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
Public ClinicalTrials.gov record NCT02301975. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Double-dummy, Parallel Group, Multicenter Study of Once Daily Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, Twice Daily Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Twice Daily Fluticasone Propionate 250 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents Already Adequately Controlled on Twice-daily Inhaled Corticosteroid and Long-acting beta2 Agonist
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02301975
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,526 participants
Conditions and interventions
Conditions
Interventions
- 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
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 1, 2015 (Type not available)
- Primary completion
- Nov 1, 2016 (Actual)
- Completion
- Nov 25, 2016 (Actual)
- Last update posted
- Aug 6, 2018
2015 – 2016
United States locations
- U.S. sites
- 34
- U.S. states
- 16
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Huntington Beach | California | 92647 | — |
| GSK Investigational Site | Riverside | California | 92506 | — |
| GSK Investigational Site | Rolling Hills Estates | California | 90274 | — |
| GSK Investigational Site | San Diego | California | 92103 | — |
| GSK Investigational Site | Upland | California | 91786 | — |
| GSK Investigational Site | Denver | Colorado | 80230 | — |
| GSK Investigational Site | Miami | Florida | 33165 | — |
| GSK Investigational Site | Miami | Florida | 33174 | — |
| GSK Investigational Site | Albany | Georgia | 31707 | — |
| GSK Investigational Site | Baltimore | Maryland | 21236 | — |
| GSK Investigational Site | Columbia | Maryland | 21044 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55402 | — |
| GSK Investigational Site | Plymouth | Minnesota | 55441 | — |
| GSK Investigational Site | Columbia | Missouri | 65203 | — |
| GSK Investigational Site | Rolla | Missouri | 65401 | — |
| GSK Investigational Site | Bellevue | Nebraska | 68123-4303 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28277 | — |
| GSK Investigational Site | Gastonia | North Carolina | 28054 | — |
| GSK Investigational Site | Hendersonville | North Carolina | 28739 | — |
| GSK Investigational Site | Huntersville | North Carolina | 28078 | — |
| GSK Investigational Site | Canton | Ohio | 44718 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | — |
| GSK Investigational Site | Middleburg Heights | Ohio | 44130 | — |
| GSK Investigational Site | Medford | Oregon | 97504 | — |
| GSK Investigational Site | Bethlehem | Pennsylvania | 18020 | — |
| GSK Investigational Site | Greenville | South Carolina | 29615 | — |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | — |
| GSK Investigational Site | Rock Hill | South Carolina | 29732 | — |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | — |
| GSK Investigational Site | Austin | Texas | 78750 | — |
| GSK Investigational Site | Lewisville | Texas | 75067 | — |
| GSK Investigational Site | Waco | Texas | 76712 | — |
| GSK Investigational Site | Richmond | Virginia | 23225 | — |
| GSK Investigational Site | Greenfield | Wisconsin | 53228 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 145 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02301975, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 6, 2018 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02301975 live on ClinicalTrials.gov.