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NCT00441441 · ClinicalTrials.gov registry record · Phase 3
A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 351
- Enrollment target
NCT00441441: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00441441 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 351 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00441441, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 351 participants
- Enrollment target
Study Summary
This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed.
Primary Outcome
Adverse Events reported by the Investigator and judged by the Investigator to be possibly related to study drug, categorized by the Medical Dictionary for Regulatory Activities (MeDRA), were reported. ECG, electrocardiogram. QTc (corrected QT interval) and QT represent intervals on an ECG.
Interventions
- DRUG fluticasone propionate
- DRUG fluticasone propionate/salmeterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 351 participants |
| Start Date | 2007-02 |
| Est. Completion | 2008-01 |
| Phase | Phase 3 |
What the finished NCT00441441 record still lists
NCT00441441 is an interventional study that assigns participants to a tested intervention. The registered 351 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which fluticasone propionate is the first listed.
NCT00441441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00441441 about?
NCT00441441 is a clinical study titled "A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma". This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed.
What is the current status of trial NCT00441441?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 351 participants. The study started on 2007-02. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00441441?
The interventions under investigation include: fluticasone propionate (DRUG), fluticasone propionate/salmeterol (DRUG).
Who is sponsoring clinical trial NCT00441441?
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 NCT00441441's enrollment target sits among peer trials
351 1033rd of 2000 higher than 967 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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