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).

Completed · Phase 4

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH \& Co. KG. ADVAIR DISKUS® are registered trademarks of the GSK group of companies.

Key facts

Study ID

NCT00784550

Run by

GlaxoSmithKline

People needed

342

Starts

2008-12-01

Expected to finish

2009-12-01

Last updated by the study team

2016-11-23

Who can join

Age: 40 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Riverside, California, United States
• GSK Investigational Site — Fort Collins, Colorado, United States
• GSK Investigational Site — Clearwater, Florida, United States
• GSK Investigational Site — DeLand, Florida, United States
• GSK Investigational Site — Naranja, Florida, United States
• GSK Investigational Site — Coeur d'Alene, Idaho, United States
• GSK Investigational Site — Gillespie, Illinois, United States
• GSK Investigational Site — Elkhart, Indiana, United States
• GSK Investigational Site — Olathe, Kansas, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Shreveport, Louisiana, United States
• GSK Investigational Site — Sunset, Louisiana, United States
• GSK Investigational Site — Saint Charles, Missouri, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — Albany, New York, United States
• GSK Investigational Site — Elizabeth City, North Carolina, United States
• GSK Investigational Site — Mooresville, North Carolina, United States
• GSK Investigational Site — Statesville, North Carolina, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Erie, Pennsylvania, United States
• GSK Investigational Site — Cumberland, Rhode Island, United States
• GSK Investigational Site — Charleston, South Carolina, United States
• GSK Investigational Site — Gaffney, South Carolina, United States
• GSK Investigational Site — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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