Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Salmeterol/fluticasone propionate 50/500mcg Diskus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00268177

SCO30005

Details and patient eligibility

About

This study was designed to look at effects of salmeterol/fluticasone propionate compared to placebo on airway inflammation in patients with chronic obstructive airways disease

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Established clinical history of chronic obstructive airways disease.
• Must be current or ex-smokers with a smoking history of at least 10 pack-years (e.g. 20 cigarettes/day for 10 years or 10 cigarettes/day for 20 years).
• Must have reduced lung function, defined as a Forced Expiratory Volume in 1 second (FEV1) of between 40-80% of predicted normal values.

Exclusion criteria

• Diagnosis of any other serious disease and must have a chest X-ray to eliminate a diagnosis other than COPD.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind