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.
Epstein-Barr Virus Suppression in Chronic Obstructive Pulmonary Disease (EViSCO): a Phase 2 Randomised...
COPDEBVCOPD is a major public health problem and will shortly become the third most common cause of global mortality. There are currently no treatments that can meaningfully alter the progression of COPD or the time to death. Consequently novel therapeutic strategies for COPD are urgently required. This will be a randomised, double-blind, placebo-controlled, trial of Epstein-Barr virus suppression in COPD. Participants will be randomised to receive valaciclovir 1 gram three times daily for 8 weeks or matching placebo. The study will measure EBV suppression using quantitative PCR. Secondary outcomes will include Lung function quality of life and drug tolerability. The exploratory analysis will evaluate biomarkers of airway inflammation within the sputum and blood.
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.
Bubble PEP Training Among Patient With Chronic Obstructive Pulmonary Disease in Pulmonary Function...
Chronic Obstructive Pulmonary Disease With ExacerbationChronic Obstructive Pulmonary Disease Exacerbation1 moreThe morbidity rate of Chronic Obstructive Pulmonary Disease (COPD) is increasing year by year. It is predicted to be the third leading cause of death worldwide in 2030. People with COPD have a high risk of needing a ventilator due to the decline of lung function, the increase of secretions, the dysfunction of airway clearance, and the obstruction and loss of alveolar elasticity.
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.
Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory...
Pulmonary DiseaseChronic ObstructiveIn this study the efficacy of Roflumilast in addition to LAMA/LABA therapy will be assessed using Functional Respiratory Imaging. In total 40 Chronic obstructive pulmonary disease (COPD) patients, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages C and D, who are stable on LABA/LAMA therapy and who are prone to dynamics hyperinflation will be included in this study. To indicate the susceptibility to dynamics hyperinflation patients should have a baseline Borg Fatigue score after the 6-minute walk test (6MWT) above 4. The patients will be randomized in such a way that 1 out of 2 patients will receive placebo and 1 the active component. Image parameters will be assessed and the correlation with lung function and health related quality of life will be checked before and after treatment.
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).
Comparison of Safety and Efficacy of COMBIVENT HFA to COMBIVENT (CFC) in Patients With Chronic Obstructive...
Pulmonary DiseaseChronic ObstructiveTo compare the long-term (one-year) bronchodilator efficacy and safety of COMBIVENT hydrofluoroalkane (HFA) Inhalation Aerosol to COMBIVENT chlorofluorocarbon (CFC) Inhalation Aerosol and Placebo formulations of each in patients with COPD. In addition, steady state pharmacokinetics over one dosing interval following four weeks of therapy will be characterized.
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.