A Randomized, Double-blind Placebo-controlled Study of Treatments With Salmeterol, Fluticasone Propionate and Their Combination to Evaluate Novel Endpoints in Patients With Chronic Obstructive Pulmonary Disease
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 163
- Locations
- 11
- Primary Endpoint
- Peripheral airway resistance measured by IOS
Study Overview
Brief Summary
This study will last for approximately 14 weeks and will involve 5 visits. The study is being carried out to look at different ways of measuring the effect of drug treatment on COPD. COPD is a respiratory disease which can affect your breathing and daily life. Symptoms of COPD can include breathlessness, cough, and wheeze. COPD varies enormously from patient to patient. The effects of drug treatment are usually measured by conducting lung function tests (breathing tests) using a machine called a spirometer but this does not always provide a complete picture of how well your COPD is responding. In this study we therefore want to look at new and more sensitive ways of measuring COPD. The results of this research will help in the assessment of new drugs for COPD in the future.
Detailed Description
Evaluation of Novel Endpoints in Subjects with Chronic Obstructive Pulmonary Disease (COPD) in a Randomized, Double-Blind, Placebo-Controlled Study of Treatment with Fluticasone Propionate/Salmeterol 500/50mcg combination (FSC 500/50) and its individual components, Fluticasone Propionate 500mcg (FP500) and Salmeterol 50mcg (SAL 50)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of COPD
- •Current or ex-smoker at least 10 pack- years
Exclusion Criteria
- •Diagnosis of asthma
- •Active respiratory disorder other than COPD
- •Evidence of clinically significant uncontrolled non-pulmonary disease
- •Carcinoma not in complete remission for last 5 years
- •Lung volume reduction surgery in previous 12 months
- •Nocturnal positive pressure for sleep apnea
- •Other inclusion and exclusion criteria will be evaluated at the first study visit.
Outcomes
Primary Outcomes
Peripheral airway resistance measured by IOS
Secondary Outcomes
- Airway wall thickness measured by CT scans