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NCT02730351 · ClinicalTrials.gov registry record · Phase 4
Crossover Study Comparing Fluticasone Furoate (FF)/Vilanterol (VI) Once Daily Versus Fluticasone Propionate (FP) Twice Daily in Subjects With Asthma and Exercise-Induced Bronchoconstriction (EIB)
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 75
- Enrollment target
NCT02730351 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 75 participants.
The verdict
NCT02730351, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, double-dummy, crossover study with two 2-week treatment periods separated by a 2-week wash-out period. Subjects will participate in up to eight study visits and have a follow up phone call approximately a week after the last clinic visit. Visits 1, 2, 3, 5 and 6 are evening visits that will be conducted between 5PM and 11PM. Visit 4 and Visit 7 are also evening visits that will begin between 5PM and 11PM and continue over a period of approximately 24 hours. Subjects will be required to attend three clinic visits during this 24-hour period. An exercise challenge (using a treadmill) will be conducted at Visit 2, Visit 3 and Visit 6 (after 23 hours of the first treatment dose in each Treatment Period); and at 12 and 23 hours post evening dose at Visits 4 and 7. Spirometry will be conducted at specified visits and prior to and after each exercise challenge. Subjects with symptomatic allergic rhinitis at Visit 1 (screening) may be treated for up to four weeks with intranasal corticosteroids followed by a repeat screening visit to determine eligibility prior to entry into the study. Eligible subjects at visit 1 will complete a 4-week single blind run-in on FP 250 microgram (mcg) twice daily (BID), followed by 2-week double-blind Treatment Period 1 on randomized treatment, a 2-week single blind washout period on FP 250 mcg BID, 2-week double-blind Treatment Period 2 receiving the alternative treatment, and follow-up contact approximately 7-days after completing Treatment Period 2. The total duration of study participation is approximately 11 weeks; and up to 15 weeks for subjects with Symptomatic Allergic Rhinitis. The primary objective of the study is to evaluate the protective effect of fluticasone furoate/vilanterol (FF/VI) 100/25 mcg once-daily compared with fluticasone propionate (FP) 250 mcg twice-daily against exercise-induced bronchoconstriction in adolescent and adult subjects aged 12 to 50 with persistent asthma
Interventions
- DRUG Fluticasone furoate/ Vilanterol 100 mcg/25 mcg
- DRUG Fluticasone propionate 250 mcg
- DRUG Placebo via ELLIPTA inhaler
- DRUG Placebo via DISKUS / ACCUHALER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2016-05-25 |
| Est. Completion | 2017-02-03 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02730351
The ClinicalTrials.gov registry entry for NCT02730351 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 75 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 4 interventions - of which Fluticasone furoate/ Vilanterol 100 mcg/25 mcg is the first listed.
NCT02730351 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02730351 about?
NCT02730351 is a clinical study titled "Crossover Study Comparing Fluticasone Furoate (FF)/Vilanterol (VI) Once Daily Versus Fluticasone Propionate (FP) Twice Daily in Subjects With Asthma and Exercise-Induced Bronchoconstriction (EIB)". This is a multicenter, randomized, double-blind, double-dummy, crossover study with two 2-week treatment periods separated by a 2-week wash-out period. Subjects will participate in up to eight study visits and have a follow up phone call approximately a week after the last clinic visit. Visits 1, 2,...
What is the current status of trial NCT02730351?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 75 participants. The study started on 2016-05-25. Estimated completion is 2017-02-03.
What interventions are being tested in trial NCT02730351?
The interventions under investigation include: Fluticasone furoate/ Vilanterol 100 mcg/25 mcg (DRUG), Fluticasone propionate 250 mcg (DRUG), Placebo via ELLIPTA inhaler (DRUG), Placebo via DISKUS / ACCUHALER (DRUG).
Who is sponsoring clinical trial NCT02730351?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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