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copd randomized controlled trial

Enya Daynes, Neil J Greening, Theresa C Harvey-Dunstan, Sally J Singh
BACKGROUND: COPD is characterized by expiratory flow limitation, which results in symptomatic dyspnea and reduced exercise capacity. Changes in breathing mechanics mean the respiratory muscles are unable to respond to the ventilatory demands, increasing the sensation of dyspnea. A high-frequency oscillating device has been developed to improve dyspnea in patients with COPD. We conducted a feasibility trial to gain insight into the potential for recruitment, retention, and study design for a future randomized controlled trial...
March 13, 2018: Respiratory Care
Edward M Kerwin, Selwyn Spangenthal, Christine Kollar, Earl St Rose, Colin Reisner
BACKGROUND: Long-acting muscarinic antagonist (LAMA) and long-acting β2 -agonist (LABA) bronchodilators are key to the pharmacologic treatment of chronic obstructive pulmonary disease (COPD). This Phase IIb study investigated the safety and efficacy of four doses of the LAMA glycopyrronium (GP) delivered using co-suspension delivery technology via metered dose inhaler (MDI). The study was part of a wider clinical trial program performed to determine the optimal dose of GP MDI, the LABA formoterol fumarate dihydrate (FF) MDI, and glycopyrronium/formoterol fumarate dihydrate (GFF) MDI fixed-dose combination to be taken forward into Phase III studies...
March 5, 2018: Respiratory Research
Jian Luo, Ling Yang, Jing Yang, Dan Yang, Bi-Cui Liu, Dan Liu, Bin-Miao Liang, Chun-Tao Liu
Phosphodiesterase 4 (PDE4) inhibitors are a novel medication approved for airway inflammatory diseases including chronic obstructive pulmonary disease. Their role and application in asthma are controversial and not defined. A comprehensive search was performed in major databases (1946-2016) using the keywords: 'phosphodiesterase 4 inhibitor' or 'roflumilast' and 'asthma'. Placebo-controlled trials reporting lung function, airway hyperresponsiveness by direct challenge, asthma control and exacerbations, and adverse events were included...
March 4, 2018: Respirology: Official Journal of the Asian Pacific Society of Respirology
Ofra Kalter-Leibovici, Michal Benderly, Laurence S Freedman, Galit Kaufman, Tchiya Molcho Falkenberg Luft, Havi Murad, Liraz Olmer, Meri Gluch, David Segev, Avi Gilad, Said Elkrinawi, Tali Cukierman-Yaffe, Baruch Chen, Orit Jacobson, Calanit Key, Mordechai Shani, Gershon Fink
RATIONALE: The efficacy of disease management programs in the treatment of patients with chronic obstructive pulmonary disease (COPD) remains uncertain. OBJECTIVE: To study the effect of disease management (DM) added to recommended care (RC) in ambulatory COPD patients. MEASUREMENTS AND MAIN RESULTS: In this trial, 1,202 COPD patients (age >40 years), with moderate to very severe airflow limitation were randomly assigned either to DM plus RC (study intervention) or to RC alone (control intervention)...
March 1, 2018: American Journal of Respiratory and Critical Care Medicine
Jens M Hohlfeld, Jens Vogel-Claussen, Heike Biller, Dominik Berliner, Korbinian Berschneider, Hanns-Christian Tillmann, Simone Hiltl, Johann Bauersachs, Tobias Welte
BACKGROUND: Pulmonary hyperinflation in chronic obstructive pulmonary disease (COPD) is associated with reduced biventricular end-diastolic volumes and increased morbidity and mortality. The combination of a long-acting β agonist (LABA) and a muscarinic antagonist (LAMA) is more effective in reducing hyperinflation than LABA-inhaled corticosteroid combination therapy but whether dual bronchodilation improves cardiac function is unknown. METHODS: We did a double-blind, randomised, two-period crossover, placebo-controlled, single-centre study (CLAIM) at the Fraunhofer Institute of Toxicology and Experimental Medicine (Hannover, Germany), a specialty clinic...
February 21, 2018: Lancet Respiratory Medicine
Sabrina Storgaard Sørensen, Morten Berg Jensen, Kjeld Møller Pedersen, Lars Ehlers
OBJECTIVES: To examine the heterogeneity in cost-effectiveness analyses of patient-tailored complex interventions. METHODS: Latent class analysis (LCA) was performed on data from a randomized controlled trial evaluating a patient-tailored case management strategy for patients suffering from chronic obstructive pulmonary disease (COPD). LCA was conducted on detailed process variables representing service variation in the intervention group. Features of the identified latent classes were compared for consistency with baseline demographic, clinical, and economic characteristics for each class...
February 2018: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Shin-Hwar Wu, Lih-Jen Shyu, Chin-Hsing Li, Chao-Hung Yu, Huang-Chi Chen, Chew-Teng Kor, Chu-Hsien Wang, Kai-Huang Lin
INTRODUCTION: The optimal dose of inhaled metered-dose bronchodilators for intubated patients with chronic obstructive pulmonary disease (COPD) is unknown. In this study, we proposed a bronchodilator dosing schedule based on an individual's airway resistance (Raw ) and tested its efficacy in reducing Raw . METHODS: A total of 51 newly admitted patients with invasively ventilated COPD were randomly assigned to receive personalized or fixed bronchodilator dosing. Personal target Raw was defined by measuring each individual's Raw after maximal pharmacologic bronchodilatation...
February 20, 2018: Pulmonary Pharmacology & Therapeutics
Anthony W Huckle, Lucy C Fairclough, Ian Todd
Antibiotics have previously demonstrated anti-inflammatory properties, and they have been linked to therapeutic benefit in several pulmonary conditions that feature inflammation. Previous research suggests that these anti-inflammatory properties may be beneficial in the treatment of COPD. This review assesses the potential benefit of prophylactic, long-term, and low-dose antibiotic therapy in COPD, and whether any effects seen are anti-inflammatory in nature. Randomized, controlled trials comparing antibiotic therapy with placebo in subjects with stable COPD were evaluated...
February 20, 2018: Respiratory Care
Gerard M Turino
This article assesses developments in cardiorespiratory medicine since the Nobel Prize in Physiology or Medicine was awarded in 1956 for advancements in the study of cardiorespiratory disease. In chronic obstructive pulmonary disease, advances were accelerated by the discovery of a genetically determined cause for pulmonary emphysema in the genetic abnormality alpha-1 antitrypsin deficiency. This causes a deficiency of the inhibitor of neutrophil elastase, which results in increased degradation of lung elastin and the development of pulmonary emphysema...
February 2018: Annals of the American Thoracic Society
L Liu, J-L Wang, X-Y Xu, M Feng, Y Hou, L Chen
OBJECTIVE: Leukotriene receptor antagonists (LTRA), the anti-inflammatory agents, have been reported new therapeutic value in chronic obstructive pulmonary disease (COPD). However, the effects of LTRA on lung function decline in COPD were determined with inconsistent results and a meta-analysis is needed. MATERIALS AND METHODS: Published cohort or randomized controlled studies were retrieved from PubMed and Embase databases. RESULTS: Pooled standardized mean difference (SMD) with 95% confidence interval (CI) was calculated in a random effects model...
February 2018: European Review for Medical and Pharmacological Sciences
Daniele Oliveira Dos Santos, Hugo Celso Dutra de Souza, José Antônio Baddini-Martinez, Ercy Mara Cipulo Ramos, Ada Clarice Gastaldi
BACKGROUND: Bronchiectasis is characterized by pathological and irreversible bronchial dilatation caused by the inefficient mucus and microorganism clearance and progression of inflammatory processes. The most frequent characteristic is the increase in bronchial mucus production resulting in slower transport and damage to the mucociliary transport. AIMS: To evaluate the effects of exercise on mucus transport, inflammation, and resistance of the respiratory and autonomic nervous systems and subsequent effects on quality of life in patients with bronchiectasis who are enrolled in a pulmonary rehabilitation program...
February 2018: Medicine (Baltimore)
Elizabeth Broadbent, Jeff Garrett, Nicola Jepsen, Vickie Li Ogilvie, Ho Seok Ahn, Hayley Robinson, Kathryn Peri, Ngaire Kerse, Paul Rouse, Avinesh Pillai, Bruce MacDonald
BACKGROUND: Socially assistive robots are being developed for patients to help manage chronic health conditions such as chronic obstructive pulmonary disease (COPD). Adherence to medication and availability of rehabilitation are suboptimal in this patient group, which increases the risk of hospitalization. OBJECTIVE: This pilot study aimed to investigate the effectiveness of a robot delivering telehealth care to increase adherence to medication and home rehabilitation, improve quality of life, and reduce hospital readmission compared with a standard care control group...
February 13, 2018: Journal of Medical Internet Research
François Maltais, Denis O'Donnell, Juan Bautista Gáldiz Iturri, Anne-Marie Kirsten, Dave Singh, Alan Hamilton, Kay Tetzlaff, Yihua Zhao, Richard Casaburi
BACKGROUND: The TORRACTO® study evaluated the effects of tiotropium/olodaterol versus placebo on endurance time during constant work-rate cycling and constant speed shuttle walking in patients with chronic obstructive pulmonary disease (COPD) after 12 weeks of treatment. METHODS: The effects of once-daily tiotropium/olodaterol (2.5/5 and 5/5 μg) on endurance time during constant work-rate cycle ergometry (CWRCE) after 6 and 12 weeks of treatment were compared with placebo in patients with COPD in a randomized, double-blind, placebo-controlled, parallel-group clinical trial...
January 2018: Therapeutic Advances in Respiratory Disease
Alberto Papi, Jørgen Vestbo, Leonardo Fabbri, Massimo Corradi, Hélène Prunier, Géraldine Cohuet, Alessandro Guasconi, Isabella Montagna, Stefano Vezzoli, Stefano Petruzzelli, Mario Scuri, Nicolas Roche, Dave Singh
BACKGROUND: Evidence is scarce on the relative risk-benefit of inhaled triple therapy, consisting of inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting β2 -agonist, versus dual bronchodilation for chronic obstructive pulmonary disease (COPD). We aimed to compare a single-inhaler triple combination of beclometasone dipropionate, formoterol fumarate, and glycopyrronium (BDP/FF/G) versus a single-inhaler dual bronchodilator combination of indacaterol plus glycopyrronium (IND/GLY) in terms of the rate of moderate-to-severe COPD exacerbations over 52 weeks of treatment...
February 8, 2018: Lancet
Andrew R Levy, Bashir Matata, Sam Pilsworth, Adrian Mcgonigle, Lyndsey Wigelsworth, Linda Jones, Nicola Pott, Max Bettany, Adrian W Midgley
Background: Chronic obstructive pulmonary disease (COPD) is a degenerative condition that can impair health-related quality of life (HRQoL). A number of self-management interventions, employing a variety of behavioural change techniques (BCTs), have been adopted to improve HRQoL for COPD patients. However, a lack of attention has been given to group management interventions with an emphasis on incorporating BCTs into rehabilitators' practice. This study aims to pilot and feasibly explore a social identity group management intervention, delivered by COPD rehabilitation staff to patients attending exercise pulmonary rehabilitation...
2018: Pilot and Feasibility Studies
Carol Kelly, Seamus Grundy, Dave Lynes, David Jw Evans, Sharada Gudur, Stephen J Milan, Sally Spencer
BACKGROUND: Bronchiectasis is a long term respiratory condition with an increasing rate of diagnosis. It is associated with persistent symptoms, repeated infective exacerbations, and reduced quality of life, imposing a burden on individuals and healthcare systems. The main aims of therapeutic management are to reduce exacerbations and improve quality of life. Self-management interventions are potentially important for empowering people with bronchiectasis to manage their condition more effectively and to seek care in a timely manner...
February 7, 2018: Cochrane Database of Systematic Reviews
David M Levine, Kei Ouchi, Bonnie Blanchfield, Keren Diamond, Adam Licurse, Charles T Pu, Jeffrey L Schnipper
BACKGROUND: Hospitals are standard of care for acute illness, but hospitals can be unsafe, uncomfortable, and expensive. Providing substitutive hospital-level care in a patient's home potentially reduces cost while maintaining or improving quality, safety, and patient experience, although evidence from randomized controlled trials in the US is lacking. OBJECTIVE: Determine if home hospital care reduces cost while maintaining quality, safety, and patient experience...
February 6, 2018: Journal of General Internal Medicine
Lu-Fei Shen, Xiao-Dong Lv, Wen-Yu Chen, Qi Yang, Zhi-Xian Fang, Wei-Fen Lu
BACKGROUND: Randomized controlled trials (RCTs) of roflumilast effect on chronic obstructive pulmonary disease (COPD) have been reported in the last decade. The current meta-analysis was designed to systematically review and perform meta-analysis of the RCTs of roflumilast treatment in COPD. METHODS: Electronic databases including PubMed, EMBASE, Web of Science, and Cochrane clinical trials database were searched to identify RCTs of roflumilast treatment on COPD...
February 3, 2018: Irish Journal of Medical Science
Alex R Jenkins, Holly Gowler, Ffion Curtis, Neil S Holden, Christopher Bridle, Arwel W Jones
Introduction: The clinical benefit of continued supervised maintenance exercise programs following pulmonary rehabilitation in COPD remains unclear. This systematic review aimed to synthesize the available evidence on the efficacy of supervised maintenance exercise programs compared to usual care following pulmonary rehabilitation completion on health care use and mortality. Methods: Electronic databases (MEDLINE, Embase, CINAHL, Cochrane Central Register of Controlled Trials, Web of Science, and PEDro) and trial registers (ClinicalTrials...
2018: International Journal of Chronic Obstructive Pulmonary Disease
Sally Singh, François Maltais, Lee Tombs, William A Fahy, Mitra Vahdati-Bolouri, Nicholas Locantore, John H Riley
Background: Lung hyperinflation and exercise intolerance are hallmarks of chronic obstructive pulmonary disease (COPD). However, their relationship remains uncertain. A combined analysis of two placebo-controlled, randomized studies examined the effects of the long-acting muscarinic antagonist umeclidinium (UMEC) and long-acting β2-agonist vilanterol (VI) separately and in combination on static hyperinflation, exercise endurance time (EET), and their relationship in patients with COPD...
2018: International Journal of Chronic Obstructive Pulmonary Disease
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