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NCT00857766 · ClinicalTrials.gov registry record · Phase 4
A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 249
- Enrollment target
- 20
- Study locations
NCT00857766: Completed Phase 4 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
NCT00857766 is a Phase 4 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 249 participants, below the 1,041-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00857766, a Phase 4 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 249 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate in patients with Chronic Obstructive Pulmonary Disease (COPD) if Advair DISKUS™ 250/50mcg BID modifies arterial stiffness which is a measure associated with risk of heart disease.
Primary Outcome
The 12-week Endpoint is defined as the last scheduled measurement of PWV during the 12-week double-blind treatment period (from Visits 3-5; Weeks 4, 8, and 12, respectively), and Baseline is defined as the PWV measure from Visit 2 (Randomization). Change from Baseline was calculated as the Endpoint value minus the Baseline Value. PWV is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the PW along an artery
Conditions Studied
Interventions
- OTHER Placebo
- DRUG ADVAIR DISKUS™ 250/50mcg
Study Locations (20)
South Carolina
- GSK Investigational Site - Charleston
- GSK Investigational Site - Gaffney
- GSK Investigational Site - Greenville
- GSK Investigational Site - Spartanburg
Alabama
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Jasper
- GSK Investigational Site - Mobile
Missouri
- GSK Investigational Site - Chesterfield
- GSK Investigational Site - Saint Charles
- GSK Investigational Site - St Louis
California
- GSK Investigational Site - San Diego
- GSK Investigational Site - Torrance
Pennsylvania
- GSK Investigational Site - Downington
- GSK Investigational Site - Pittsburgh
Arizona
- GSK Investigational Site - Phoenix
Connecticut
- GSK Investigational Site - Hartford
Idaho
- GSK Investigational Site - Coeur d'Alene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 249 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-03 |
| Phase | Phase 4 |
What the finished NCT00857766 record still lists
NCT00857766 is an interventional study that assigns participants to a tested intervention. The registered 249 participants enrollment target is mid-sized for trials with a published cap, below the 1,041-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00857766 names 20 study sites across 11 states, led by South Carolina, Alabama, Missouri.
Frequently Asked Questions
What is clinical trial NCT00857766 about?
NCT00857766 is a clinical study titled "A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". The purpose of this study is to evaluate in patients with Chronic Obstructive Pulmonary Disease (COPD) if Advair DISKUS™ 250/50mcg BID modifies arterial stiffness which is a measure associated with risk of heart disease.
What is the current status of trial NCT00857766?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 249 participants. The study started on 2009-03. Estimated completion is 2010-03.
What conditions does trial NCT00857766 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT00857766?
The interventions under investigation include: Placebo (OTHER), ADVAIR DISKUS™ 250/50mcg (DRUG).
Who is sponsoring clinical trial NCT00857766?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00857766 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00857766's enrollment target sits among peer trials
249 42nd of 74 higher than 33 of 74 other Pulmonary Disease, Chronic Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Disease, Chronic Obstructive 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.
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