE) is an obstruction in the pulmonary arteries interfering with both blood circulation and gas exchange and therefore representing a potentially life-threatening event. Clinical features of PE are extremely variable.

Available guidelines on syncope management consider PE as an infrequent cardiovascular cause of syncope. However, the true prevalence of pulmonary embolism in syncope-patients it is actually unknown. Moreover a workup for PE diagnosis in these patients is not suggested in the current guidelines.
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Real World Trial Show Efficacy of Fluticasone Furoate–Vilanterol for COPD in Clinical Practice

MedicalResearch.com Interview with:
Jørgen Vestbo DMSc FRCP FERS

Professor of  Respiratory Medicine
Division of Infection, Immunity and Respiratory Medicine
University of Manchester
Education and Research Centre
University Hospital of South Manchester
Manchester

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Efficacy studies are limited in their usefulness to clinicians as there are often restricted inclusion criteria, with many exclusion criteria and patients are followed closely with high adherence to study treatment. They therefore show what the drugs can do but not necessarily what they do do in the real world.

Randomised studies in everyday practice, not limiting the entry (effectiveness trials) are therefore needed.

In our study we showed that it is feasible to do randomised studies in the “real world”.

Our study showed that a simple treatment with a once-daily combination of an inhaled corticosteroid and a long-acting beta-agonist (Breo/Relvar) was superior to the usual care chose by the patients’ general practitioners to manage their COPD.

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Extubating Patients From Ventilators At Night Linked To Higher Mortality

MedicalResearch.com Interview with:

Hayley B. Gershengorn, MD Associate Professor, Albert Einstein College of Medicine Attending Physician, Montefiore Medical Center Bronx, NY 10467

Dr. Hayley Gershengorn

Hayley B. Gershengorn, MD
Associate Professor, Albert Einstein College of Medicine
Attending Physician, Montefiore Medical Center
Bronx, NY 10467

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Little was previously known about the timing of extubations for mechanically ventilated intensive care unit patients or whether extubating patients overnight is safe. In this retrospective cohort study of mechanically ventilated intensive care unit adult patients in the United States, 20.1% were extubated overnight. Overnight extubation was associated with significantly higher hospital mortality.

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Study Raises Concerns About Sales of Secondhand CPAP Devices

MedicalResearch.com Interview with:

Ken Kunisaki, MD, MS Associate Professor of Medicine Minneapolis Veterans Affairs Health Care System and University of Minnesota

Dr. Kunisaki

Ken Kunisaki, MD, MS
Associate Professor of Medicine
Minneapolis Veterans Affairs Health Care System and University of Minnesota and

Roxanne Prichard, PhD Associate Professor of Psychology and Neuroscience University of St. Thomas

Dr. Prichard

Roxanne Prichard, PhD
Associate Professor of Psychology and Neuroscience
University of St. Thomas

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: CPAP devices, or continuous positive airway pressure devices, are used to treat obstructive sleep apnea, a common condition that causes people to intermittently stop breathing during their sleep. This leads to poor sleep quality and often results in symptoms like excessive sleepiness in the daytime. In the United States, CPAP devices are classified by the Food and Drug Administration as Class II medical devices with possible risks; their sale requires a medical prescription. We were aware of online advertisements for secondhand, used CPAP machines, but we have not seen publications that have analyzed this practice.

Once a week, our research team monitored online advertisements for secondhand CPAP devices on Craigslist.org in 18 U.S. cities and areas over a one-month period. During that time, we found 270 advertisements, most of which did not describe who previously had used the device or why it was being sold. Only 5 of the advertisements mentioned anything about the legal requirements of a prescription and 61 percent of the devices included a used mask without information about its age or how it was cleaned.

CPAP devices create air pressure and attach to a nose or face mask that delivers that pressure to a patient’s airway, thereby keeping him or her breathing during sleep. The amount of air pressure delivered by the devices is adjusted for each patient and usually is determined by a medical exam that includes an overnight stay in a laboratory. Our study found that most of the Craigslist advertisements failed to mention the devices’ pressure settings—settings that were prescribed for the original owners.

The average price for a CPAP device listed on Craigslist was $291, much less than the $600 to $2,000 cost of a new device.

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Abnormal Microbiome Found in Preterm Infants Who Develop Chronic Lung Disease

Charitharth ‘Vivek' Lal, MD Assistant Professor, Division of Neonatal-Perinatal Medicine, Departments of Pediatrics University of Alabama at Birmingham Birmingham, AL 35249-7335

Dr. Lal

MedicalResearch.com Interview with:
Charitharth ‘Vivek’ Lal, MD
Assistant Professor,
Division of Neonatal-Perinatal Medicine,
Departments of Pediatrics
University of Alabama at Birmingham
Birmingham, AL 35249-7335

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Airway microbiome of neonates, at birth, has not been studied. Also, association of airway microbiome with lung disease of prematurity has not been studied well.

We found that infant airway is already colonized with bacteria or bacterial DNA when a baby is born. The extremely low birth weight (ELBW) infants who went on to develop life-threatening bronchopulmonary dysplasia showed abnormal microbial colonization patterns at birth, as compared to pre-term infants who did not get BPD. These findings were validated from a second independent set of patients, from a different clinical site.

MedicalResearch.com: What should readers take away from your report?

Response: Early airway microbiome dysbiosis may be associated with subsequent lung diseases and presence of lactobacillus in the airway of preterm infants may be protective. In addition, the newborn may acquire the airway microbiome / bacterial DNA, transplacentally or from the amniotic fluid.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response:
• To study the effects of pulmonary microbiome in various lung disease processes.
• To study the mechanisms by which the respiratory microbiome affect host response.
• To study the gut – lung microbial axis.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

The Airway Microbiome at Birth
Charitharth Vivek Lal , Colm Travers, Zubair H. Aghai , Peter Eipers , Tamas Jilling , Brian Halloran,Waldemar A. Carlo, Jordan Keeley , Gabriel Rezonzew , Ranjit Kumar, Casey Morrow , Vineet Bhandari & Namasivayam Ambalavanan
Published online: 04 August 2016
Scientific Reports 6, Article number: 31023 (2016)
doi:10.1038/srep31023

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

More Medical Research Interviews on MedicalResearch.com

Secondhand Pot Smoke Just As Bad For Heart As Tobacco

MedicalResearch.com Interview with:

Matthew L. Springer, Ph.D. Professor of Medicine Division of Cardiology University of California, San Francisco San Francisco, CA

Dr. Matthew Springer

Matthew L. Springer, Ph.D.
Professor of Medicine
Division of Cardiology
University of California, San Francisco
San Francisco, CA

MedicalResearch.com: What is the background for this study?

Response: We’ve known for many years that secondhand smoke from tobacco cigarettes is harmful, and the vast majority of deaths thought to result from secondhand smoke are from cardiovascular disease. However, very little has been known about cardiovascular consequences of exposure to secondhand smoke from marijuana, and people tend to mistake the lack of evidence that it is harmful, for evidence that is it not harmful. As a result, many people seem relatively unconcerned about smoking marijuana and being exposed (or exposing others) to marijuana secondhand smoke. Politicians and policy makers also seem less willing to limit where people can smoke marijuana (under legal circumstances) than tobacco. What has been lacking is research into how exposure to marijuana smoke affects cardiovascular health. It has been difficult to do such experiments because marijuana is illegal in the eyes of the federal government. However, we have been studying the harmful effects of secondhand tobacco smoke on the function of rat blood vessels, which is similar to its harmful effects on human blood vessels, and we now have studied how the function of rat blood vessels is affected by exposure to secondhand marijuana smoke.

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Nintedanib – Ofev – Slows Progression in Broader Group of Idiopathic Pulmonary Fibrosis Patients

MedicalResearch.com Interview with:

Ganesh Raghu, M.D. FACP, FCCP Professor of Medicine Division of Pulmonary and Critical Care Medicine and Director of Center for Interstitial Lung Diseases Director, Interstitial Lung Disease/Sarcoid/Pulmonary Fibrosis Program University of Washington Medical Center Seattle, Washington

Dr. Ganesh Raghu

Ganesh Raghu, M.D. FACP, FCCP
Professor of Medicine
Division of Pulmonary and Critical Care Medicine and Director of Center for Interstitial Lung Diseases
Director, Interstitial Lung Disease/Sarcoid/Pulmonary Fibrosis Program
University of Washington Medical Center
Seattle, Washington

MedicalResearch.com: What is the background for this study?

Response: This is a new post-hoc analysis of the Phase III INPULSIS trials, including a total of 1,061 patients with idiopathic pulmonary fibrosis (IPF), which has been published in the American Journal of Respiratory and Critical Care Medicine.

As background, achieving an accurate diagnosis of IPF in clinical practice is very complex and challenging. Physicians use an imaging technique called high resolution computed tomography (HRCT) to help them identify the presence of scarring (fibrosis) and, specifically, the presence of usual interstitial pneumonia (UIP) pattern in the lungs. The radiological changes called “honeycombing” are the key feature of the UIP pattern visible on HRCT and the pattern of UIP is the hallmark of the fibrosis in patients with IPF. In the absence of definitive UIP pattern on HRCT images of the lungs, the diagnosis of  idiopathic pulmonary fibrosis requires the microscopic features of UIP in the surgical lung biopsy (SLB) based on current guidelines for diagnosis of IPF.

However, it can be challenging to confirm that scarring in the absence of honeycombing on HRCT meets the strict guideline criteria for a definitive diagnosis of IPF. For a large group of patients who do not receive a confirmed diagnosis of IPF according to guidelines, including those not eligible for surgical lung biopsy, the clinical course of their condition and the effectiveness of  idiopathic pulmonary fibrosis treatment remains unknown. Therefore, investigations into the behavior of the disease across diagnostic subgroups are important.

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Bronchoscopy Can Expose Health Care Workers To Pathogens in Aerosol

MedicalResearch.com Interview with:

Genevieve Marchand Ph.D., RMCCM SCCM(Env) Microbiologiste agréée & Biochimiste Chercheure, Prévention des risques chimiques et biologiques IRSST

Dr-Genevieve-Marchand

Genevieve Marchand Ph.D., RMCCM SCCM(Env)
Microbiologiste agréée & Biochimiste
Chercheure, Prévention des risques chimiques et biologiques
IRSST

MedicalResearch.com: What is the background for this study?

Response: It is well known that Health Care Workers (HCWs) are at risk of occupationally acquired infections. Some procedures, such as bronchoscopies, are recognized to be high-risk tasks. Most researches that have linked infectious risk to specific task in healthcare settings did not measure the real bioaerosol exposure. Those link where mostly made from epidemiology observations. The aim of this study was to qualify and quantify the real bioaerosol concentrations found during bronchoscopy procedures in order to estimate the true occupational risk.

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Early Rehabilitation Did Not Shorten Hospital Stay For ICU Patients

MedicalResearch.com Interview with:

Peter E. Morris, MD, FACP, FCCP Chief, Division of Pulmonary, Critical Care and Sleep Medicine University of Kentucky Lexington, KY

Dr. Peter Morris

Peter E. Morris, MD, FACP, FCCP
Chief, Division of Pulmonary, Critical Care and Sleep Medicine
University of Kentucky
Lexington, KY

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: ICU survivors demonstrate weakness. It has been postulated that interventions to promote early rehabilitation strategies might be linked to improved functional outcomes for ICU survivors.

This study was based upon findings from a quality improvement endeavor that linked early rehabilitation with indications of shortened hospital stays for ICU survivors.

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Marijuana Smoke Could Have Similar Effects on Lungs as Tobacco

MedicalResearch.com Interview with:

Stefania I. Papatheodorou, MD, PhD Cyprus International Institute for Environmental and Public Health Limassol, Cyprus

Dr. Stefania Papatheodorou

Stefania I. Papatheodorou, MD, PhD
Cyprus International Institute for Environmental and Public Health
Limassol, Cyprus

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Marijuana is the most commonly used illicit drug in the United States. Despite increasing use and acceptance of marijuana, both medically and recreationally, gaps remain in our knowledge regarding potential health effects.

In this study, we aimed to evaluate associations between recent marijuana use, exhaled Nitric Oxide (eNO) and pulmonary function. We performed a cross-sectional study of 10,327 US adults participating in the National Health and Nutrition Examination Survey (NHANES) in the years 2007 to 2012.

Exhaled Nitric Oxide was lower among participants who used marijuana in the past 0 to 4 days and those who last used marijuana 5 to 30 days before the examination compared with the never users. FEV1 was higher among participants who used marijuana within 0 to 4 days before the examination compared with those who never used marijuana, while FVC was higher in both past and current marijuana users compared with never users. The FEV1/FVC ratio was significantly lower among those who used marijuana in the 0 to 4 days before the examination compared with never users.

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Persistent Childhood Asthma Linked to Long-Term Lung Function Deficits

MedicalResearch.com Interview with:

Dr. James P. Kiley Ph.D National Institutes of Health Bethesda Maryland

Dr. James Kiley

Dr. James P. Kiley Ph.D
National Institutes of Health Bethesda
Maryland 

MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Kiley: While a higher proportion of children have asthma compared to adults, the disease is limited to childhood for many individuals who appear to be unaffected as adults. Regardless of whether asthma continues into adulthood or reoccurs during adulthood, the impact of childhood asthma on lung function later in life is unclear. This study demonstrated that in children with chronic persistent asthma at the age of 5-12 years who continued to be followed through their early twenties, 75% of them had some abnormality in the pattern of their lung growth. The study examined the trajectory of lung growth, and the decline from maximum growth, in a large cohort of persons who had persistent, mild-to-moderate asthma in childhood and determined the demographic and clinical factors associated with abnormal patterns of lung growth and decline.
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Children With Persistent Asthma At Risk For Future Lung Disease

MedicalResearch.com Interview with:

Michael McGeachie, PhD Instructor in Medicine Harvard Medical School Channing Division of Network Medicine Brigham and Women's Hospital

Dr. Michael McGeachie

Michael McGeachie, PhD
Instructor in Medicine
Harvard Medical School
Channing Division of Network Medicine
Brigham and Women’s Hospital

MedicalResearch.com: What is the background for this study?

Dr. McGeachie: In asthma, and in general but particularly in asthma, a person’s level of lung function has a big impact on his or her quality of life, level of respiratory symptoms and complications, and general morbidity. In asthma, low lung function leads to greater severity and frequency of asthma symptoms. Asthma is a common childhood illness, affecting 9-10% of children. Many children grow out of asthma as they become adults, but other asthmatics remain effected through adulthood, which can lead to a lifetime of respiratory symptoms and chronic airway obstruction, including chronic obstructive pulmonary disease (COPD).

If you consider lung function longitudinally, throughout development, plateau, and decline, different people and different asthmatics tend to exhibit different patterns of lung function. Healthy, non-asthmatic people tend to have a period of rapid lung function increase in adolescence, a plateau of lung function level in their late teens and early 20s, and starting around 25 or so a slow, gradual decline of lung function that continues throughout old age. We call this Normal Growth of lung function. However, some people exhibit Reduced Growth, where they don’t reach their expected maximum lung function for a person of the same age, sex, height, and race. Others can show Early Decline, who might reach a normal maximum but then begin to decline immediately without a plateau or with a truncated plateau. We hypothesized that these patterns, Reduced Growth and Early Decline, might have different baseline indicators, precursors, outcomes, and risk of developing COPD.

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Eosinophil Count Identifies COPD Patients Who May Benefit From Inhaled Steroids

MedicalResearch.com Interview with:

Danny MvBryan, MD Vice president, Clinical Development & Medical Affairs, Respiratory Boehringer Ingelheim Pharmaceuticals, Inc.

Dr. Danny MvBryan

Danny McBryan, MD
Vice president, Clinical Development & Medical Affairs, Respiratory
Boehringer Ingelheim Pharmaceuticals, Inc.

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. MvBryan: The new post-hoc analysis from the WISDOM study shows a routine blood test could help identify the small minority of patients with severe or very severe COPD who may benefit from the addition of inhaled corticosteroids (ICS). This post-hoc analysis was recently published online in The Lancet Respiratory Medicine.

For 80 percent of patients in the WISDOM study, the use of ICS on top of SPIRIVA HANDIHALER (a long-acting muscarinic antagonist – LAMA) and salmeterol (a long-acting beta-agonist – LABA) had no additional benefit in reducing the risk of exacerbations, compared to SPIRIVA HANDIHALER and the LABA without ICS.

The post-hoc analysis shows that these patients can be easily identified by measuring the level of white blood cells, called eosinophils. Patients with levels lower than 4 percent (300 cells/µL) were associated with a lack of response to ICS.

The WISDOM study evaluated stepwise withdrawal of inhaled corticosteroids (ICS) in severe to very severe COPD patients with a history of exacerbation. WISDOM was a 12-month, double-blind, parallel-group, active-controlled study in which all patients received triple therapy (tiotropium 18 μg once daily, salmeterol 50 μg twice daily and fluticasone 500 μg twice daily) for a six-week run-in period. Patients were randomized 1:1 to continue triple therapy or stepwise withdrawal of ICS over 12 weeks (dose reduction every six weeks).

The WISDOM data show that in patients with severe to very severe COPD, the risk of moderate/severe exacerbations during one year of follow-up was non-inferior between those patients who continued on inhaled corticosteroids and those where ICS therapy was withdrawn in a stepwise manner.

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Simple Blood Test To Identify COPD Patients Who Will Benefit from Inhaled Steroids

MedicalResearch.com Interview with:
Dr Henrik Watz MD
Pulmonary Research Institute at Lung Clinic Grosshansdorf
Airway Research Center North, German Center for Lung Research
Grosshansdorf, Germany

Medical Research: What is the background for this study? What are the main findings?

Dr Watz : While bronchodilators are the mainstay therapy for all patients with COPD some patients benefit from the addition of inhaled corticosteroids in case of frequent exacerbations. So far only little data exist that help clinicians to better characterize those patients that may benefit from the continuation of inhaled corticosteroids on top of dual bronchodilation with a LABA and a LAMA.

Post-hoc analyses of the WISDOM dataset suggest that those patients, who have blood eosinophil counts of 4 % or greater or 300 eosinophils per µL or more have less exacerbations, when inhaled corticosteroids are continued compared to patients, in whom inhaled corticosteroids are withdrawn. Patients with less than 4 % eosinophils or less than 300 eosinophils in peripheral blood, who represent 80 % of the study population in WISDOM, did not benefit from a continuation of inhaled corticosteroids.

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Task Force Recommends Against Routine COPD Screening in Asymptomatic Adults

MedicalResearch.com Interview with:

Dr. William Phillips MD MPH USPSTF Task Force member and Theodore J. Phillips Endowed Professor in Family Medicine University of Washington, Seattle. Dr. Phillips is also a founder and senior associate editor of the Annals of Family Medicine

Dr. William Phillips

Dr. William Phillips MD MPH
USPSTF  Task Force member and
Theodore J. Phillips Endowed Professor in Family Medicine
University of Washington, Seattle. Dr. Phillips is also a founder and senior associate editor of the Annals of Family Medicine

MedicalResearch.com: What is the background for this study? What are the main findings? 

Dr. Phillips: Chronic obstructive respiratory disease, or COPD, is a serious, chronic condition that affects a person’s ability to breathe. It is the third leading cause of death in the United States. When the Task Force reviewed the research on screening adults for COPD in a primary care setting, we concluded with moderate certainty that screening has no net benefit, which is why we do not recommend screening for COPD in people who do not have symptoms.

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First Trimester Use of Rhinocort Linked To Respiratory Defects in Newborns

MedicalResearch.com Interview with:
Anick Bérard PhD FISPE
Research chair FRQ-S on Medications and Pregnancy and
Director Réseau Québécois de recherche sur le médicament (RQRM) and
Professor, Research Chair on Medications, Pregnancy and Lactation
Faculty of Pharmacy,University of Montreal
and Director, Research Unit on Medications and Pregnancy
Research Center
CHU Ste-Justine

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Intranasal corticosteroid (Nasacort) use during pregnancy for the treatment of seasonal allergies has increased over the past decade. Nasacort is now available over the counter since October 2013 in the US and January 2015 in Canada. Given that seasonal allergies are prevalent during pregnancy and that a medication available over-the-counter is likely to be used frequently, we aimed to study the risk of using Nasacort during gestation. Furthermore, given the potential public health impact, the objectives of our study were to assess the safety of intranasal triamcinolone exposure during pregnancy on the occurrence of major congenital malformations, small-for-gestational-age (SGA) newborn, and spontaneous abortions.

Use of intranasal triamcinolone during the first trimester of pregnancy was not significantly associated with the risk of overall congenital malformations (OR 0.88, 95%CI 0.60-1.28; 31 exposed cases) compared to non-exposure; it was however associated with the risk of respiratory defects (OR 2.71, 95%CI 1.11-6.64; 5 exposed cases). This is important given that a medication given for the treatment of respiratory diseases is associated with respiratory defects in newborns.

Pregnancy exposure to intranasal triamcinolone was not significantly associated with the risk of spontaneous abortions (OR 1.04, 95%CI 0.76-1.43; 50 exposed cases). No association was found between 2nd or 3rd trimester exposure to intranasal triamcinolone and the risk of SGA (OR 1.06, 95%CI 0.79-1.43; 50 exposed cases).

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New Study Does Not Support Antacids for All Patients With IPF

MedicalResearch.com Interview with:

Prof Michael Kreuter Center for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Critical Care Medicine, Thoraxklinik, University of Heidelberg and Translational Lung Research Center Heidelberg, Germany

Dr. Michael Kreuter

Prof Michael Kreuter
Center for Interstitial and Rare Lung Diseases,
Pneumology and Respiratory Critical Care Medicine,
Thoraxklinik, University of Heidelberg and Translational Lung Research Center
Heidelberg, Germany

MedicalResearch.com: What is the background for this study? What are the main findings?

Prof. Kreuter: Already in the 70s, early reports hypothesized a relationship between gastroesophageal reflux disease (GERD) and pulmonary fibrosis (IPF). Since then, clinical and preclinical data suggested that micro-aspirations cause lung parenchymal injuries which may stimulate pulmonary fibrosis.

The hypothesis of a potential relationship between idiopathic pulmonary fibrosis (IPF_ and GERD also provoked the question of an effect of GERD-treatment by antacid therapy (i.e. proton pump inhibitors or H2-blockers) on the course of IPF.  In this context, two analyses, one retrospective and one post hoc, reported that antacid treatment had positive effects on the course of pulmonary function and on survival in IPF patients. These data lead to a conditional recommendation for the treatment of patients with IPF with antacid therapy in the current international IPF guideline.

However, the low confidence in estimates of the effect prompted us to initiate a new post-hoc analysis pooling data from the placebo arms of three multinational trials on pirfenidone in interstitial pulmonary fibrosis. In this new analysis, published in Lancet Respiratory Medicine, antacid therapy was not associated with a slower disease progression in IPF. Moreover, in patients with advanced disease antacid therapy was associated with a significantly higher incidence of pulmonary and non-pulmonary infections.

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Kinase Inhibitor Ofev Slows Progression of Idiopathic Pulmonary ibrosis

MedicalResearch.com Interview with –
Professor Luca Richeldi
University Hospital, Southampton
Southampton, UK

MedicalResearch.com: What is the background for this study? What are the main findings?

Prof. Richeldi: The pooled analysis published in Respiratory Medicine is based on Ofev (nintedanib) data from the Phase II TOMORROW trial and the two Phase III INPULSIS studies, and a total of 1,231 patients with idiopathic pulmonary fibrosis (IPF), 723 of whom were treated with Ofev. The results of this analysis confirm that Ofev significantly slows disease progression by approximately 50%, as measured by decline in forced vital capacity (FVC) across a range of patient types in the clinical trial program. In addition, the analysis confirms that Ofev reduces the risk of acute exacerbations by approximately 50% and has a favorable effect across mortality outcomes with a trend in lower all-cause mortality and a significant lower on-treatment-mortality.

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New ThoraXS Device Rapidly Decompresses Pneumothorax

MedicalResearch.com Interview with:

Dr. Ariel Drori MD Hadassah Medical Center

Dr. Ariel Drori

Dr. Ariel Drori MD
Hadassah Medical Center 

MedicalResearch.com: What is the background for the ThoraXS device?

Dr. Drori: The initial recognition of the need for a device like ThoraXS first came to me on an operational deployment during my reserve service where I serve as a military doctor. While serving on the Gazan border, I was called to a battle scene to treat a soldier who was suffering from pneumothorax after being shot in the chest.  A quick evacuation by helicopter meant that I didn’t have the time to perform the entire procedure and I was forced to hand over a partially-treated patient whose condition was unstable.

The reality of constant combat injuries mixed with a rising number of daily civilian terror attack casualties led us to understand that we need to provide a cheap, easy to use, robust and reliable solution that on the one hand can withstand the most extreme combat conditions and on the other, be used by any paramedic and in any pre-hospital and hospital setting.

This line of thought eventually led to the adoption of ThoraXS’s simple yet sophisticated mechanical mechanism that ticks all the boxes.

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CPAP Benefits Sleep and Blood Pressure in Diabetics, But Not Glucose Control

MedicalResearch.com Interview with:

Jonathan Shaw MD, FRACP, FRCP (UK), FAAHMS Associate Professor Domain Head, Population Health Research Baker IDI Heart and Diabetes Institute Melbourne VIC 3004

Dr. Jonathan Shaw

Jonathan Shaw MD, FRACP, FRCP (UK), FAAHMS
Associate Professor
Domain Head, Population Health Research
Baker IDI Heart and Diabetes Institute
Melbourne VIC 3004

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Shaw: Over the last decade or so, there has been a lot of research connecting obstructive sleep apnoea with type 2 diabetes. They co-exist very frequently in the same individual, they are both much more common in overweight and obese people than in people of healthy weights, both improve with weight loss, and both are associated with other conditions such as hypertension and heart disease. In addition, there has been evidence that some of the key abnormalities occurring in sleep apnoea (in particular, fragmented sleep and intermittent low oxygen levels) may have a direct effect on glucose metabolism, and increase blood sugar levels. This led many people to suspect that untreated sleep apnoea might be one reason that type 2 diabetes is hard to control, and that treating sleep apnoea in people with type 2 diabetes would improve their blood sugar control.

We, therefore, undertook a large trial among people with type 2 diabetes, and previously unrecognised sleep apnoea, in which participants were randomised to either a group receiving specific treatment for sleep apnoea (continuous positive airways pressure, or CPAP, therapy at night) or to a control group.

Over the six months of the trial, we saw no benefit of CPAP therapy in regard to blood sugar control (as measured by HbA1c). Even when we looked at sub-groups with worse blood sugar control at the start or worse sleep apnoea or who did the best in terms of using CPAP every night, there was still no sign of benefit on blood sugar control. We did, however, see some other benefits of CPAP therapy, with less daytime sleepiness, improvements in quality of life and lower diastolic blood pressure.

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Insufficient Evidence N95 Respirators Protect Health Care Workers From Respiratory Infections Better Than Face Masks

MedicalResearch.com Interview with:
Dr. Gary Garber MD
Chief of infection prevention and control
Public Health Ontario
Professor of medicine
University of Ottawa 

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Garber: There are conflicting recommendations regarding the use of respirators vs face masks to protect healthcare workers against acute respiratory infections. Our systematic review and meta-analysis show that although N95 respirators have improved efficiency in reducing filter penetration under laboratory conditions, there is insufficient data to show a protective advantage compared to surgical mask in clinical settings.

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Oxygen Saturation Poor Predictor of Return Visits For Infant Respiratory Infections

MedicalResearch.com Interview with:

Suzanne Schuh, MD, FRCP(C), ABPEM The Hospital for Sick Children affiliated with the University of Toronto

Dr. Suzanne Schuh

Suzanne Schuh, MD, FRCP(C), ABPEM
The Hospital for Sick Children affiliated with the
University of Toronto

Medical Research: What is the background for this study?

Dr. Schuh: Routine measurement of oxygen saturation in bronchiolitis is sometimes used as a proxy for illness severity, despite poor correlation between these parameters. This focus on oximetry may in part relate to lack of evidence on the natural history of desaturations in bronchiolitis which are often transient, and frequently not accompanied by increased respiratory distress. Desaturations occurring in infants with mild bronchiolitis in an ED often result in hospitalizations or prolonged hospital stay. They occur in healthy infants and may also occur in infants with mild bronchiolitis at home.

The main objective of this study of infants with acute bronchiolitis was to determine if there is a difference in the proportion of unscheduled medical visits within 72 hours of ED discharge in infants who desaturate during home oximetry monitoring versus those without desaturations. Our study shows that the majority of infants with mild bronchiolitis experience desaturations after discharge home.

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Being Born in Winter, or To A Smoker, Worsens Children’s Lung Health

MedicalResearch.com Interview with:

Dr. med. Julia Dratva, MD MPH Medical Specialist Prevention and Public Health - FMH Scientific project leader MAS Versicherungsmedizin/Studienkoordinationleitung

Dr. Julia Dratva

Dr. med. Julia Dratva, MD MPH         
Medical Specialist Prevention and Public Health
FMH  Scientific project
leader
MAS Versicherungsmedizin/Studienkoordinationleitung
Dept. Epidemiology and Public Health
Swiss Tropical and Public Health Institute
Socinstrasse 57, P.O. Box, 4002 Basel,
Switzerland

Medical Research: What is the background for this study? What are the main findings?

Dr. Dratva: Early childhood is a critical time window for subsequent health. Early life environment is known to be important for lung development and respiratory health. Little is known on the potential impact on lung ageing and the potential mechanisms responsible for the long-term impact. We investigated early childhood factors and their association with lung function decline, a common marker of lung aging, in two long-standing adult cohorts, SAPALDIA and ECRHS. As recently published in scientific journal PlosONE, maternal smoking, early respiratory infections or season of birth are associated with a faster decline in lung function decline, while less rapid decline was found in persons who had attended daycare. The early exposures may not only have an independent adverse effect on lung aging but also increase the respiratory vulnerability to other adult risk factors. Stronger effects were observed in in smokers exposed to the aforementioned adverse factors.

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Harmful Effects of Air Pollution Can Last Decades

MedicalResearch.com Interview with:

Dr Rebecca Ghosh, Research Associate Small Area Health Statistics Unit (SAHSU) MRC-PHE Centre for Environment and Health Imperial College London St Mary's Campus, Norfolk Place, Londo

Dr. Rebecca Ghosh

Dr Rebecca Ghosh, Research Associate 
Small Area Health Statistics Unit (SAHSU)
MRC-PHE Centre for Environment and Health
Imperial College London
St Mary’s Campus, Norfolk Place, London 

Medical Research: What is the background for this study? What are the main findings?
Dr. Ghosh: Since the 1950s a lot of evidence has accumulated that high levels of air pollution cause harmful effects on health.  However there is limited evidence on the very long term (>25 years) effects of air pollution.  Our study is one of the longest running to date looking at air pollution and mortality, following 368,000 people in England and Wales for 38 years.  We estimated air pollution exposures throughout England & Wales for 1971, 1981, 1991 and 2001 using data from historic air pollution monitoring networks, the first time this has been done.

We found that air pollution exposure in 1971 was still associated with a small increased risk of death in 2002-9, over 30 years later, suggesting that harmful effects of air pollution are extremely long-lasting.  However, risks from an individual’s past exposures waned over time and their more recent exposures gave the highest mortality risks.

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Acute Respiratory Distress Syndrome Often Underrecognized, Has High Mortality

MedicalResearch.com Interview with:

John G. Laffey MD Chief, Department of Anesthesia; Co-Director, Critical illness and Injury Research Centre; Scientist, Keenan Research Centre for Biomedical Science ‑ St. Michael's Hospital Professor, Anesthesia, Critical Care, and Physiology ‑ University of Toronto

Dr. John Laffey

John G. Laffey MD
Chief, Department of Anesthesia; Co-Director, Critical illness and Injury Research Centre; Scientist, Keenan Research Centre for Biomedical Science ‑ St. Michael’s Hospital
Professor, Anesthesia, Critical Care, and Physiology ‑ University of Toronto

Medical Research: What is the background for this study?

Dr. Laffey: Acute respiratory distress syndrome is the commonest cause of severe acute respiratory failure in the critically ill. ARDS is a major cause of death and disability in the critically ill worldwide. Second, there is no treatment for ARDS, and our present management approaches are limited to supporting organ function while treating the underlying causes

We performed the LUNG SAFE study to address several clinically important questions regarding ARDS.

First, the current incidence in a large international cohort was not known. Large regional differences had been suggested: for example, the incidence of ARDS in the US was reported to be ten times greater of that in Europe_ENREF_4.

Second, we wanted to understand how we manage patients with  Acute respiratory distress syndrome in the ‘real world’ situation. Specifically, it was not clear to what extent newer approaches to artificial ventilation, such as reducing the size of the breaths (lower tidal volumes) and keeping the lung pressure positive at all times to minimize collapse (PEEP) were used. The impact of studies showing promise for other measures to improve gas exchange such as turning patients prone during mechanical ventilation, or using neuromuscular blockade, on routine clinical practice in the broader international context was not known.

Third, there were some concerns over the extent of clinician recognition of ARDS. This was an important issue because implementation of the effective therapies may be limited by lack of recognition of ARDS by clinicians. A better understanding the factors associated with ARDS recognition and how this recognition influenced patient management could lead to effective interventions to improve care.

Lastly we wanted to determine the outcome from  Acute respiratory distress syndrome in a global cohort of patients.

Medical Research: What are the main findings?

Dr. Laffey: We found that ARDS continues to represent an important public health problem globally, with 10% of ICU patients meeting clinical criteria for ARDS. While there appeared to be some geographic variation, this did not seem as great as previously thought.

An important finding was the under-recognition of  Acute respiratory distress syndrome by clinicians, with 40% of all cases not being recognized.

In addition, over one third of patients did not receive protective lung ventilation strategies. The use of other measures to aid gas exchange during artificial ventilation, such as turning the patient into the prone position, or the use of neuromuscular blockade was also quite low.

Of most concern, ARDS continues to have a very high mortality of approximately 40% of patients dying in hospital.

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Wheezing in Early Childhood Linked to Reduced Lung Function By Adolescence

MedicalResearch.com Interview with:

Dr. Meghan B. Azad PhD Assistant Professor Department of Pediatrics & Child Health and Community Health Sciences University of Manitoba Associate Investigator, Canadian Healthy Infant Longitudinal Development (CHILD

Dr. Meghan Azad

Dr. Meghan B. Azad PhD
Assistant Professor Department of Pediatrics & Child Health and Community Health Sciences University of Manitoba and
Children’s Hospital Research Institute of Manitoba
Associate Investigator, Canadian Healthy Infant Longitudinal Development (CHILD) Study

Medical Research: What is the background for this study?

Dr. Azad: Asthma is the most common reason for children to miss school or be admitted to hospital, and accounts for over 30% of Canadian healthcare billings for children. Although many treatments exist to manage asthma symptoms, it is a lifelong disease and there is no cure.  Prevention is the best approach to reduce the global burden of asthma, and our study provides important new information to inform asthma prevention strategies.  

Medical Research: What are the main findings?

Dr. Azad: Wheezing is common in babies and young children.  Our study looked at the long-term implications of wheezing in early life, using data from the Canadian Asthma Primary Prevention Study (CAPPS).

We followed 320 children from Winnipeg and Vancouver from before birth until adolescence, and found that specific patterns of early wheezing (from age 0 to 7) were associated with decreased lung function and increased risk for asthma by age 15.

By age 15, children who wheezed consistently through infancy and early childhood had the worst lung function (9% lower compared to non-wheezers) and the highest asthma risk (11 times higher). Even children with “transient early wheeze” (those who wheezed as babies but not as young children) had reduced lung function (5% lower) and increased asthma risk (4 times higher) as teenagers.

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Frailty Linked To Lower Survival in Lung Transplant Patients

Cassie Kennedy, M.D. Pulmonology and Critical Care Medicine Mayo Clinic

Dr. Cassie Kennedy

MedicalResearch.com Interview with:
Cassie Kennedy, M.D.
Pulmonology and Critical Care Medicine
Mayo Clinic 

Medical Research: What is the background for this study?

Dr. Kennedy: Lung transplant is a surgical procedure that can offer extended life expectancy and improved quality of life to selected patients with end-stage lung disease. However there are about 1700 patients awaiting lung transplant at any given time in the United States because transplant recipients far exceed potential donors.  In addition, even with carefully chosen candidates, lung transplant recipients live on average about 5.5 years.  It is therefore very important for transplant physicians to choose patients who will receive the most benefit from their lung transplant.

Frailty (defined as an increased vulnerability to adverse health outcomes) has typically been a subjective consideration by transplant physicians when choosing lung transplant candidates.  The emergence of more objective and reproducible frailty measures from the geriatric literature present an opportunity to study the prevalence of frailty in lung transplant (despite that subjective screening) and to determine whether the presence of frailty has any impact on patient outcomes.

Medical Research: What are the main findings?

Dr. Kennedy: Frailty is quite common –46 percent of our patient cohort was frail by the Frailty Deficit Index. We also saw a significant association between frailty and worsened survival following lung transplantation: one-year survival rate for frail patients was 71.7 percent, compared to 92.9 percent for patients who were not frail. At three years this difference in survival persisted–the survival rate for frail patients was 41.3 percent, compared to 66.1 percent for patients who were not frail.

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No Evidence That Tylenol Beneficial in Flu Infections

MedicalResearch.com Interview with:
Dr. Irene Braithwaite
Deputy Director
Medical Research Institute of New Zealand
Wellington NZ

Medical Research: What is the background for this study? What are the main findings?

Dr. Braithwaite: We know from animal models that the reduction of fever is associated with an increased risk of dying from influenza. We also know that some influenza viruses cannot replicate well in the human febrile range (38 to 40 Celsius). Yet, guidelines on the management of community acquired influenza infection in humans is to rest, maintain hydration and to take antipyretics such as paracetamol on the basis that this may help and is unlikely to cause harm. We undertook this study to see whether using regular paracetamol during influenza infection might be harmful, as it may allow the influenza virus to replicate more readily, and increase and/or prolong symptoms.

To the best of our knowledge, this is the first randomised controlled trial comparing the effects of regular paracetamol (1gram four times daily for five days) versus placebo in human adults infected with influenza. We found that there was no difference in influenza viral loads, temperature or influenza symptoms between the regular paracetamol group and placebo group.

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Surveillance Data Released for Treatment of Idiopathic Pulmonary Fibrosis with OFEV-Nintedanib

Imre Noth, M.D. Professor of Medicine and Director of the Interstitial Lung Disease Programme The University of Chicago

Imre Noth, M.D.

MedicalResearch.com Interview with:
Imre Noth, M.D.
Professor of Medicine and Director of the Interstitial Lung Disease Programme
The University of Chicago

Medical Research: What is the background for this study? What are the main findings?

Dr. Noth: In 2014, OFEV® (nintedanib) became one of the first FDA-approved drug treatments for idiopathic pulmonary fibrosis (IPF), a rare and serious lung disease that causes permanent scarring of the lungs. In this post-marketing surveillance study in the United States, treatment with OFEV in the real-world clinical setting showed a safety profile consistent with that observed in clinical trials supporting its approval by the FDA.

Post-marketing surveillance of the safety and tolerability of OFEV in the United States has been collected in the Boehringer Ingelheim drug safety and reporting database since OFEV was first approved on October 15, 2014. Until May 31, 2015, 3,838 people were treated with OFEV for a length of time ranging from 14 to 265 days (on average 88 days).  The most frequently reported side effects were gastrointestinal in nature and included diarrhea, nausea, vomiting and decreased appetite. Diarrhea was the most frequently reported individual side effect, occurring at a similar frequency to that observed in the clinical trials supporting approval. No new safety concerns were identified.

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New Step Toward Gene Cure For Cystic Fibrosis

MedicalResearch.com Interview with:
Dragana Vidovic and Marianne Carlon

Laboratory for Molecular Virology and Gene Therapy
KU Leuven, Belgium

Medical Research: What is the background for this study? What are the main findings?

Response: Cystic fibrosis (CF) or mucoviscidosis is a genetic disorder caused by mutations in the CFTR gene which codes for a chloride/bicarbonate channel that regulates fluid secretion across the epithelium in different organs, for instance, the airways and the gastrointestinal tract. In the cells of CF patients, these anion channels are dysfunctional or even absent leading to the formation of sticky mucus. Persistent airway infection is the major clinical manifestation. The symptoms can be treated, but there is no cure for the disorder. Gene therapy holds promise to cure the disease. Previous studies suggested that the treatment is safe, but largely ineffective for Cystic fibrosis patients. However, as gene therapy has recently proven successful for inherited disorders such as haemophilia and congenital blindness, we wanted to re-examine its potential for CF.

Here we developed an improved gene therapy treatment based on inserting the CFTR gene into the genome of a recombinant AAV viral vector (rAAV), which is derived from the relatively innocent AAV virus. We used this vector to “smuggle” a healthy copy of the CFTR gene into the affected cells. We administered rAAV to CF mice via their airways. Most of the mice recovered. In patient-derived intestinal cell cultures or organoids, chloride and fluid transport was restored.

Medical Research: What does the study add to the field?

Response: Development of Cystic fibrosis gene therapy requires a thorough preclinical examination of a candidate vector in relevant cell and animal models before being administered to humans. Here, both in mice with Cystic fibrosis and in mini-guts or intestinal organoids derived from Cystic fibrosis patients, this approach yielded positive results setting the stage for further validation in large animal models which mimic the CF patient situation more faithfully. We believe that our study will revive the interest in CF gene therapy as a promising, mutation-independent approach to ultimately cure Cystic fibrosis.

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Veterans with PTSD Require More Sedatives in Critical Care Units

Jad Kebbe, MD Jacobs School of Medicine and Biomedical Sciences Department of Medicine University of Buffalo

Dr. Jad Kebbe

MedicalResearch.com Interview with:
Jad Kebbe, MD
Jacobs School of Medicine and Biomedical Sciences
Department of Medicine
University of Buffalo

Medical Research: What is the background for this study? What are the main findings?

Dr. Kebbe: This study proceeded after sensing that post-traumatic stress disorder (PTSD) was a major contributor to ill outcomes in Veterans who are hospitalized in general, and mechanically ventilated in the intensive care unit (ICU) in particular. There is plenty of data depicting the comorbid roles PTSD plays in other medical conditions, leading to an increase in the use of medical services. Furthermore, PTSD affects a Veteran’s adherence to both medical and psychiatric therapies. Having said this, the ICU course could itself negatively affect a pre-existing PTSD, or even lead to the inception of such a condition de novo. However, to date, there has been no study looking at the effect a pre-existing PTSD diagnosis may have on the ICU hospitalization and thereafter.

Our study confirmed that PTSD led to an increase in sedative requirements (opiates and benzodiazepines) for Veterans who were mechanically ventilated for more than 24h between 2003 and 2013, and revealed a trend towards an increase in mortality when compared to Veterans not suffering from PTSD.

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