Chronic Obstructive Pulmonary Disease Endpoints Study

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

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.

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)

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.

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Kreindler JL, Watkins ML, Lettis S, Tal-Singer R, Locantore N. Effect of inhaled corticosteroids on blood eosinophil count in steroid-naive patients with COPD. BMJ Open Respir Res. 2016 Sep 8;3(1):e000151. doi: 10.1136/bmjresp-2016-000151. eCollection 2016.

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.