Dose Finding Study of Nemiralisib (GSK2269557) in Subjects With an Acute Moderate or Severe Exacerbation...
Pulmonary DiseaseChronic ObstructiveNemiralisib is being developed as an anti-inflammatory drug for the treatment of inflammatory airways disease. This study is designed to assess the dose response, efficacy, safety, and pharmacokinetics of nemiralisib across a range of doses [up to 750 micrograms (µg)] compared with placebo. The study consists of a Screening Period, a 12-Week Treatment Period and a 12-Week Post-Treatment Follow-Up Period. Approximately 1,250 subjects with an acute moderate or severe exacerbation of COPD requiring standard of care (SoC) therapy will be randomized in this double-blind study. Subjects will be randomized to receive different doses of nemiralisib or placebo via ELLIPTA® inhaler. The total duration of study participation is approximately 6 months (170 days). ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.
Dose Escalating Study of CCI15106 Inhalation Capsules in Healthy Subjects and Moderate Chronic Obstructive...
Pulmonary DiseaseChronic ObstructiveThis study will be the first administration of CCI15106 capsules for inhalation to humans. The primary objective of the study is to investigate the safety and tolerability of single and repeat escalating doses of CCI15106 in healthy subjects and patients with moderate chronic obstructive pulmonary disease (COPD). The intention of this study is to provide sufficient confidence in the safety of the molecule delivered by inhalation to inform progression to further repeat dose and proof of concept studies. This will be a three-part study. Part 1 will investigate single ascending doses and Part 2 repeat ascending doses in healthy subjects. In Part 3, a single dose will be administered to patients with moderate COPD. There will be screening period of up to 30 days. The treatment period will be 3 days for Parts 1 and 3 and 16 days for Part 2. Follow-up will be performed within 30 days after the last dose.
A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants...
Pulmonary HypertensionChronic Obstructive Pulmonary DiseaseThe primary objective of this study is to demonstrate the efficacy of inhaled treprostinil compared to placebo in improving exercise ability as measured by change from baseline in 6-Minute Walk Distance (6MWD) following 12 weeks of active treatment in participants with PH-COPD.
Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency
Chronic Obstructive Pulmonary DiseaseAlpha1-antitrypsin DeficiencyThe purpose of this study is to conduct a pilot study to evaluate the safety and efficacy of weekly administration of Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy in subjects with A1PI deficiency and emphysema/ chronic obstructive pulmonary disease (COPD).
Respiratory EMG for NIV Titration in Stable COPD Patients
Chronic Obstructive Pulmonary Disease (COPD)The aim of the present study is to investigate whether additional titration on surface electromyography (EMG) of the diaphragm and intercostal muscles improves the outcome of chronic non-invasive ventilation in patients with COPD and stable chronic hypercapnic respiratory failure in terms of better gas exchange after six weeks, lung function, patient comfort and compliance, and less patient ventilator asynchrony. Therefore, the investigators set up a randomized, two-armed crossover trial comparing regular titration with additional respiratory EMG titration of NIV.
The Effect of NIV on QoL and Exercise Capacity in a COPD Exercise Rehabilitation Program
Chronic Obstructive Pulmonary DiseaseThis trial hopes to demonstrate the effect of 4 weeks of outpatient exercise rehabilitation on COPD patients. In particular the effect on: the amount of daily physical activity Quality of life The 6-minute walk distance Time to exacerbation and compare it to the effect of 4 weeks of outpatients rehabilitation with Noninvasive Ventilation as an adjunct therapy.
Azithromycin for Acute Exacerbations Requiring Hospitalization
Chronic Obstructive Pulmonary DiseaseThis project (funded by the IWT-TBM program) will organize a randomized placebo-controlled multicenter intervention trial in 500 COPD patients to study the effectiveness and safety of azithromycin therapy in the acute setting of COPD exacerbations requiring hospital admission. Although long-term use of azithromycin is proven effective to prevent exacerbations, inherent risks outweigh the benefits. By reducing the dose and duration of the azithromycin treatment and by restricting the treatment to acute periods with highest risk for treatment failure, benefits may counterbalance potential side effects, which may result in a new treatment strategy for these acute events. The present study is designed by the services of respiratory medicine of the Leuven and Ghent University hospitals but will run in total in 17 different large hospitals in Belgium, of which 12 are located in Flanders.
Pulmonary Rehab in Chronic Obstructive Pulmonary Disease (COPD): Response to Tyvaso
Chronic Obstructive Pulmonary Disease (COPD)The investigators' hypothesis is that pretreating patients with COPD with inhaled treprostinil prior to pulmonary rehabilitation sessions will result in improved exercise tolerance during sessions. This in turn will lead to an increased response to pulmonary rehabilitation, resulting in improved exercise tolerance and quality of life.
A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 in Chronic...
Chronic Obstructive Pulmonary DiseaseCOPDThis study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active comparator.
Non-invasive Ventilation in Severe Chronic Obstructive Pulmonary Disease(COPD)
Chronic Obstructive Pulmonary DiseaseHypercapniaNon-invasive ventilation is frequently applied in patients with acute exacerbation of COPD, but no evidence exists about the effect of long term application/home application. This study tests the hypothesis, that a daily, 6 hour application of non-invasive ventilation over one year improves survival, exercise capacity, and quality of life in patients with advanced stages of COPD.