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NCT01462344 · ClinicalTrials.gov registry record · Phase 4
6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 6,250
- Enrollment target
NCT01462344: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT01462344 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 6,250 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1107% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01462344, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 6,250 participants
- Enrollment target
Study Summary
The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.
Primary Outcome
Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a \>=24-hour stay in an observation area in an emergency department or other equivalent facility. Time to first event in the composite endpoint of serious asthma-related outcom
Interventions
- DRUG ADVAIR 100/50mcg
- DRUG ADVAIR 250/50mcg
- DRUG FLOVENT 100mcg
- DRUG FLOVENT 250mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,250 participants |
| Start Date | 2011-11-17 |
| Est. Completion | 2015-11-03 |
| Phase | Phase 4 |
What the finished NCT01462344 record still lists
NCT01462344 is an interventional study that assigns participants to a tested intervention. Its 6,250 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1107% higher).
The record links to 0 conditions, and to 4 interventions - of which ADVAIR 100/50mcg is the first listed.
NCT01462344 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01462344 about?
NCT01462344 is a clinical study titled "6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old". The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone pro...
What is the current status of trial NCT01462344?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 6,250 participants. The study started on 2011-11-17. Estimated completion is 2015-11-03.
What interventions are being tested in trial NCT01462344?
The interventions under investigation include: ADVAIR 100/50mcg (DRUG), ADVAIR 250/50mcg (DRUG), FLOVENT 100mcg (DRUG), FLOVENT 250mcg (DRUG).
Who is sponsoring clinical trial NCT01462344?
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 NCT01462344's enrollment target sits among peer trials
6,250 12th of 2000 higher than 1,989 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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