Back to resultsClinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
fluticasone propionate/salmeterol combination DISKUS
salmeterol xinafoate
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD, Chronic Bronchitis, Emphysema
Eligibility Criteria
Inclusion criteria: Diagnosis of COPD. Exclusion criteria: Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD. Other inclusion and exclusion criteria will be evaluated at the first study visit.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg
Secondary Outcome Measures
Change in morning PEF
Changes in pre-dose FVC, V50, V25
Use of rescue medication
Changes in symptom scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00269126
Brief Title
Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)
Official Title
See Detailed Description
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
COPD, Chronic Bronchitis, Emphysema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
fluticasone propionate/salmeterol combination DISKUS
Intervention Type
Drug
Intervention Name(s)
salmeterol xinafoate
Other Intervention Name(s)
fluticasone propionate/salmeterol combination DISKUS
Primary Outcome Measure Information:
Title
Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg
Secondary Outcome Measure Information:
Title
Change in morning PEF
Title
Changes in pre-dose FVC, V50, V25
Title
Use of rescue medication
Title
Changes in symptom scores
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Diagnosis of COPD.
Exclusion criteria:
Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD.
Other inclusion and exclusion criteria will be evaluated at the first study visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Kyoto
ZIP/Postal Code
602-8026
Country
Japan
Facility Name
GSK Investigational Site
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)
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