Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Study MEA117106: Mepolizumab vs. Placebo as add-on Treatment for Frequently Exacerbating COPD Patients
This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial
evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC)
injection.
In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in
severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in
COPD patients would translate into a reduction of COPD exacerbations. The study will
determine the reduction in exacerbations in subjects who are above and below the baseline
blood eosinophil count of at least 150 cells/microlitres. The study will evaluate the
efficacy and safety of mepolizumab on the frequency of moderate and severe exacerbations in
COPD subjects at high risk of exacerbations, despite the use of optimized standard of care
background therapy.
Overall in this study, a total of 800 subjects will be randomised in 1:1 ratio to receive
placebo or mepolizumab (100 milligram (mg)) administered SC. The total duration of this study
will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week
treatment period and 8-week follow-up period.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05043428 -
The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD
|
N/A | |
| Completed |
NCT00528996 -
An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.
|
Phase 2 | |
| Completed |
NCT03740373 -
A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate
|
Phase 1 | |
| Completed |
NCT05402020 -
Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
|
||
| Completed |
NCT05393245 -
Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
|
||
| Completed |
NCT04011735 -
Re-usable Respimat® Soft MistTM Inhaler Study
|
||
| Enrolling by invitation |
NCT03075709 -
The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan
|
||
| Completed |
NCT03764163 -
Image and Model Based Analysis of Lung Disease
|
Early Phase 1 | |
| Completed |
NCT00515268 -
Endotoxin Challenge Study For Healthy Men and Women
|
Phase 1 | |
| Completed |
NCT04085302 -
TARA Working Prototype Engagement Evaluation: Feasibility Study
|
N/A | |
| Completed |
NCT03691324 -
Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study
|
N/A | |
| Completed |
NCT02236611 -
A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
| Completed |
NCT00153075 -
Flow Rate Effect Respimat Inhaler Versus a Metered Dose Inhaler Using Berodual in Patients With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
| Completed |
NCT01009463 -
A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
| Completed |
NCT01017952 -
A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
| Completed |
NCT04882124 -
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD
|
Phase 2 | |
| Completed |
NCT02853123 -
Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients
|
Phase 4 | |
| Completed |
NCT02619357 -
Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma
|
Phase 1 | |
| Recruiting |
NCT05858463 -
High Intensity Interval Training and Muscle Adaptations During PR
|
N/A | |
| Not yet recruiting |
NCT05032898 -
Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II
|