A Randomized, Double-Blind, Parallel-Group, 12-Week Study to Evaluate the Anti-Inflammatory Effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg BID Compared With Salmeterol DISKUS 50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Overview
- Phase
- Phase 4
- Intervention
- Salmeterol
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- GlaxoSmithKline
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Percent of sputum neutrophils
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic. Subjects who elect to undergo bronchoalveolar lavage (BAL) procedures will have 8 study visits. Subjects will give sputum, blood, and in some cases BAL samples. Subjects will have breathing tests and will complete diary cards during the study. All study medicines and examinations will be given at no cost to the study subjects. Both medicines used in this study have been approved by the US FDA.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of COPD.
- •Pre-bronchodilator FEV1 less than or equal to 70.0% and greater than or equal to 0.70L
- •Ex-Smokers with at least a 10 pack-year history.
Exclusion Criteria
- •Current of secondary diagnosis of asthma or current diagnosis of atopy.
- •Other respiratory disorders other than COPD.
- •Other inflammatory diseases.
- •Abnormal and clinically significant chest x-ray or ECG.
- •Lung resection surgery within past 1 year.
- •History of cancer not in remission within past 2 years.
- •Serious, uncontrolled disease.
- •Pregnancy or planning to become pregnant during the study.
Arms & Interventions
Arm 1
Intervention: Salmeterol
Arm 1
Intervention: Fluticasone Propionate/Salmeterol Combination Product
Outcomes
Primary Outcomes
Percent of sputum neutrophils
Secondary Outcomes
- Inflammation endpoints: Cell counts in sputum, cell counts and protein markers in BAL, protein markers in blood Clinical endpoints: FEV1 Airway conductance and airway resistance Functional residual capacity Shortness of breath symptoms