Status:
COMPLETED
A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS® Inhaler 250/50mcg Plus SPIRIVA HANDIHALER® Inhaler Versus SPIRIVA HANDIHALER® Inhaler Plus Placebo DISKUS® Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-99 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhale...
Eligibility Criteria
Inclusion
- COPD diagnosis
- At least 10 pack year smoking history
- Post-albuterol FEV1 greater than or equal to 40% to less than or equal to 80% of predicted normal
- An FEV1/FVC ratio of less than or equal to 0.70
Exclusion
- Current diagnosis of asthma
- Other respiratory disorder other than COPD
- Abnormal and clinical significant ECG
- Chest x-ray clinically significant abnormality not believed to be due to COPD
- Body Mass Index of greater than or equal to 40/kg/m2
- Use of Long Term Oxygen Therapy
- Lung resection surgery
- Women pregnant or lactating at Visit 1
- Previously diagnosed cancer unless in complete remission for 2 years at Visit 1
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT00784550
Start Date
December 1 2008
End Date
December 1 2009
Last Update
November 23 2016
Active Locations (35)
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1
GSK Investigational Site
Riverside, California, United States, 92506
2
GSK Investigational Site
Fort Collins, Colorado, United States, 80528
3
GSK Investigational Site
Clearwater, Florida, United States, 33756
4
GSK Investigational Site
DeLand, Florida, United States, 32720