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NCT02924688 · ClinicalTrials.gov registry record · Phase 3
A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma
A Phase 3 study of Asthma, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,436
- Enrollment target
- 20
- Study locations
NCT02924688: Completed Phase 3 study of Asthma, sponsored by GlaxoSmithKline.
NCT02924688 is a Phase 3 study of Asthma that has completed, run by GlaxoSmithKline. The registered enrollment target is 2,436 participants, above the 1,557-participant average among 374 other Asthma trials with a reported enrollment target (56% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02924688, a Phase 3 study of Asthma, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,436 participants
- Enrollment target
- 20
- Study locations
Study Summary
A once-daily 'closed' triple FDC therapy of FF/UMEC/VI via a single ELLIPTA® dry powder inhaler (DPI) is being developed by GlaxoSmithKline (GSK) with the aim of providing a new treatment option for the management of asthma by improving lung function, health-related quality of life (HRQoL) and symptom control over established combination therapies. This is a phase III, multi-center, active-controlled, double-blind, parallel-group study to compare the efficacy, safety and tolerability of the FDC of FF/UMEC/VI with the FDC of FF/VI. This study has 5 phases: Pre-Screening (Visit 0), Screening/Run-in, Enrolment/Stabilization, Randomization/Treatment, and Follow up. At Visit 1 (Screening), subjects meeting all protocol defined inclusion/exclusion criteria will enter a 3-week run-in period and will receive fixed dose inhaled corticosteroid/long-acting beta agonist (ICS/LABA) (fluticasone/salmeterol, 250/50 micrograms (mcg), via the DISKUS® DPI) one inhalation twice a day. At Visit 2 (Enrolment), eligible subjects will be enrolled into the 2-week stabilization period to receive FF/VI (100/25 mcg via the ELLIPTA DPI once a day, in the morning). At the conclusion of the stabilization period (Visit 3), all subjects who meet the pre-defined randomization criteria will be randomized 1:1:1:1:1:1 during the treatment period to receive either FF/UMEC/VI (100/62.5/25 mcg; 200/62.5/25 mcg; 100/31.25/25 mcg; 200/31.25/25 mcg) or FF/VI (100/25 mcg; 200/25 mcg) via the ELLIPTA DPI once daily in the morning. The duration of the treatment period is variable but will be a minimum of 24 weeks and a maximum of 52 weeks. Subjects will have up to 6 on-treatment clinic visits scheduled at Visits 3, 4, 5, 6, 7 and 8/End of Study (EOS) (Weeks 0, 4, 12, 24, 36 and 52, respectively). A follow-up visit will be conducted approximately 7 days after the end of treatment period or, if applicable, after the early withdrawal visit. Subjects will be provided with short acting albuterol/salbutamol to be us
Primary Outcome
FEV1 is a measure of lung function and is defined as the maximal volume of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the highest FEV1 value obtained prior to the morning dose of investigational product. Baseline value is the last acceptable/borderline acceptable pre-dose FEV1 prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at Week 24 minus the Baseline value. Intent-to-Treat (ITT) Population comp
Conditions Studied
Interventions
- DRUG FF/UMEC/VI (100/31.25/25) mcg
- DRUG FF/UMEC/VI (100/62.5/25) mcg
- DRUG FF/UMEC/VI (200/31.25/25) mcg
- DRUG FF/UMEC/VI (200/62.5/25) mcg
- DRUG FF/VI (100/25) mcg
Study Locations (20)
California
- GSK Investigational Site - Canton
- GSK Investigational Site - Encinitas
- GSK Investigational Site - Escondico
- GSK Investigational Site - Huntington Beach
- GSK Investigational Site - Huntington Beach
- GSK Investigational Site - La Jolla
- GSK Investigational Site - Long Beach
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Oxnard
- GSK Investigational Site - Rolling Hills Estates
- GSK Investigational Site - Roseville
- GSK Investigational Site - San Diego
- GSK Investigational Site - San Diego
Alabama
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Mobile
- GSK Investigational Site - Montgomery
Arizona
- GSK Investigational Site - Gilbert
- GSK Investigational Site - Scottsdale
- GSK Investigational Site - Tucson
Arkansas
- GSK Investigational Site - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,436 participants |
| Start Date | 2016-10-13 |
| Est. Completion | 2019-02-22 |
| Phase | Phase 3 |
What the finished NCT02924688 record still lists
NCT02924688 is an interventional study that assigns participants to a tested intervention. Its 2,436 participants enrollment target places it among the larger protocols in the corpus, above the 1,557-participant average among 374 other Asthma trials with a reported enrollment target (56% higher).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 5 interventions - of which FF/UMEC/VI (100/31.25/25) mcg is the first listed.
NCT02924688 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT02924688 about?
NCT02924688 is a clinical study titled "A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma". A once-daily 'closed' triple FDC therapy of FF/UMEC/VI via a single ELLIPTA® dry powder inhaler (DPI) is being developed by GlaxoSmithKline (GSK) with the aim of providing a new treatment option for the management of asthma by improving lung function, health-related quality of life (HRQoL) and sympt...
What is the current status of trial NCT02924688?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,436 participants. The study started on 2016-10-13. Estimated completion is 2019-02-22.
What conditions does trial NCT02924688 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT02924688?
The interventions under investigation include: FF/UMEC/VI (100/31.25/25) mcg (DRUG), FF/UMEC/VI (100/62.5/25) mcg (DRUG), FF/UMEC/VI (200/31.25/25) mcg (DRUG), FF/UMEC/VI (200/62.5/25) mcg (DRUG), FF/VI (100/25) mcg (DRUG).
Who is sponsoring clinical trial NCT02924688?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02924688 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02924688's enrollment target sits among peer trials
2,436 22nd of 374 higher than 353 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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.
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