Asthma: Biologic Benralizumab (FASENRA) Reduced Need For Rescue Medication

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.  Continue reading

Electronic Decision Support Facilitates Home Discharge of Some PE Patients From ER

Dr-David R Vinson

Dr. Vinson

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.  Continue reading

Cystic Fibrosis Patients May Need Higher Doses of Antibiotics To Clear Lung Infections

MedicalResearch.com Interview with:

Andrea Hahn, M.D., MS Infectious disease specialist and lead study author Children's National Health System

Dr. Hahn

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. Continue reading

Genetic Variant is Risk Factor for Two Different Types of Interstitial Lung Disease

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

Dr. Lee

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.

Continue reading

Nose-Picking Can Spread Pneumonia

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.

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Asthma: Add-on Maintenance Treatment with FASENRA (benralizumab) Can Reduce Exacerbations

MedicalResearch.com Interview with:

Tosh Butt, MBA VP Respiratory AstraZeneca

Tosh Butt

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.

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Inhaled Steroids Associated With Increased Risk of Atypical Mycobacterial Infections

MedicalResearch.com Interview with:

Stephen J Ruoss MD Professor, Stanford University, Medicine, Division of Pulmonary and Cfritical Care Medicine Stanford, California

Dr. Ruoss

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. Continue reading

Effects of Childhood Exposure to Secondhand Smoke Can Drift Into Adulthood

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.

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Some Pulmonary Embolism Patients Can Be Treated at Home

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

Dr. Bledsoe

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.  Continue reading

Daily Chest X-Rays Still Overused in Mechanically Ventilated Patients

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

Dr. Gershengorn

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.

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COPD: Vaporized Cannabis Did Not Reduce Breathlessness or Improve Exercise Capacity

MedicalResearch.com Interview with:

“Cannabis sativa” by Manuel is licensed under CC BY 2.0

cannabis

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. Continue reading

Specific Microbial Signatures Differentiate Chronic Coughs in Children

MedicalResearch.com Interview with:

Dr. Mikhail Kazachkov MD Director of Pediatric Pulmonology Hassenfeld Children’s Hospital NYU Langone Medical Center

Dr. Kazachkov

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.

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Cystic Fibrosis: Antioxidant-Enriched MVI May Decrease Respiratory Illnesses

MedicalResearch.com Interview with:

Scott D Sagel MD PhD Professor of Pediatrics University of Colorado School of Medicine Aurora, Colorado

Dr. Sagel

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.

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Two Studies Evaluate Monoclonal Antibody Tralokinumab For Asthma

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

Dr. Panettieri

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).

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Nintedanib (OFEV®) May Offer Survival Advantage for IPF Patients

MedicalResearch.com Interview with:

Christopher J. Ryerson, M.D. Assistant Professor Centre for Heart Lung Innovation University of British Columbia Vancouver, Canada

Dr. Ryerson

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.  Continue reading

Does Nail Polish Really Affect Pulse Oxygen Reading?

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.

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Antifibrotic Drug Stabilized Lung Function For Patients with Idiopathic Pulmonary Fibrosis

MedicalResearch.com Interview with:

Pierre Laurin, CEO Prometic

Pierre Laurin

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.

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SUNSET Trial Supports Bronchodilators as Foundation of COPD Therapy

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

Dr. Chapman

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.  Continue reading

Early Study Demonstrates Airways Can Be Transplanted from Aortic Templates

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.  Continue reading

Solar Powered Oxygen Could Fill Critical Gap in Underserved Areas

MedicalResearch.com Interview with:

Michael Hawkes MD PhD Adjunct Professor Assistant Professor  Pediatrics, Faculty of Medicine School of Public Health University of Alberta

Dr. Hawkes

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.

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X-Linked Genetic Signatures Linked To Respiratory Disorders in Males

MedicalResearch.com Interview with:

Gustavo Nino, M.D. Children’s National Health System pulmonologist Study senior author

Dr. Nino Barrera

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.

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FDA Grants Fast Track Designation to Nintedanib for Scleroderma with Lung Disease

MedicalResearch.com Interview with:

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

Dr. Thomas Leonard

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.

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Quadrupling Inhaled Steroids May Abort Some Asthma Attacks

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%

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Global Initiative Highlights Inspirational Stories of People Living With Scleroderma

MedicalResearch.com Interview with:

Donald Zoz, MD Senior Associate Director Clinical Development & Medical Affairs IPF/ILD Boehringer Ingelheim Pharmaceuticals, Inc.

Dr. Zoz

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.

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.  Continue reading

Study Finds Pulmonary Embolus Rarely the Cause of Syncope

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.

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