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Clinical Trials/NCT00269126
NCT00269126
Completed
Phase 3

See Detailed Description

GlaxoSmithKline1 site150 target enrollmentFebruary 2005

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

Registry
clinicaltrials.gov
Start Date
February 2005
End Date
August 2005
Last Updated
13 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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

Study Sites (1)

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