Overview

Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease

Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
0
Participant gender:
All
Summary
Relatively little information is available about the effects of salmeterol/fluticasone combination and fluticasone alone in COPD patients with a partial reversible pulmonary obstruction. The purpose of this study is to compare the effects of salmeterol/fluticasone combination with fluticasone alone delivered via Diskus/ACCUHALER inhaler in subjects with COPD on lung function over a 1 year period.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Fluticasone-Salmeterol Drug Combination
Salmeterol Xinafoate
Xhance
Criteria
Inclusion criteria:

- Established history of chronic obstructive pulmonary disease (COPD).

- Lung function parameters: FEV1/FVC ratio < 70%, FEV1 between 80% and 30% predicted, a
reversibility of airway obstruction of 12% of the initial value with a minimum of 200
mL.

- Signed and dated informed consent.

Exclusion criteria:

- History of asthma or allergy.

- Unstable COPD in the 3 months before the study.

- Interference of non-pulmonary medication or diseases with COPD outcome parameters.