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NCT01086410 · ClinicalTrials.gov registry record · Phase 3
Safety Study of the Effects of Inhaled Fluticasone Furoate/GW642444 on the Hypothalamic-Pituitary-Adrenal (HPA) Axis
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 185
- Enrollment target
NCT01086410: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01086410 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 185 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01086410, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 185 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effect of six weeks' treatment with two once-daily strengths of Fluticasone Furoate/GW642444 Inhalation Powder on the HPA axis system
Primary Outcome
Serum cortisol weighted mean was determined for each participant over the time period 0-12 hours on Day -1/1 (Baseline) and Day 42. Serum cortisol weighted mean was derived by dividing the area under the concentration-time curve (AUC; defined as thearea under the concentration-time curve from time zero up to 24 hours) by the sample collection time interval. The sample collection time interval is defined as the difference between the time of the last cortisol sample and the time of the first cort
Interventions
- DRUG Placebo Oral Capsule
- DRUG Placebo Inhalation Powder
- DRUG Fluticasone Furoate/GW642444 Inhalation Powder
- DRUG Prednisolone Oral Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2010-03 |
| Est. Completion | 2010-09 |
| Phase | Phase 3 |
What the finished NCT01086410 record still lists
NCT01086410 is an interventional study that assigns participants to a tested intervention. The registered 185 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 (76% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo Oral Capsule is the first listed.
NCT01086410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01086410 about?
NCT01086410 is a clinical study titled "Safety Study of the Effects of Inhaled Fluticasone Furoate/GW642444 on the Hypothalamic-Pituitary-Adrenal (HPA) Axis". The purpose of this study is to assess the effect of six weeks' treatment with two once-daily strengths of Fluticasone Furoate/GW642444 Inhalation Powder on the HPA axis system
What is the current status of trial NCT01086410?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 185 participants. The study started on 2010-03. Estimated completion is 2010-09.
What interventions are being tested in trial NCT01086410?
The interventions under investigation include: Placebo Oral Capsule (DRUG), Placebo Inhalation Powder (DRUG), Fluticasone Furoate/GW642444 Inhalation Powder (DRUG), Prednisolone Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT01086410?
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 NCT01086410's enrollment target sits among peer trials
185 1417th of 2000 higher than 583 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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