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NCT00784550 · ClinicalTrials.gov registry record · Phase 4
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).
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 342
- Enrollment target
NCT00784550: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT00784550 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 342 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00784550, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 342 participants
- Enrollment target
Study 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® 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.
Primary Outcome
Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.
Interventions
- DRUG Fluticasone Propionate/Salmeterol
- DRUG Tiotropium Bromide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 342 participants |
| Start Date | 2008-12 |
| Est. Completion | 2009-12 |
| Phase | Phase 4 |
What the finished NCT00784550 record still lists
NCT00784550 is an interventional study that assigns participants to a tested intervention. The registered 342 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 2 interventions - of which Fluticasone Propionate/Salmeterol is the first listed.
NCT00784550 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00784550 about?
NCT00784550 is a clinical study titled "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).". 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 CO...
What is the current status of trial NCT00784550?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 342 participants. The study started on 2008-12. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00784550?
The interventions under investigation include: Fluticasone Propionate/Salmeterol (DRUG), Tiotropium Bromide (DRUG).
Who is sponsoring clinical trial NCT00784550?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00784550's enrollment target sits among peer trials
342 246th of 2000 higher than 1,755 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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