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NCT01686633 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol (FF/VI) 200/25 Microgram (mcg) , FF/VI 100/25 mcg, and FF 100 mcg in Adults and Adolescents With Persistent Asthma.
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,040
- Enrollment target
NCT01686633: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01686633 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,040 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01686633, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,040 participants
- Enrollment target
Study Summary
This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study with three active comparators in subjects with moderate to severe persistent asthma. The study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and a follow up contact period of one week. The total duration of the study is 17 weeks. 990 subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF 100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects will be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for acute asthma symptoms throughout the entire study. Subjects will attend four on-treatment visits at Weeks 2, 4, 8, and 12 (Visits 4 through 7).
Primary Outcome
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 (within 30 minutes prior to dosing) and post-dose FEV1 measurements at 5, 15, and 30 minutes and at 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours on Day 84/Week 12. At each time point, the highest of three technically acceptable measurements was recorded. Change from Baseline was calculated as the weighted mean of the 24
Interventions
- DRUG Fluticasone Furoate/ Vilanterol 200/25 mcg
- DRUG Fluticasone Furoate/ Vilanterol 100/25 mcg
- DRUG Fluticasone Furoate 100 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,040 participants |
| Start Date | 2012-09-20 |
| Est. Completion | 2013-10-15 |
| Phase | Phase 3 |
What the finished NCT01686633 record still lists
NCT01686633 is an interventional study that assigns participants to a tested intervention. Its 1,040 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 3 interventions - of which Fluticasone Furoate/ Vilanterol 200/25 mcg is the first listed.
NCT01686633 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01686633 about?
NCT01686633 is a clinical study titled "An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol (FF/VI) 200/25 Microgram (mcg) , FF/VI 100/25 mcg, and FF 100 mcg in Adults and Adolescents With Persistent Asthma.". This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study with three active comparators in subjects with moderate to severe persistent asthma. The study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and a follow up contact peri...
What is the current status of trial NCT01686633?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,040 participants. The study started on 2012-09-20. Estimated completion is 2013-10-15.
What interventions are being tested in trial NCT01686633?
The interventions under investigation include: Fluticasone Furoate/ Vilanterol 200/25 mcg (DRUG), Fluticasone Furoate/ Vilanterol 100/25 mcg (DRUG), Fluticasone Furoate 100 mcg (DRUG).
Who is sponsoring clinical trial NCT01686633?
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 NCT01686633's enrollment target sits among peer trials
1,040 285th of 2000 higher than 1,714 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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