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NCT02301975 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma
A Phase 3 study of Asthma, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,526
- Enrollment target
- 20
- Study locations
NCT02301975: Completed Phase 3 study of Asthma, sponsored by GlaxoSmithKline.
NCT02301975 is a Phase 3 study of Asthma that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,526 participants, roughly in line with the 1,559-participant average among 374 other Asthma trials with a reported enrollment target. The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02301975, a Phase 3 study of Asthma, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,526 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticasone propionate \[FP\]/salmeterol 250/50 microgram \[mcg\]twice daily \[BD\]), either via a fixed dose combination product or through separate inhalers. The study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by a treatment period of 24 weeks, and a follow up contact period of one week. The total duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately controlled on a twice-daily ICS/LABA. SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group of Companies.
Primary Outcome
FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint a
Conditions Studied
Interventions
- DRUG Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler
- DRUG Placebo inhalation powders via ELLIPTA inhaler
- DRUG Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler
- DRUG Placebo inhalation powder via ACCUHALER/DISKUS inhaler
- DRUG Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler
Study Locations (20)
California
- GSK Investigational Site - Huntington Beach
- GSK Investigational Site - Riverside
- GSK Investigational Site - Rolling Hills Estates
- GSK Investigational Site - San Diego
- GSK Investigational Site - Upland
North Carolina
- GSK Investigational Site - Charlotte
- GSK Investigational Site - Gastonia
- GSK Investigational Site - Hendersonville
- GSK Investigational Site - Huntersville
Florida
- GSK Investigational Site - Miami
- GSK Investigational Site - Miami
Maryland
- GSK Investigational Site - Baltimore
- GSK Investigational Site - Columbia
Minnesota
- GSK Investigational Site - Minneapolis
- GSK Investigational Site - Plymouth
Missouri
- GSK Investigational Site - Columbia
- GSK Investigational Site - Rolla
Colorado
- GSK Investigational Site - Denver
Georgia
- GSK Investigational Site - Albany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,526 participants |
| Start Date | 2015-03-01 |
| Est. Completion | 2016-11-25 |
| Phase | Phase 3 |
What the finished NCT02301975 record still lists
NCT02301975 is an interventional study that assigns participants to a tested intervention. Its 1,526 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,559-participant average among 374 other Asthma trials with a reported enrollment target.
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 5 interventions - of which Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler is the first listed.
NCT02301975 names 20 study sites across 9 states, led by California, North Carolina, Florida.
Frequently Asked Questions
What is clinical trial NCT02301975 about?
NCT02301975 is a clinical study titled "An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma". This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticason...
What is the current status of trial NCT02301975?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,526 participants. The study started on 2015-03-01. Estimated completion is 2016-11-25.
What conditions does trial NCT02301975 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT02301975?
The interventions under investigation include: Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler (DRUG), Placebo inhalation powders via ELLIPTA inhaler (DRUG), Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler (DRUG), Placebo inhalation powder via ACCUHALER/DISKUS inhaler (DRUG), Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler (DRUG).
Who is sponsoring clinical trial NCT02301975?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02301975 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02301975's enrollment target sits among peer trials
1,526 25th of 374 higher than 350 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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