MedicalResearch.com Interview with: Dr Andrew Conway Morris Wellcome Trust Clinical Research Career Development Fellow University of Cambridge Hon Consultant in Intensive Care Medicine Addenbrookes Hospital, Cambridge MedicalResearch.com: What is the background for this study? Response: Patients with COVID-19 frequently need to come to the intensive care unit (ICU), where we use mechanical ventilation to support their lungs as they get over the intense inflammation caused by the virus. During the first wave of the virus we noted that a lot of our patients appeared to be developing secondary infections (infections they didn’t have when they came into the ICU). We therefore rolled out a rapid diagnostic test for these secondary bacterial infections that we had developed previously, and this study reports the use of this diagnostic and also describes the types of bacteria seen. To see if the increase in secondary infections was due to COVID specifically, we compared them to patients who were managed in the same ICU but who did not have COVID. (more…)
MedicalResearch.com Interview with: Frank Trudo, MD MBA Vice President, US Medical Affairs Respiratory & Immunology AstraZeneca MedicalResearch.com: What is the background for this study? Response: ETHOS is a randomized, double-blinded, multi-center, parallel-group, 52-week trial to assess the efficacy and safety of PT010 in symptomatic patients with moderate to very severe COPD and a history of exacerbation(s) in the previous year. Outcomes in the ETHOS trial included, as a primary endpoint, the rate of moderate or severe exacerbations. MedicalResearch.com: How does PT010 differ from other treatments for COPD?
Highly competitive: PT010’s Phase III clinical trial program demonstrates it has a highly competitive clinical profile in decreasing moderate or severe exacerbations. Severe exacerbations were defined as exacerbations leading to hospitalization or death.
All-cause mortality: In a secondary endpoint, PT010 showed a 46% reduction in the risk of all-cause mortality compared with glycopyrronium/formoterol fumarate. The data from ETHOS show that reducing risk of all-cause mortality is achievable for patients with this progressive disease and could transform treatment goals in COPD.
Two potential dose options: This is also the first time we have seen the benefit of closed triple-combination therapy at two ICS doses, which could transform care by allowing physicians to select the optimal dosing option for individual patients.
MedicalResearch.com Interview with: Donald Zoz, M.D. Director, Clinical Development and Medical Affairs Respiratory Specialty Care Boehringer Ingelheim Pharmaceuticals, Inc. MedicalResearch.com: What is the background for this announcement? Would you briefly explain what is meant by systemic sclerosis and how it affects lung function?Response: In September, the U.S. Food and Drug Administration (FDA) approved Ofev as the first and only therapy to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). The FDA granted priority review and Fast-Track designation earlier this year. Interstitial lung disease (ILD) is characterized by thickening and scarring of lung tissue and is the leading cause of death among people with systemic sclerosis (SSc), also known as scleroderma. In fact, approximately 25 percent of SSc patients develop significant lung involvement within three years of diagnosis. Prior to this approval, there were no options for this patient population, making this an exciting announcement for the community.(more…)
MedicalResearch.com Interview with: Elizabeth C. Oelsner, MD, MPH Irving Assistant Professor of Medicine Division of General Medicine New York Presbyterian Columbia University MedicalResearch.com: What is the background for this study? Response: Uncertainty regarding how to diagnose chronic obstructive pulmonary disease (COPD) has posed significant problems for early detection and treatment of this common disease. Simplifying and standardizing the diagnosis of COPD has the potential to improve diagnosis, clinical care, and clinical research for this common and under-diagnosed chronic lung disease. We therefore aimed to provide robust evidence for the best threshold to diagnose COPD by comparing how well various thresholds predict hospitalizations and deaths from COPD. (more…)
MedicalResearch.com Interview with: Gerard J. Criner, MD, FACP, FACCP Chair and Professor, Thoracic Medicine and Surgery Lewis Katz School of Medicine Temple UniversityMedicalResearch.com: What is the background for this study? Response: An earlier, Phase II trial of benralizumab found a non-statistically significant reduction in COPD exacerbation rate for patients with eosinophilic inflammation in the airways. In this Phase III trial, the researchers sought to discover whether benralizumab's ability to deplete the airways of blood eosinophils in patients with eosinophilic inflammation would lead to a reduction in COPD exacerbations. The Phase III, randomized, double-blind, placebo-controlled, parallel-group clinical trials GALATHEA and TERRANOVA evaluated the efficacy and safety of benralizumab for the prevention of exacerbations in patients with moderate to very severe COPD, eosinophilic inflammation, and increased risk of exacerbations. Benralizumab is a type of drug called an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody. It is approved by the FDA for the treatment of severe eosinophilic asthma. (more…)
MedicalResearch.com Interview with: Dr. Sameer Arbat, MBBS, MD Interventional Pulmonologist at Department of Pulmonology KRIMS Hospitals, Ramdaspeth, NagpuMedicalResearch.com: What is the background for this study? What are the main findings?Response: Chronic obstructive pulmonary disease (COPD) is one of the major preventable chronic respiratory diseases. Worldwide chronic obstructive pulmonary disease (COPD) is the third leading cause of death. A retrospective data of non-smoker COPD patients coming to our tertiary health care centre-KRIMS Hospitals, India was collected from year 2016-2018. About 180 patients were found to be non-smokers who were diagnosed as COPD on their spirometry findings. Out of 180 non-smoker COPD patients, 54% were females. In our study 61% patients belonged to rural areas and 38% belonged to urban areas showing that rural region has higher majority of COPD patients than urban. Most people having this disease were housewives working on biomass wood smoke exposure and farmers working with toxic chemical sprays.(more…)
MedicalResearch.com Interview with: Judith Garcia Aymerich Head of the Non-Communicable Diseases and Environment Programme ISGlobalMedicalResearch.com: What is the background for this study? Response: Several studies have assessed the associations of overweight and obesity with lung function in children and adolescents, but they have found contradictory results. An important limitation of these studies is that most of them considered only overall body weight and did not take into account for the different contribution of lean body mass and fat mass, and their relative proportions that vary by age and sex. (more…)
MedicalResearch.com Interview with: Stephen J Ruoss MD Professor, Stanford University, Medicine, Division of Pulmonary and Cfritical Care Medicine Stanford, California MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by an atypical mycobacterial infection?Response: Our interest in undertaking this study stems from three important clinical observations and issues. First, the use of inhaled steroid medications for a broad variety of respiratory complaints and diseases is increasing, including in clinical circumstances where there isn’t much strong supportive evidence for benefit to patients from using inhaled steroids. The second observation is that steroids can and do alter immune system responses, and can increase the risk for some infections. There are already data from studying patients on inhaled steroids where the incidence of bacterial respiratory infections has increased, supporting the concerns for infection risk from inhaled steroids. And the third issue is that steroids can more specifically alter immune system function that helps combat mycobacterial infections, and this means that the risk for, and incidence of mycobacterial infections could be increased in patients treated with inhaled steroids. The best known mycobacterial infection is of course tuberculosis, but there are other mycobacteria, called nontuberculous mycobacterial (or atypical mycobacterial) that are broadly found in the environment, and some of those nontuberculous mycobacteria (NTM) can cause lung infections. So our hypothesis was that the use of inhaled steroids might be associated with an increased frequency of NTM infections, and we designed the study to explore that hypothesis. (more…)
MedicalResearch.com Interview with: Joseph Bledsoe MD, FACEP Clinical Assistant Professor of Emergency Medicine Stanford Medicine Director of Research Department of Emergency Medicine Intermountain Medical Center Murray, UT 84157 MedicalResearch.com: What is the background for this study? What are the main findings?Response: Patients with blood clots in the lungs (pulmonary embolism) (PE) are routinely admitted to the hospital for blood thinning medications in the United States. However, evidence from other countries has shown that with appropriate risk stratification patients may be safe for outpatient treatment for their PE. Our study is the largest prospective management study in the US to evaluate home treatment of patients with acute pulmonary embolism. We enrolled 200 patients and after risk stratification with the PE severity index score, leg ultrasounds and echocardiograms performed in the emergency department, patients were treated with blood thinning medications at home with routine outpatient follow up. During the 90 day follow up period we found only one patient suffered a bleeding event after a traumatic injury, without any cases of recurrent symptomatic blood clots or death. (more…)
MedicalResearch.com Interview with: Hayley B. Gershengorn, MDDivision of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Department of Medicine, Leonard M. Miller School of Medicine, University of Miami, Miami, Florida Division of Critical Care Medicine, Department of Medicine, Albert Einstein College of Medicine, Bronx, New York MedicalResearch.com: What is the background for this study? What are the main findings?Response: Beginning in December, 2011, professional guidelines have recommended against the practice of daily chest radiography (CXRs) for mechanically ventilated patients. However, we hypothesized that this practice was still commonplace in the US and varied from hospital to hospital. To address this question, we performed a retrospective cohort study of >500,000 mechanically ventilated adults across 416 US hospitals. We found that 63% of these patients received daily CXRs and that, while use has been decreasing, this decrease is small (a 3% relative reduction in the odds of daily CXR receipt per discharge quarter starting in 2012). Moreover, the hospital at which a patient received care greatly impacted the likelihood of daily CXR receipt. (more…)
MedicalResearch.com Interview with: Sara Abdallah, PhD Student, first author and Dennis Jensen, PhDAssociate Professor, Department of Kinesiology and Physical Education Associate Dean – Infrastructure, Faculty of Education Director, McGill Research Center for Physical Activity and Health Canada Research Chair in Clinical Exercise & Respiratory Physiology Associate Member, Translational Research in Respiratory Diseases Program Research Institute of the McGill University Health Center MedicalResearch.com: What is the background for this study? What are the main findings?Response: Many patients with chronic obstructive pulmonary disease (COPD) suffer from severe breathlessness at rest and on minimal exertion despite receiving optimal drug therapy for their underlying disease (e.g., bronchodilators). In these patients, breathlessness significantly diminishes exercise capacity and quality of life. Thus, research focused on identifying adjunct therapies for management of breathlessness in patients with advanced COPD is clinically relevant. A series of studies conducted in the 1970’s found that smoked cannabis caused bronchodilation (i.e., improved airway function) in healthy individuals and in patients with asthma. More recently, it has been demonstrated that delta-9 (∆9)-tetrahydrocannabinol (THC, the major cannabinoid constituent of cannabis) inhibits cholinergic contractions in isolated human bronchi and that a positive association exists between measure of lung function (e.g., forced expiratory volume in 1-sec) and cannabis use in patients with COPD. These studies lead us to hypothesize that inhalation of vaporized cannabis may alleviate exertional breathlessness and improve exercise tolerance in patients with advanced COPD by improving airway function at rest and during exercise. (more…)
MedicalResearch.com Interview with: Dr. Mikhail Kazachkov MD Director of Pediatric Pulmonology Hassenfeld Children’s Hospital NYU Langone Medical CenterMedicalResearch.com: What is the background for this study? How common is the problem of chronic cough in children? Is it more common in children with allergies, asthma or reflux?Response: Chronic cough is one of the leading causes of pediatric referrals to subspecialty physicians. Its prevalence in the general pediatric population may approach 3% (Galassi et al, Epidemiol. Prev. 2005;29,Suppl.:9–13). It is important to recognize that the main causes of chronic cough in children are completely different for those in adults. Specifically, gastroesophageal reflux and postnasal drip are not considered to be important causes of cough in children. Cough variant asthma, although is a common cause of cough in adults, does not seem to be frequently diagnosed and a cause of chronic cough in children. The main cause of chronic wet cough in children is protracted bacterial bronchitis (Chang et al, Chest. 2017 Apr;151:884-890). It is important to recognize that neurologically impaired children have completely different pathogenesis of chronic cough, which is mostly related to aspiration into the lower airway and development of aspiration-related lung disease. (more…)
MedicalResearch.com Interview with: Kenneth R. Chapman, MD MSc FRCPC FACP FCCP, FERS Director, Asthma & Airway Centre, University Health Network, Professor of Medicine, University of Toronto, GSK-CIHR Research Chair in Respiratory Health Care Delivery, Toronto, Ontario MedicalResearch.com: What is the background for this study? What are the main findings?Response: Guidelines regard inhaled bronchodilators as foundational pharmacotherapy in COPD while inhaled corticosteroids are to be used sparingly. Inhaled corticosteroids are used to reduce exacerbation tendency but come with the added risk of pneumonia, osteoporosis and other corticosteroid related adverse effects. Although only a minority of COPD patients are exacerbation prone, many patients with COPD are treated unnecessarily with inhaled corticosteroids alongside long-acting anticholinergic and beta2 agonist bronchodilators - so-called "triple therapy". In patients who have minimal exacerbation histories, inhaled corticosteroid withdrawal is suggested to reduce side-effects. Although studies have suggested this is a reasonable strategy, study limitations have been noted. The best known inhaled corticosteroid withdrawal study, the WISDOM trial, recruited only 39% of patients using triple therapy regularly before inhaled corticosteroid withdrawal; the remainder were placed on triple therapy solely for the purposes of the withdrawal study. In the SUNSET trial, long term triple therapy patients with no more than one exacerbation in the preceding year were randomized to continue triple therapy or to de-escalate to a second generation dual bronchodilator therapy - indacaterol/glycopyrronium 110/50 once daily. This one step de-escalation better mirrored clinical practice than the gradual tapering approach of the WISDOM trial. There was no increase in exacerbations after de-escalation and although average FEV1 decreased by 26 ml in the group that de-escalated, the decrease is so small as to be immeasureable in individuals. In a post-hoc analysis, a subset of patients with persistently elevated blood eosinophil counts (greater than 300 cells per uL) were the ones most likely to have exacerbations in follow-up or to have changes in FEV1.(more…)
MedicalResearch.com Interview with: Emmanuel Martinod MD PhD Assistance Publique–Hôpitaux de Paris, Hôpitaux Universitaires Paris Seine-Saint-Denis, Hôpital Avicenne, Chirurgie Thoracique et Vasculaire, Université Paris 13, Sorbonne Paris Cité, UFR Santé, Médecine et Biologie Humaine, Bobigny, Université Paris Descartes, Fondation Alain Carpentier, Laboratoire de Recherche Bio-chirurgicale, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou Paris, FranceMedicalResearch.com: What is the background for this exciting new technology and study? What are the main findings? Response:What is the background for this exciting new technology and study? What are the main findings?Response: The background is 10 years of research at laboratory followed by 10 years of academic clinical research. We demonstrated the feasability of airway bioengeenring using stented aortic matrices for complex tracheal or bronchial reconstruction.(more…)
MedicalResearch.com Interview with: Dr. Elizabeth Rhee MD Director, Infectious Disease Clinical Research MerckMedicalResearch.com: What is the background for this study? What are the main findings?Response: High-risk patients, such as the critically ill, with suspected bacterial infections require prompt treatment with appropriate empiric therapy to improve survival. Given the high prevalence of multidrug-resistant (MDR) Pseudomonas aeruginosa in the ICU setting, new safe and broadly effective treatment options are needed for critically ill patients requiring antipseudomonal agents. Ceftolozane/tazobactam (C/T) is an antipseudomonal cephalosporin/beta-lactamase inhibitor combination with broad in vitro activity against Gram-negative pathogens, including MDR P. aeruginosa and many extended-spectrum beta-lactamase (ESBL) producers. It is FDA approved for complicated intra-abdominal and urinary tract infections in adults at 1.5g (1g/0.5g) q8h. C/T is currently being studied at 3g (2g/1g) q8h, for the treatment of ventilated nosocomial pneumonia, in the ASPECT-NP Phase 3 trial. This Phase 1 pharmacokinetic (PK) study investigated the penetration of a 3g dose of C/T in the epithelial lining fluid (ELF) of ventilated patients with proven or suspected pneumonia. This is the dose and patient population being evaluated in ASPECT-NP. ELF lines the alveoli, and investigators took samples in a group of 26 patients to see what amount of C/T was in the lung and what was circulating in the plasma during the dosing intervals. In mechanically ventilated critically ill patients, the 3g dose of C/T achieved ≥50% lung penetration (relative to free plasma) and sustained levels in ELF above the target concentrations for the entire dosing interval. These findings support the 3g dose that is included in the ASPECT-NP Phase 3 trial.(more…)
MedicalResearch.com Interview with: Gustavo Nino, M.D. Children’s National Health System pulmonologist Study senior autho MedicalResearch.com: What is the background for this study? Response: The epidemiology of respiratory disorders is largely influenced by the individual’s sex resulting in overall higher risk for males than females, particularly during early life.Hormonal, anatomical and behavioral differences are postulated to play a role, but these sex-based respiratory differences are already present at birth, suggesting a strong genetic component. However, the genetic differences in the airways of males and females during early life have been remarkably understudied and are largely unknown. (more…)
MedicalResearch.com Interview with: Jinsy Andrews, MD, MS Director of Neuromuscular Clinical Trials Columbia University The Neurological Institute New York, NY 10032MedicalResearch.com: What is the background for this study? Response: The importance of respiratory function in Amyotrophic Lateral Sclerosis (ALS) has long been recognized. Despite ALS being a clinical diagnosis with variable presentation and variable rates of disease progression, all patients experience respiratory symptoms and inevitably die typically from respiratory failure. At present there is no validated biomarker of disease progression or clinical staging system. Direct measure of respiratory function in ALS is important and can be measured using vital capacity. Although the forced maneuver (FVC) has been widely used in patients with ALS, it can underestimate the actual lung capacity by causing fatigue or inducing bronchospasm in patients with ALS. More recently, the slow maneuver (SVC) has been used since it can be obtained from patients with advancing disease which can potentially minimize missing data and may reduce any underestimation of actual lung capacity due to a forceful effort. However, the prognostic value of the decline in SVC is unclear in patients with ALS. (more…)
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 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. (more…)
MedicalResearch.com Interview with: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. (more…)
MedicalResearch.com Interview with: 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. (more…)
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) 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. (more…)
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 MünchenMedicalResearch.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. (more…)
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. (more…)
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. (more…)
MedicalResearch.com Interview with: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. (more…)
MedicalResearch.com Interview with: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 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. (more…)
MedicalResearch.com Interview with: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. (more…)
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 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. (more…)
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