Chronic Obstructive Pulmonary Disease (COPD) Post-hospitalization Study
Status:
Completed
Trial end date:
2012-05-08
Target enrollment:
Participant gender:
Summary
This trial is a randomized, double-blind, parallel-group, multicenter study to be conducted
in the United States. The purpose of the study is to evaluate the rate of exacerbations of
chronic obstructive pulmonary disease (COPD) following hospital discharge for an acute
exacerbation of COPD, in patients receiving either fluticasone propionate/salmeterol
combination product 250/50mcg BID or salmeterol 50mcg BID via DISKUS™ over 29 weeks. The
study population will include patients hospitalized for an acute exacerbation of COPD. The
target enrolment is 720 subjects at 80 study centers. The primary endpoint is the rate of
exacerbation requiring hospitalization that occur more than 21 days post-discharge, emergency
room visit or physician's office visit for an exacerbation of COPD requiring treatment with
oral corticosteroids or oral corticosteroids and antibiotics. The secondary endpoint is the
rate of COPD exacerbation requiring treatment with oral corticosteroids, antibiotics, and/or
hospitalization (alone and in combination). Related efficacy endpoints include, time to first
exacerbation of COPD requiring treatment with oral corticosteroids, antibiotics, and/or
hospitalization (alone and in combination), pre-dose AM FEV1, the probability of premature
withdrawal of subject from the study, and supplemental albuterol use, change in biomarkers of
inflammation, including, surfactant protein D (SP-D), clara cell secretory protein 16 (CC-16)
and high sensitivity C-reactive protein (hs-CRP). Health outcome assessments include domain
scores evaluation for fatigue, dyspnea, emotional function and mastery, measured with the
Chronic Respiratory Disease Questionnaire self-administered standardized format (CRQ-SAS);
and symptoms (congestion, cough, phlegm, mucus, chest discomfort, shortness of breath and
sleep disturbance), assessed by the EXAcerbations of Chronic pulmonary disease Tool (EXACT).
Albuterol will be supplied to study subjects for use as-needed throughout the study. Safety
will be assessed by monitoring of adverse events.
Phase:
Phase 4
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Adrenergic Agonists Fluticasone Fluticasone Propionate, Salmeterol Xinafoate Drug Combination Fluticasone-Salmeterol Drug Combination Salmeterol Xinafoate