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NCT01453023 · ClinicalTrials.gov registry record · Phase 2
Inhaled Fluticasone Furoate/Vilanterol Safety and Tolerability, PK and PD Study
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT01453023: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01453023 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01453023, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
This study will investigate the safety and tolerability, pharmacokinetics, and pharmacodynamics of fluticasone furoate/vilanterol (FF/VI) 100/25mcg administered using the novel dry powder inhaler in children aged 5 to 11 years with persistent asthma.
Primary Outcome
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth de
Interventions
- DRUG Fluticasone Furoate/Vilanterol
- DRUG Fluticasone Furoate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
What the finished NCT01453023 record still lists
NCT01453023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Fluticasone Furoate/Vilanterol is the first listed.
NCT01453023 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01453023 about?
NCT01453023 is a clinical study titled "Inhaled Fluticasone Furoate/Vilanterol Safety and Tolerability, PK and PD Study". This study will investigate the safety and tolerability, pharmacokinetics, and pharmacodynamics of fluticasone furoate/vilanterol (FF/VI) 100/25mcg administered using the novel dry powder inhaler in children aged 5 to 11 years with persistent asthma.
What is the current status of trial NCT01453023?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2011-10. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01453023?
The interventions under investigation include: Fluticasone Furoate/Vilanterol (DRUG), Fluticasone Furoate (DRUG).
Who is sponsoring clinical trial NCT01453023?
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 NCT01453023's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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