Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: fluticasone propionate DISKUS 500mcg

Drug: fluticasone propionate/salmeterol 250/50 DISKUS combination product

Study type

Interventional

Funder types

Industry

Identifiers

NCT00549146

SCO40055

Details and patient eligibility

About

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.

Full description

Multi-centre, double-blind, randomised and stratified parallel group study to compare the efficacy and safety of fluticasone propionate 500 mcg bd versus salmeterol/fluticasone combination 50/250 mcg bd both via Diskus inhaler during 1 year in Chronic Obstructive Pulmonary Disease(COPD) patients with a partially reversible obstruction.

Enrollment

290 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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.