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NCT00452699 · ClinicalTrials.gov registry record · Phase 4
A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg BID To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg BID In Symptomatic Subjects With Asthma
A Phase 4 study of Asthma, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 621
- Enrollment target
- 20
- Study locations
NCT00452699: Completed Phase 4 study of Asthma, sponsored by GlaxoSmithKline.
NCT00452699 is a Phase 4 study of Asthma that has completed, run by GlaxoSmithKline. The registered enrollment target is 621 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00452699, a Phase 4 study of Asthma, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 621 participants
- Enrollment target
- 20
- Study locations
Study Summary
This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events
Primary Outcome
Pulmonary function was measured by forced expiratory volume in one second (FEV1), which is the volume of air exhaled from the lungs in one second. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.
Conditions Studied
Interventions
- DRUG Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID
- DRUG Fluticasone propionate 250 mcg BID
Study Locations (20)
California
- GSK Investigational Site - Fountain Valley
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Rancho Mirage
- GSK Investigational Site - Riverside
- GSK Investigational Site - San Jose
Florida
- GSK Investigational Site - Coral Gables
- GSK Investigational Site - Miami
- GSK Investigational Site - Pensacola
- GSK Investigational Site - Tallahassee
- GSK Investigational Site - Tamarac
Colorado
- GSK Investigational Site - Denver
- GSK Investigational Site - Denver
- GSK Investigational Site - Fort Collins
- GSK Investigational Site - Fort Collins
Georgia
- GSK Investigational Site - Columbus
- GSK Investigational Site - Conyers
- GSK Investigational Site - Lilburn
Arizona
- GSK Investigational Site - Scottsdale
Arkansas
- GSK Investigational Site - Little Rock
Connecticut
- GSK Investigational Site - Stamford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 621 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-05 |
| Phase | Phase 4 |
What the finished NCT00452699 record still lists
NCT00452699 is an interventional study that assigns participants to a tested intervention. The registered 621 participants enrollment target is mid-sized for trials with a published cap, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID is the first listed.
NCT00452699 names 20 study sites across 7 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT00452699 about?
NCT00452699 is a clinical study titled "A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg BID To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg BID In Symptomatic Subjects With Asthma". This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide...
What is the current status of trial NCT00452699?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 621 participants. The study started on 2007-05. Estimated completion is 2009-05.
What conditions does trial NCT00452699 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT00452699?
The interventions under investigation include: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID (DRUG), Fluticasone propionate 250 mcg BID (DRUG).
Who is sponsoring clinical trial NCT00452699?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00452699 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
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 NCT00452699's enrollment target sits among peer trials
621 67th of 374 higher than 308 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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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