Antioxidants, Author Interviews, Nutrition, Pulmonary Disease, Supplements / 18.07.2018

MedicalResearch.com Interview with: [caption id="attachment_43251" align="alignleft" width="144"]Scott D Sagel MD PhD Professor of Pediatrics University of Colorado School of Medicine Aurora, Colorado Dr. Sagel[/caption] 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.
Asthma, AstraZeneca, Author Interviews, Immunotherapy, Lancet, Pulmonary Disease / 27.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42814" align="alignleft" width="141"]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 Dr. Panettieri[/caption] 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).
Author Interviews, Boehringer Ingelheim, Pulmonary Disease / 05.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42182" align="alignleft" width="143"]Christopher J. Ryerson, M.D. Assistant Professor Centre for Heart Lung Innovation University of British Columbia Vancouver, Canada Dr. Ryerson[/caption] 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. 
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  or newer trends like magnetic gel polish 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 (magnetic nails were not studied) were applied and results of SpO2 readout in healthy and pathological models with and without nail treatments applies were analysed.
Author Interviews, Connective Tissue Disease, Pulmonary Disease / 29.05.2018

MedicalResearch.com Interview with: [caption id="attachment_41845" align="alignleft" width="125"]Pierre Laurin, CEO Prometic Pierre Laurin[/caption] 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.
Author Interviews, Pulmonary Disease / 29.05.2018

MedicalResearch.com Interview with: [caption id="attachment_42008" align="alignleft" width="149"]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 Dr. Chapman[/caption] 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. 
Author Interviews, JAMA, Pulmonary Disease, Stem Cells, Transplantation / 21.05.2018

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, France  MedicalResearch.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. 
Author Interviews, Global Health, JAMA, Pulmonary Disease, Technology / 15.05.2018

MedicalResearch.com Interview with: [caption id="attachment_41623" align="alignleft" width="200"]Michael Hawkes MD PhD Adjunct Professor Assistant Professor  Pediatrics, Faculty of Medicine School of Public Health University of Alberta Dr. Hawkes[/caption] Michael Hawkes MD PhD Adjunct Professor Assistant Professor Pediatrics, Faculty of Medicine School of Public Health University of Alberta MedicalResearch.com: What is the background for this study? What are the main findings?
  • Pneumonia is the leading cause of mortality in children globally.
  • Oxygen is an essential therapy for children with hypoxemic pneumonia, but is not available in many resource-limited and rural areas.
  • Our innovation, solar powered oxygen delivery, harnesses freely available sun and air to delivery oxygen to patients independent of grid electricity.
  • We performed a randomized controlled trial of solar powered oxygen delivery, compared to standard oxygen delivery using compressed oxygen cylinders in children with hypoxemia hospitalized at two centres in Uganda.
  • Solar powered oxygen was non-inferior to cylinder oxygen with respect to clinical outcomes, and offers advantages in terms of reliability, simplicity, and cost.
Author Interviews, Pediatrics, Pulmonary Disease / 15.04.2018

MedicalResearch.com Interview with: [caption id="attachment_41190" align="alignleft" width="135"]Gustavo Nino, M.D. Children’s National Health System pulmonologist Study senior author Dr. Nino Barrera[/caption] 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.
Author Interviews, Boehringer Ingelheim, FDA, Pulmonary Disease, Rheumatology / 03.04.2018

MedicalResearch.com Interview with: [caption id="attachment_40947" align="alignleft" width="167"]Dr. Thomas Leonard, Ph.D. Executive director, Clinical Development and Medical Affairs, Specialty Care Boehringer Ingelheim Pharmaceuticals, Inc. Dr. Thomas Leonard[/caption] Dr. Thomas Leonard, Ph.D. Executive director, Clinical Development and Medical Affairs, Specialty Care Boehringer Ingelheim MedicalResearch.com: What is the background for this announcement? Would you briefly explain what is meant by systemic sclerosis? What are the disease symptoms and manifestations? Response: The FDA recently granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with interstitial lung disease (SSc-ILD) – paving the way for Boehringer Ingelheim to take an important step in advancing this potential therapy for those affected by this disease. The designation was based on Boehringer Ingelheim’s Investigational New Drug application (IND) and the anticipated efficacy and safety data from SENSCIS™ (Safety and Efficacy of Nintedanib in Systemic SClerosIS), a double-blind, randomized, placebo-controlled global Phase III trial which is fully enrolled and includes more than 520 patients from 32 countries. The FDA’s Fast Track designation facilitates the development of new therapies that treat serious conditions and fulfill an unmet medical need in an effort to get treatments to those in need sooner, like those living with systemic sclerosis. Systemic sclerosis, also known as scleroderma, is a rare disease characterized by thickening and scarring of connective tissue of multiple organs in the body, typically affecting women between ages 25 and 55. Most people with the disease will develop some degree of lung scarring, or interstitial lung disease (ILD), which is the leading cause of death among people with systemic sclerosis. Nintedanib, currently marketed as Ofev®, is approved for treatment of a rare lung disease called idiopathic pulmonary fibrosis, or IPF, and has been shown to slow disease progression as measured by annual rate of decline in lung function. Because SSc-ILD and IPF share similarities in how the underlying lung scarring, or fibrosis, forms in people with the disease, Boehringer Ingelheim is evaluating the impact of nintedanib on SSc-ILD.
Asthma, Author Interviews, NEJM, Pulmonary Disease / 09.03.2018

MedicalResearch.com Interview with: “Asthma Inhaler” by NIAID is licensed under CC BY 2.0Timothy Harrison, MBBS, BSc, FRCP, MD, MSc Professor and Honorary Consultant Faculty of Medicine & Health Sciences University of Nottingham MedicalResearch.com: What is the background for this study? What are the main findings? Response: Self management plans are recommend for patients with asthma but previous studies have shown that doubling the dose of inhaled steroids when asthma starts deteriorating is ineffective at preventing the development of an exacerbation. This study shows that quadrupling the dose is effective and in a real-life setting can reduce severe exacerbations by about 20%
Author Interviews, Boehringer Ingelheim, Dermatology, Pulmonary Disease, Rheumatology / 05.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40385" align="alignleft" width="200"]Donald Zoz, MD Senior Associate Director Clinical Development & Medical Affairs IPF/ILD Boehringer Ingelheim Pharmaceuticals, Inc. Dr. Zoz[/caption] Donald Zoz, MD Senior Associate Director Clinical Development & Medical Affairs IPF/ILD Boehringer Ingelheim Pharmaceuticals, Inc. MedicalResearch.com: What is the background for this platform? Would you briefly explain what is meant by scleroderma? How does it affect a person's skin and ability to function? Whom does this disease primarily affect? Response: “More Than Scleroderma™: The Inside Story” is Boehringer Ingelheim’s new global initiative highlighting real-life, inspirational stories of people living with the rare disease scleroderma. The new effort, created with support from the Scleroderma Foundation in the U.S., aims to raise awareness of the disease, dispel misperceptions and provide important resources to support and guide those on their journey with scleroderma. The initiative’s website http://www.morethanscleroderma.com/us/ features a powerful and inspiring collection of diverse photographs and video profiles of 10 people across the U.S. living with scleroderma and sharing their ‘inside story.’ Each tells their unique and moving experience with scleroderma through diagnosis to learning to live with the disease and manage it. Many less fortunate people in developing countries have to deal with this on a daily basis and only have the support of Orphan Drug Distributors and charities and I'm so thankful that people like this are available to support these people! Scleroderma, also known as systemic sclerosis, is a rare disease characterized by thickening and scarring of the skin, lungs and other organs. Scleroderma affects fewer than 200,000 people in the U.S. and typically affects women in the prime of their lives, between the ages of 25 and 55 taking a marked toll just as they are building their careers and bearing the responsibility of caring for their family. Nearly all people with scleroderma (more than 90%) will develop some skin symptoms including skin thickening, tightened skin around the joints, small red spots on the face and hands and hard lumps on pressure points and joints. Most people with the disease will also develop some degree of lung scarring, or interstitial lung disease (ILD). When the disease's signature thickening and scarring develops in vital organs, such as the lungs, there are potentially debilitating and life-threatening consequences.
Author Interviews, Emergency Care, JAMA, Pulmonary Disease / 31.01.2018

MedicalResearch.com Interview with: Giorgio Costantino MD Dipartimento di Medicina Interna Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca’ Granda Ospedale Maggiore Policlinico Università degli Studi di Milano Milan, Italy MedicalResearch.com: What is the background for this study? Response: Syncope is a common symptom that occurs in one in four people during their lifetime. Pulmonary embolism (PE) has long been recognized as an important and serious cause of syncope. PE has always been estimated a rare cause of syncope, present in less than 1.5% of patients. A recent study (PESIT), aiming at evaluating PE prevalence using a standardized algorithm in hospitalized patients after a first syncope episode, found a prevalence of PE as high as 17% in hospitalized patients. This means that patients with a first episode of syncope should be investigated with a standard diagnostic algorithm to exclude PE. However, many patients might go through useless and potentially harmful tests, such as computed tomography pulmonary angiogram.
Author Interviews, BMJ, Pulmonary Disease, Surgical Research / 25.01.2018

MedicalResearch.com Interview with: Ianthe Boden Titled Cardiorespiratory APAM, PhD Candidate, MSc, BAppSc Manager Abdominal Surgery Research Group Clinical Lead – Cardiorespiratory Physiotherapy, Physiotherapy Department Allied Health Services Tasmanian Health Services – North | Launceston General Hospital Launceston TA  MedicalResearch.com: What is the background for this study? Response: Major upper abdominal surgery involves opening up the abdomen - mainly to remove cancer or damaged bowel, liver, stomach, pancreas, or kidney.  It is, by far, the most common major surgical procedure performed in developed countries with millions of procedures performed per annum. Unfortunately a respiratory complication following these operations occurs relatively frequently with between 1 in 10 to almost a half of all patients getting some type of respiratory complication after surgery. Respiratory complications included problems such as pneumonia, lung collapse, respiratory failure, and an acute asthma attack. These complications, especially pneumonia and respiratory failure, are strongly associated with significant morbidity, mortality, increased antibiotic usage and longer hospital stay. These breathing problems occur quite quickly after surgery, becoming evident usually within the first two to three days after surgery. In an effort to ameliorate these complications in developed countries it is common for physiotherapists/respiratory therapists to see a patient for the first time on the day after surgery and start patients doing breathing exercises. However as respiratory dysfunction starts occurring immediately following surgery it is debated that these breathing exercises are being provided too late. Initiating prophylactic treatment more than 24 hours after the end of surgery may not be as effective as starting prophylaxis immediately. Unfortunately, immediately after surgery patients are either very sleepy, in pain, feeling sick, or delirious. It may not be possible to effectively teach patients at this point on the importance of breathing exercises and get good performance. One method to overcome this would be to meet patients before the operation to educate them about their risk of a postoperative chest infection and to motivate and train them to perform breathing exercises to do immediately on waking from surgery. Previous trials have indicated that this may help prevent postoperative respiratory complications, although evidence is inconclusive and weak. We set out to robustly and conclusively see if respiratory complications could be prevented after major upper abdominal surgery if patients were taught breathing exercises to do as soon as they woke up after the operation. We ran this trial in two countries (Australia and New Zealand) and three different types of hospitals.  All patients were met by a physiotherapist at our hospitals’ scheduled pre-admission clinic appointment and either provided with an information booklet (control) or provided with an additional 30 minute education and training session with the physiotherapist. At this preoperative session the patient was educated about respiratory complications, their risk, and how to prevent them with breathing exercises. These exercises were then taught and practiced for just three repetitions. Patients were instructed to do these breathing exercises for 20 repetitions as soon as they woke from surgery and then 20 times every hour after surgery until they were up and out of bed frequently. Following surgery each patient had a standardised rehabilitation program and no respiratory therapy of any type was provided to the patients after surgery. For the first two weeks after surgery patients were assessed daily for a respiratory complication by research assistants unaware of what treatment the patient had received before surgery.
Author Interviews, Primary Care, Pulmonary Disease / 15.12.2017

MedicalResearch.com Interview with: [caption id="attachment_38964" align="alignleft" width="107"]Dr Jennifer K Quint MSc PhD FHEA FRCP Clinical Senior Lecturer Respiratory Epidemiology Respiratory Epidemiology, Occupational Medicine and Public Health National Heart and Lung Institute Imperial College London Dr. Quint[/caption] Dr Jennifer K Quint MSc PhD FHEA FRCP Clinical Senior Lecturer Respiratory Epidemiology Respiratory Epidemiology, Occupational Medicine and Public Health National Heart and Lung Institute Imperial College London  MedicalResearch.com: What is the background for this study? What are the main findings? Response: We were commissioned by the Chartered Society of Physiotherapy in the UK to undertake a piece of work to show the value of pulmonary rehabilitation in reducing exacerbations in COPD patients so that they could create a web based tool that would show cost savings if GPs actually referred people for pulmonary rehabilitation. Previous systematic reviews have found that pulmonary rehab can reduce hospital admissions but those groups are often small and not very generalizable so we decided to look at what happens in a primary care COPD population. Our main finding is that people who are eligible for referral are not being referred  - less than 10% eligible were actually referred.
Author Interviews, Columbia, JAMA, Neurology, Pulmonary Disease / 29.11.2017

MedicalResearch.com Interview with: [caption id="attachment_38612" align="alignleft" width="133"]Jinsy Andrews, MD, MS Director of Neuromuscular Clinical Trials Columbia University The Neurological Institute New York, NY 10032  Dr. Andrews[/caption] Jinsy Andrews, MD, MS Director of Neuromuscular Clinical Trials Columbia University The Neurological Institute New York, NY 10032  MedicalResearch.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.
Author Interviews, Heart Disease, JAMA, Pulmonary Disease, Vanderbilt / 27.10.2017

MedicalResearch.com Interview with: [caption id="attachment_37714" align="alignleft" width="112"]Dr. Evan L. Brittain, MD Assistant Professor of Medicine Vanderbilt University School of Medicine Dr. Brittain[/caption] 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.
Author Interviews, Boehringer Ingelheim, Pharmacology, Pulmonary Disease / 02.10.2017

MedicalResearch.com Interview with: [caption id="attachment_37271" align="alignleft" width="125"]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[/caption] 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.
Asthma, Author Interviews, CDC, Occupational Health, Pulmonary Disease / 28.09.2017

MedicalResearch.com Interview with: [caption id="attachment_37228" align="alignleft" width="125"]Katelynn Dodd MPH Respiratory Health Division National Institute for Occupational Safety and Health Centers for Disease Control and Prevention Morgantown WV 26505 Katelynn Dodd[/caption] 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).
Anesthesiology, Author Interviews, JAMA, Pediatrics, Pulmonary Disease / 26.09.2017

MedicalResearch.com Interview with: [caption id="attachment_37063" align="alignleft" width="125"]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[/caption] 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.
Author Interviews, NEJM, Pulmonary Disease / 10.09.2017

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.
Author Interviews, Pharmacology, Pulmonary Disease, University of Michigan / 09.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35150" align="alignleft" width="174"]Kevin R. Flaherty Dr. Flaherty[/caption] 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.
Author Interviews, Biomarkers, Pediatrics, Pulmonary Disease / 07.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35124" align="alignleft" width="133"]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[/caption] 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.
Author Interviews, Pulmonary Disease / 23.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34803" align="alignleft" width="175"]Catherine Bonham MD Section of Pulmonary and Critical Care Medicine University of Chicago Dr. Bonham[/caption] 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.
Author Interviews, Boehringer Ingelheim, Immunotherapy, Pulmonary Disease / 27.04.2017

MedicalResearch.com Interview with: [caption id="attachment_34196" align="alignleft" width="167"]Thomas Leonard, Ph.D. Executive director, Clinical Development and Medical Affairs, Specialty Care Boehringer Ingelheim Pharmaceuticals, Inc. Dr. Thomas Leonard[/caption] 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.
Author Interviews, Pulmonary Disease / 14.04.2017

MedicalResearch.com Interview with: [caption id="attachment_33897" align="alignleft" width="200"]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[/caption] 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.
Author Interviews, BMC, End of Life Care, Pulmonary Disease / 31.03.2017

MedicalResearch.com Interview with: [caption id="attachment_33567" align="alignleft" width="180"]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[/caption] 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.
Annals Internal Medicine, Author Interviews, Pulmonary Disease / 13.03.2017

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 .
Author Interviews, Immunotherapy, Pulmonary Disease / 17.02.2017

MedicalResearch.com Interview with: [caption id="attachment_32136" align="alignleft" width="133"]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[/caption] 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.
Author Interviews, Environmental Risks, Herpes Viruses, Pulmonary Disease / 20.01.2017

MedicalResearch.com Interview with: [caption id="attachment_31387" align="alignleft" width="100"]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[/caption] 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.