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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,040 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01686633
The ClinicalTrials.gov registry entry for NCT01686633 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,040 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Fluticasone Furoate/ Vilanterol 200/25 mcg is the first listed.
NCT01686633 reports 0 study locations.
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.
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