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NCT00118716 · ClinicalTrials.gov registry record · Phase 4
A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 248
- Enrollment target
NCT00118716: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT00118716 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 248 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00118716, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 248 participants
- Enrollment target
Study Summary
During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.
Primary Outcome
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Maximal percent change in FEV1 following exercise challenge was defined as the percent change from pre-exercise baseline FEV1 to the minimum FEV1 collected within one hour following exercise challenge. Maximal percent change in FEV1 following exercise challenge was mean maximal percent change from pre-exercise baseline compared between treatment groups at Treatment Week 4.
Interventions
- DRUG Fluticasone propionate/salmeterol
- DRUG Fluticasone Propionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2003-12-23 |
| Est. Completion | 2006-04-23 |
| Phase | Phase 4 |
What the finished NCT00118716 record still lists
NCT00118716 is an interventional study that assigns participants to a tested intervention. The registered 248 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 (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Fluticasone propionate/salmeterol is the first listed.
NCT00118716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00118716 about?
NCT00118716 is a clinical study titled "A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise". During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung...
What is the current status of trial NCT00118716?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 248 participants. The study started on 2003-12-23. Estimated completion is 2006-04-23.
What interventions are being tested in trial NCT00118716?
The interventions under investigation include: Fluticasone propionate/salmeterol (DRUG), Fluticasone Propionate (DRUG).
Who is sponsoring clinical trial NCT00118716?
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 NCT00118716's enrollment target sits among peer trials
248 353rd of 2000 higher than 1,646 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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