See Detailed Description
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- GlaxoSmithKline
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.
Detailed Description
Clinical Evaluation of GW815SF for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) "Assessment of the Effect of Addition of Fluticasone Dipropionate to Salmeterol Xinafoate 50µg after Switching under Double-blinded conditions to GW815SF 50/250µg in Chronic Obstructive Pulmonary Disease
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg
Secondary Outcomes
- Change in morning PEF
- Changes in pre-dose FVC, V50, V25
- Use of rescue medication
- Changes in symptom scores