Author Interviews, Boehringer Ingelheim, Pulmonary Disease / 01.10.2019

MedicalResearch.com Interview with: Dr. Donald ZozDonald 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…)
AstraZeneca, Author Interviews, Pulmonary Disease / 17.09.2019

MedicalResearch.com Interview from: AstraZeneca Spokesperson MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by COPD? How common is severe COPD? Response: COPD, or chronic obstructive pulmonary disease, is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs making it hard to breathe. In the United States, COPD is the fourth leading cause of death. Its prevalence in adults 18 years of age and older is 6.5 percent. An estimated 16 million people are currently diagnosed with COPD, and millions more are believed to have it but do not know it. ETHOS is a randomized, double-blind, 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. The trial compared two doses given twice daily of PT010 (320/14.4/9.6mcg and 160/14.4/9.6mcg) with glycopyrrolate/formoterol fumarate (14.4/9.6mcg) and PT009 (320/9.6mcg), all using AEROSPHERETM Delivery Technology in a pressurized metered-dose inhaler (pMDI). Outcomes in the ETHOS trial included, as a primary endpoint, the rate of moderate or severe exacerbations. The Phase III ETHOS trial builds on the Phase III KRONOS data which together show PT010’s ability to reduce exacerbation risk in a broad range of patients with COPD, irrespective of whether they have had an exacerbation in the previous twelve months. (more…)
Author Interviews, Flu - Influenza, Pulmonary Disease, Stem Cells, University of Pennsylvania / 22.08.2019

MedicalResearch.com Interview with: Andrew E. Vaughan, PhD Assistant Professor, Biomedical Sciences School of Veterinary Medicine University of Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: Severe respiratory infections, including influenza, can progress to acute respiratory distress syndrome (ARDS), wherein barrier function and gas exchange are compromised.  It’s a very life threatening scenario.  This is due in part to loss of alveolar type 2 (surfactant producing) and type 1 cells (gas exchanging).  Interestingly alveolar type 2 cells are also stem cells in the lung.  We wondered whether transplant of these cells might aid in recovery from severe influenza infection, and sure enough, it did! (more…)
Author Interviews, Environmental Risks, JAMA, NIH, Pulmonary Disease / 13.08.2019

MedicalResearch.com Interview with: Joel Kaufman, MD, MPH, Professor   Environmental & Occupational Health Sciences, Medicine, and Epidemiology University of Washington  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Increasingly, it is recognized that chronic lung diseases like emphysema occur in nonsmokers and rates of these diseases are continuing to increase.  We really need to understand what’s causing chronic lung disease. Air pollutants are known to make disease worse in people with prior lung disease, but little is known about whether long-term exposure to air pollutants can cause chronic lung disease. We found that higher residential concentrations of air pollutants—especially ozone and traffic-related air pollutants—are associated with changes in the lung—emphysema-like changes in the lung.  The associations were strong and suggest that air pollution may be an important contributor to chronic lung disease.  (more…)
Author Interviews, Biomarkers, NEJM, Pulmonary Disease / 11.07.2019

MedicalResearch.com Interview with: Dr. Chris Butler,, BA MBChB DCH CCH MD FRCGP (Hon)FFPH FMedSci Professor of Primary Care Nuffield Department of Primary Care Health Sciences, Professorial Fellow at Trinity College Clinical Director Primary Care Clinical Trials Unit University of Oxford  MedicalResearch.com: What is the background for this study? Response: More than a million people in the UK have COPD, which is a lung condition associated with smoking and other environmental pollutants. People living with the condition often experience exacerbations, or flare-ups, and when this happens, three out of four are prescribed antibiotics. However, two-thirds of these flare-ups are not caused by bacterial infections and antibiotics often do not benefit patients. A simple finger-prick blood test could help prevent unnecessary prescribing of antibiotics for people with the lung condition chronic obstructive pulmonary disease (COPD).  The finger-prick test measures the amount of C- reactive protein (CRP) - a marker of inflammation that rises rapidly in the blood in response to serious infections. People with a COPD flare-up who have a low CRP level in the blood appear to receive little benefit from antibiotic treatment. The General Practitioner (GP) use of a C-Reactive Protein (CRP) Point of Care Test (POCT) to help target antibiotic prescribing to patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) who are most likely to benefit (The PACE Study) determined whether the using a POCT CRP to guide antibiotic treatment decisions for acute exacerbations of COPD reduced antibiotic use without harming patients. (more…)
Author Interviews, Columbia, JAMA, Pulmonary Disease / 28.06.2019

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…)
Author Interviews, Boehringer Ingelheim, NEJM, Pharmaceutical Companies, Pulmonary Disease / 30.05.2019

MedicalResearch.com Interview with: Donald Zoz, M.D., Senior associate director Clinical Development & Medical Affairs Boehringer Ingelheim Pharmaceuticals, Inc. MedicalResearch.com: What is the background for this study? How does nintedanib differ from other treatments for SSc-ILD? What are the main findings?  Response: SENSCIS is a Phase III double-blind, randomized placebo-controlled trial that included 576 patients in 32 countries. It is the largest trial to have been conducted in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD). The primary endpoint was the annual rate of decline in forced vital capacity (FVC) over 52 weeks. At the end of the 52-week trial, patients receiving nintedanib had an adjusted annual rate of decline in FVC (mL/year) of -52.4 with nintedanib versus -93.3 with placebo (absolute difference 41.0mL/year [95% CI 2.9, 79.0]; p=0.04). This corresponds to a relative difference of 44% reduction in lung function decline. There are currently no approved treatments for SSc-ILD., BI conducted the SENSCIS study to evaluate in SSc-ILD patients the impact of nintedanib. Nintedanib, a selective tyrosine kinase inhibitor, is an antifibrotic agent. Results of the study, which were published in The New England Journal of Medicine and presented at the American Thoracic Society (ATS) International Conference, showed that nintedanib slowed the loss of pulmonary function by 44% in patients with SSc-ILD relative to placebo, as measured by FVC over 52 weeks.  (more…)
Author Interviews, Immunotherapy, NEJM, Pulmonary Disease / 22.05.2019

MedicalResearch.com Interview with: Gerard J. Criner, MD, FACP, FACCP Chair and Professor, Thoracic Medicine and Surgery Lewis Katz School of Medicine Temple University  MedicalResearch.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…)
Author Interviews, Heart Disease, JAMA, Johns Hopkins, Pulmonary Disease / 07.05.2019

MedicalResearch.com Interview with: Robert A. Wise, M.D. Professor of Medicine Pulmonary and Critical Care Johns Hopkins University School of Medicine Baltimore, MD MedicalResearch.com: What is the background for this study? What are the main findings? Response: There has been a lingering controversy about the safety of long-acting anti-muscarinic agents (LAMA) as maintenance treatment for COPD in patients who have increased cardiovascular risk.  This study enrolled participants with COPD who also had increased cardiovascular risk or known cardiovascular disease.  Participants were randomly treated with either aclidinium bromide (Tudorza Pressair) or placebo. Over 3 years of follow up there was no increased risk of adverse cardiovascular events.  Moreover, the medication had a significant benefit in terms of reducing exacerbations and COPD hospitalizations. (more…)
Author Interviews, Pulmonary Disease / 16.04.2019

MedicalResearch.com Interview with: Dr. Sameer Arbat, MBBS, MD Interventional Pulmonologist at Department of Pulmonology KRIMS Hospitals, Ramdaspeth, Nagpu  MedicalResearch.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…)
Author Interviews, Biomarkers, Johns Hopkins, NIH, Pulmonary Disease, Transplantation / 29.01.2019

MedicalResearch.com Interview with: Sean Agbor-Enoh, M.D., Ph.D. Co-Director/Staff Clinician Laboratory of Transplantation Genomics National Heart, Lung, and Blood Institute National Institutes of Health MedicalResearch.com: What is the background for this study? Response: People who receive organ transplants may develop acute or chronic rejection, in which the body’s immune system attacks the transplanted organ. While acute rejection is treatable and reversible, chronic rejection is not and remains the most common cause for organ transplant loss. Lung transplant recipients have the shortest survival rates among patients who get solid organ transplantation of any kind—only about half live past five years. This poor survival rate among lung transplant recipients is due in part to a high incidence of chronic rejection. Existing tools for detecting signs of rejection, such as biopsy, either require the removal of small amounts of lung tissue or are not sensitive enough to discern the severity of the rejection. Building upon earlier work, our research team developed a simple blood test that can detect when a newly transplanted lung is being rejected by a patient, even when no outward signs of the rejection are evident.  The test could make it possible for doctors to intervene faster to prevent or slow down so-called chronic rejection—which is severe, irreversible, and often deadly—in those first critical months after lung transplantation. This same test might also be useful for monitoring rejection in other types of organ transplants. Called the donor-derived cell-free DNA test, the experimental test begins with obtaining a few blood droplets taken from the arm of the transplant recipient. A special set of machines then sorts the DNA fragments in the blood sample, and in combination with computer analysis, determines whether the fragments are from the recipient or the donor and how many of each type are present.  Because injured or dying cells from the donor release lots of donor DNA fragments into the bloodstream compared to normal donor cells, higher amounts of donor DNA indicate a higher risk for transplant rejection in the recipient. (more…)
Author Interviews, Global Health, Pediatrics, Pulmonary Disease, Weight Research / 12.01.2019

MedicalResearch.com Interview with: Judith Garcia Aymerich Head of the Non-Communicable Diseases and Environment Programme ISGlobal  MedicalResearch.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…)
Asthma, AstraZeneca, Author Interviews, Pulmonary Disease / 22.11.2018

MedicalResearch.com Interview with: “Asthma Inhaler” by NIAID is licensed under CC BY 2.0Sean O'Quinn MPH Director, Patient Reported Outcomes AstraZeneca  MedicalResearch.com: What is the background for this study? How does benralizumab differ from traditional medications for asthma? Response:  FASENRA™ (benralizumab 30mg for subcutaneous injection as add-on maintenance therapy in severe eosinophilic asthma for patients 12 years and older) has a strong clinical profile, including powerful efficacy against exacerbations and the ability to improve lung function. Benralizumab is a respiratory biologic that binds directly to the IL-5α receptor on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis. (NOTE: The mechanism of action of FASENRA in asthma has not been definitively established.) Benralizumab is not indicated for treatment of other eosinophilic conditions or for relief of acute bronchospasm or status asthmaticus. The most common adverse reactions include headache and pharyngitis. Dependence on rescue medications is indicative of poor asthma control. In the Phase III SIROCCO/CALIMA trials, patients with severe eosinophilic asthma had significantly reduced exacerbation frequency and improved lung function when treated with benralizumab 30mg Q8W (first three doses Q4W) vs. placebo. Less was known about the effects of benralizumab on rescue medication usage—specifically daily total rescue medication use, daytime and nighttime rescue medication use, and nighttime awakenings requiring rescue medication use. The aim of this analysis was to understand the potential treatment effects of benralizumab on these parameters.  (more…)
Annals Internal Medicine, Author Interviews, Blood Clots, Emergency Care, Kaiser Permanente, Pulmonary Disease, UC Davis / 13.11.2018

MedicalResearch.com Interview with: David R. Vinson, MD Department of Emergency Medicine Kaiser Permanente Sacramento Medical Center Sacramento, CA MedicalResearch.com: What is the background for this study? What are the main findings? Response: At least one-third of emergency department (ED) patients with acute blood clots in the lung, or pulmonary embolism (PE), are eligible for expedited discharged to home, either directly from the ED or after a short (<24 hour) period of observation. Yet in in most hospitals in the U.S. and around the world nearly all ED patients with acute PE are hospitalized. These unnecessary hospitalizations are a poor use of health care resources, tie up inpatient beds, and expose patients to the cost, inconvenience, and risk of inpatient care. The better-performing medical centers have two characteristics in common: they help their physicians identify which PE patients are candidates for outpatient care and they facilitate timely post-discharge follow-up. At Kaiser Permanente Northern California (KPNC), we have had the follow-up system in place for some time, but didn’t have a way to help our physicians sort out which patients with acute PE would benefit from home management. To correct this, we designed a secure, web-based clinical decision support system that was integrated with the electronic health record. When activated, it presented to the emergency physician the validated PE Severity Index, which uses patient demographics, vital signs, examination findings, and past medical history to classify patients into different risk strata, correlated with eligibility for home care. To make use of the PE Severity Index easier and more streamlined for the physician, the tool drew in information from the patient’s comprehensive medical records to accurately auto-populate the PE Severity Index. The tool then calculated for the physician the patient’s risk score and estimated 30-day mortality, and also offered a site-of-care recommendation, for example, “outpatient management is often possible.” The tool also reminded the physician of relative contraindications to outpatient management. At the time, only 10 EDs in KPNC had an on-site physician researcher, who for this study served as physician educator, study promotor, and enrollment auditor to provide physician-specific feedback. These 10 EDs functioned as the intervention sites, while the other 11 EDs within KPNC served as concurrent controls. Our primary outcome was the percentage of eligible ED patients with acute PE who had an expedited discharge to home, as defined above. During the 16-month study period (8-month pre-intervention and 8-months post-intervention), we cared for 1,703 eligible ED patients with acute PE. Adjusted home discharge increased at intervention sites from 17% to 28%, a greater than 60% relative increase. There were no changes in home discharge observed at the control sites (about 15% throughout the 16-month study). The increase in home discharge was not associated with an increase in short-term return visits or major complications.  (more…)
Author Interviews, Infections, Pediatrics, Pulmonary Disease / 08.11.2018

MedicalResearch.com Interview with: Andrea Hahn, M.D., MS Infectious disease specialist and lead study author Children's National Health System MedicalResearch.com: What is the background for this study? What are the main findings? Response: People who have the genetic disease cystic fibrosis have increased sticky secretions in their lungs that put them at risk for repeated bacterial infections. They often will receive courses of intravenous antibiotics to treat more severe or difficult-to-treat infections associated with decreased lung function. However, not all patients fully recover their lung function after antibiotic treatment, despite directing antibiotic therapy toward the specific bacteria thought to be causing the infection. The goal of this study was to determine if the pharmacokinetics of commonly used antibiotics was associated with recovery of lung function. First, we found that patients with therapeutic blood levels of beta-lactam antibiotics had better lung recovery than patients with sub-therapeutic levels of these antibiotics. Second, we found that using higher antibiotic dosing according to Cystic Fibrosis Foundation guidelines was not sufficient to predict which patients would have therapeutically meaningful blood levels of antibiotics. (more…)
Author Interviews, Genetic Research, NEJM, Pulmonary Disease, Rheumatology / 24.10.2018

MedicalResearch.com Interview with: Joyce S. Lee, MD Associate Professor Director, Interstitial Lung Disease Program Department of Medicine Division of Pulmonary Sciences and Critical Care Medicine University of Colorado School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Rheumatoid arthritis (RA) is a common inflammatory arthritis that can be complicated by interstitial lung disease (ILD). Patients with RA-ILD share clinical characteristics with another ILD called idiopathic pulmonary fibrosis (IPF). Given the similar clinical phenotype, our goal was to see if these lung diseases (IPF and RA-ILD) shared a common genetic risk factor. The MUC5B promoter variant is the most common risk factor (genetic and otherwise) for the development of IPF. Our findings demonstrate the MUC5B promoter variant is also a strong risk factor for the development of RA-ILD among patients with RA. (more…)
Author Interviews, Hand Washing, Infections, Pulmonary Disease, Respiratory / 16.10.2018

MedicalResearch.com Interview with: "still picking her nose" by quinn norton is licensed under CC BY 2.0Dr Victoria Connor  Clinical Research Fellow Liverpool School of Tropical Medicine and Royal Liverpool Hospital  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Pneumococcus is a bacteria which is very common and causes lots of different infections (pneumococcal disease). Infections can be non-invasive or invasive. Non-invasive diseases include middle ear infections, sinusitis and bronchitis. Invasive infections including chest infection (pneumonia), infections of brain and spinal cord (meningitis) and blood infections (sepsis). Invasive pneumococcal infections is a major cause of death around the world and in the UK, is estimated that is responsible for 1.3 million deaths in children under 5 annually. Pneumococcal disease causes more deaths in low and middle income countries where approximately 90% of pneumonia deaths occur. Pneumococcus also is commonly carried (colonises) the nose/throat of children and adults. This colonisation is important to understand as it is the main source of the bacterial transmission and is also the first step in pneumococcal infections. The understanding of transmission of pneumococcus is currently poor. It is generally thought that transmission occurs through breathing in the respiratory sections of someone carrying pneumococcus in their nose which are infected with pneumococcus. However more recently studies especially in mice have shown that there may be a role of hands or other objects as vehicles for the transmission of pneumococcus. (more…)
Asthma, AstraZeneca, Author Interviews, Pulmonary Disease / 20.09.2018

MedicalResearch.com Interview with: Tosh Butt, MBA VP Respiratory AstraZeneca MedicalResearch.com: What is the background for this study? How is benralizumab different from more traditional treatments for asthma?
    • BORA is a randomized, double-blind, parallel-group, Phase III extension, and is one of six Phase III trials in the WINDWARD program in asthma. The current analysis includes results for 1,926 patients from the two placebo controlled exacerbation trials, SIROCCO (48 week) and CALIMA (56 weeks). BORA provides evidence that add on maintenance treatment with FASENRA (benralizumab) resulted in a consistent safety profile over a second year of treatment, with no increase in the frequencies of overall or serious adverse events, and sustained efficacy in terms of reducing asthma exacerbations, and improving lung function and asthma symptoms. The BORA trial results could provide confidence to patients with severe eosinophilic asthma and physicians that the positive outcomes they may be seeing with benralizumab can be maintained over a second year of treatment.
  • FASENRA, a different kind of respiratory biologic, has a strong clinical profile which includes the ability to show lung function improvement after the first dose, the potential to reduce – or even stop - oral steroid use, and the convenience of 8-week dosing (no other respiratory biologic offers this dosing). FASENRA is approved for add-on maintenance treatment of patients with severe asthma ages 12 years and older, and with an eosinophilic phenotype. FASENRA binds directly to the IL-5a receptor on an eosinophil and uniquely attracts natural killer cells to induce apoptosis, or cell death. Other biologics currently available are anti-IL5s – a passive approach that primarily acts to block differentiation and survival of the eosinophil.
(more…)
Author Interviews, Infections, Pulmonary Disease, Stanford / 15.09.2018

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…)
Author Interviews, Pediatrics, Pulmonary Disease, Tobacco Research / 18.08.2018

MedicalResearch.com Interview with: “#smoke” by Seniju is licensed under CC BY 2.0Ryan Diver MSPH Director, Data Analysis American Cancer Society, Inc. 250 Williams St. Atlanta, GA 30303 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Secondhand smoke is known to have adverse effects on the lung and vascular systems in both children and adults. But it is unknown whether childhood exposure to secondhand smoke is associated with mortality in adulthood. To explore the issue, we examined associations of childhood and adult secondhand smoke exposure with death from all causes, ischemic heart disease, stroke, and chronic obstructive pulmonary disease among 70,900 never-smoking men and women from the Cancer Prevention Study II Nutrition Cohort. Study participants, primarily ages 50 to 74 at the beginning of the study, answered questions about their secondhand smoke exposure during childhood and as adults and were followed for 22 years. Those who reported having lived with a daily smoker throughout their childhood had 31% higher mortality from chronic obstructive pulmonary disease compared to those who did not live with a smoker. Although the study counted only deaths, the increase in fatal COPD implies that living with a smoker during childhood could also increase risk of non-fatal COPD. In addition, secondhand smoke exposure (10 or more hours/week) as an adult was associated with a 9% higher risk of all-cause mortality, a 27% higher risk of death from ischemic heart disease, a 23% higher risk of death from stroke, and a 42% higher risk of death from COPD. (more…)
Author Interviews, Clots - Coagulation, Emergency Care, Pulmonary Disease, Stanford / 18.08.2018

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…)
Author Interviews, Critical Care - Intensive Care - ICUs, JAMA, Pulmonary Disease / 15.08.2018

MedicalResearch.com Interview with: Hayley B. Gershengorn, MD Division 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…)
Author Interviews, Cannabis, McGill, Pulmonary Disease / 30.07.2018

MedicalResearch.com Interview with: Sara Abdallah, PhD Student, first author and Dennis Jensen, PhD Associate 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…)
Author Interviews, Biomarkers, NYU, Pediatrics, Pulmonary Disease / 29.07.2018

MedicalResearch.com Interview with: Dr. Mikhail Kazachkov MD Director of Pediatric Pulmonology Hassenfeld Children’s Hospital NYU Langone Medical Center  MedicalResearch.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…)
Antioxidants, Author Interviews, Nutrition, Pulmonary Disease, Supplements / 18.07.2018

MedicalResearch.com Interview with: Scott D Sagel MD PhD Professor of Pediatrics University of Colorado School of Medicine Aurora, Colorado MedicalResearch.com: What is the background for this study? Response: Inflammation is an important feature of cystic fibrosis (CF) lung disease and contributes to lung damage and lung function decline in CF. We need safe and effective anti-inflammatory treatments in CF. Anti-oxidant therapy has been an area of promise, but with mixed results in CF. This clinical trial, conducted at 15 CF centers affiliated with the cystic fibrosis Foundation Therapeutics Development Network, enrolled 73 patients who were 10 years and older (average age 22 years), with pancreatic insufficiency, which causes malabsorption of antioxidants. Subjects were randomized to either a multivitamin containing multiple antioxidants including carotenoids such as beta(β)-carotene, tocopherols (vitamin E), coenzyme Q10 (CoQ10), and selenium or to a control multivitamin without antioxidant enrichment. The antioxidants used in the study were delivered in a capsule specifically designed for individuals with difficulties absorbing fats and proteins, including those with cystic fibrosis. (more…)
Asthma, AstraZeneca, Author Interviews, Immunotherapy, Lancet, Pulmonary Disease / 27.06.2018

MedicalResearch.com Interview with: Reynold A. Panettieri, Jr., M.D. Professor of Medicine, Robert Wood Johnson Medical School Vice Chancellor, Clinical & Translational Science Director, Rutgers Institute for Translational Medicine & Science Emeritus Professor of Medicine, University of Pennsylvania Child Health Institute of New Jersey Rutgers, The State University of New Jersey New Brunswick, NJ  08901 MedicalResearch.com: What is the background for this study? Response: Severe asthma is characterized by Type 2 inflammation manifested by increases in IL-13, IL-4 and Il-5 levels in the airways that promotes airway hyperresponsiveness and in part irreversible airway obstruction.  These clinical manifestations profoundly increase asthma morbidity and mortality. To address an unmet therapeutic need, Tralokinumab was developed as a monoclonal antibody targeting soluble IL-13 with the goal of improving lung function and patient reported outcomes while decreasing annual exacerbation rates.  Stratus 1 and 2 represent two identical randomized, double-blind, placebo-controlled, phase 3 clinical trials in severe asthma.  These international trials enrolled approximately 2000 subjects with severe asthma and examined whether Tralokinumab decreased annualized exacerbation rates (AER) as compared with placebo (primary outcome). (more…)
Author Interviews, Boehringer Ingelheim, Pulmonary Disease / 05.06.2018

MedicalResearch.com Interview with: Christopher J. Ryerson, M.D. Assistant Professor Centre for Heart Lung Innovation University of British Columbia Vancouver, Canada MedicalResearch.com: What is the background for this study? What are the main findings? Response: A new Idiopathic pulmonary fibrosis (IPF) mortality analysis presented at the American Thoracic Society’s 2018 annual conference suggests that treatment with nintedanib may be associated with reduced risk of death in patients with the rare lung disease idiopathic pulmonary fibrosis (IPF). Pooled data from the two Phase II INPULSIS trials and the Phase II TOMORROW study compared the number of deaths observed versus the number predicted based on GAP stage over one year. GAP stage is used to predict IPF prognosis and is based on gender, age and lung function (as measured by forced vital capacity [FVC] decline predicted and DLco % predicted). Higher stages of GAP are associated with an increased risk of death. Across the population in the analysis (n=1,228), there were fewer deaths observed in each treatment group than predicted based on GAP stage at baseline (nintedanib: 42 vs. 89.9; placebo: 41 vs. 64.2). In the treated group, the number of observed deaths was 46.7% of the number predicted based on GAP stage, while in the placebo group the number of observed deaths was 63.9% of the number predicted. Based on these observations, the analysis suggests that nintedanib may be associated with a 26.8% relative reduction in the risk of death compared with placebo over one year.  (more…)
Anesthesiology, Author Interviews, Pulmonary Disease / 03.06.2018

MedicalResearch.com Interview with: Dr James Purcell University College Cork and South Infirmary Victoria University Hospital Cork, Ireland MedicalResearch.com: What is the background for this study? Response: Nail varnish and acrylic nails are common accessories and as such are commonly encountered by an array of healthcare professionals in various scenarios when SpO2 readings may be part of patient care.. Colloquially there was a wide variety of approaches and beliefs as to whether or not these treatments impacted on SpO2 readings. This is due to the fact that the Digital Pulse oximetry relies on the passing of a wavelength of light through a pulsatile nailbed to a sensor on the opposite side of the finger tip in order to read SpO2 levels. Any potential interference to this process by polish of certain hues, or acrylic was therefor believed to impact on the resultant readings As such it was decided to analyse the actual level of knowledge and variety of approaches to the issue by means of a multisite study involving Consultants, NCHDs, and nursing staff in areas where this issue may arise. A second, experimental part of the study was set up using healthy volunteers and venous congestion and hypoxia modelling. Nail varnish of differing hues and acrylic nails were applied and results of SpO2 readout in healthy and pathological models with and without nail treatments applies were analysed. (more…)
Author Interviews, Connective Tissue Disease, Pulmonary Disease / 29.05.2018

MedicalResearch.com Interview with: Pierre Laurin, CEO Prometic Life Sciences MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by idiopathic pulmonary fibrosis? Response: Idiopathic pulmonary fibrosis (IPF) is a chronic, devastating, and ultimately fatal disease characterized by a progressive decline in lung function. It is a specific type of interstitial lung disease in which the small air sacs of the lung, the “alveoli,” gradually become replaced by fibrotic (scar) tissue and is the cause of worsening dyspnea (shortness of breath). The 5-year mortality rate for patients with IPF is estimated to range from 50% to 70%. Small molecule candidate PBI-4050’s anti-fibrotic activity has been observed in various fibrosis models in different organs: lung, kidney, heart, liver, and pancreas. PBI-4050 has been shown to improve forced vital capacity (FVC) in an open-label Phase 2 study in IPF. The main objective of this exploratory study was to determine whether treatment with PBI-4050 alters the level of key biomarkers in patients with IPF. Subjects with a confirmed diagnosis of IPF received daily oral doses of 800 mg PBI-4050 with or without nintedanib or pirfenidone for 12 weeks. The biomarkers chosen for measurement can be divided into two main groups: cytokines and matrix metalloproteinases associated with fibrosis and inflammation. (more…)
Author Interviews, Pulmonary Disease / 29.05.2018

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…)