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NCT00452348 · ClinicalTrials.gov registry record · Phase 4
A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg Twice Daily To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg Twice Daily In Symptomatic Patients With Asthma
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 628
- Enrollment target
NCT00452348: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT00452348 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 628 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (21% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00452348, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 628 participants
- Enrollment target
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.
Interventions
- DRUG Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID
- DRUG Fluticasone propionate 250 mcg BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 628 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-04 |
| Phase | Phase 4 |
What the finished NCT00452348 record still lists
NCT00452348 is an interventional study that assigns participants to a tested intervention. The registered 628 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (21% higher).
The record links to 0 conditions, and to 2 interventions - of which Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID is the first listed.
NCT00452348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00452348 about?
NCT00452348 is a clinical study titled "A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg Twice Daily To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg Twice Daily In Symptomatic Patients 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 NCT00452348?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 628 participants. The study started on 2007-05. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00452348?
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 NCT00452348?
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 NCT00452348's enrollment target sits among peer trials
628 130th of 2000 higher than 1,871 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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