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NCT01475721 · ClinicalTrials.gov registry record · Phase 4
SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 11,751
- Enrollment target
NCT01475721: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT01475721 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 11,751 participants, above the 517-participant average among 9,235 other Phase 4 trials with a reported enrollment target (2173% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01475721, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11,751 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 adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone. ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.
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. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ra
Interventions
- DRUG ADVAIR 100/50mcg
- DRUG ADVAIR 250/50mcg
- DRUG FLOVENT 100mcg
- DRUG FLOVENT 250mcg
- DRUG ADVAIR 500/50mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11,751 participants |
| Start Date | 2011-11-18 |
| Est. Completion | 2015-06-23 |
| Phase | Phase 4 |
What the finished NCT01475721 record still lists
NCT01475721 is an interventional study that assigns participants to a tested intervention. Its 11,751 participants enrollment target places it among the larger protocols in the corpus, above the 517-participant average among 9,235 other Phase 4 trials with a reported enrollment target (2173% higher).
The record links to 0 conditions, and to 5 interventions - of which ADVAIR 100/50mcg is the first listed.
NCT01475721 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01475721 about?
NCT01475721 is a clinical study titled "SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.". The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those tak...
What is the current status of trial NCT01475721?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11,751 participants. The study started on 2011-11-18. Estimated completion is 2015-06-23.
What interventions are being tested in trial NCT01475721?
The interventions under investigation include: ADVAIR 100/50mcg (DRUG), ADVAIR 250/50mcg (DRUG), FLOVENT 100mcg (DRUG), FLOVENT 250mcg (DRUG), ADVAIR 500/50mcg (DRUG).
Who is sponsoring clinical trial NCT01475721?
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 NCT01475721's enrollment target sits among peer trials
11,751 7th of 2000 higher than 1,994 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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