Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents
A Randomised, Double-blind, Double-dummy, Placebo Controlled (With Rescue Medication), Multicenter Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents.
1 other identifier
interventional
350
5 countries
82
Brief Summary
A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Jun 2010
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2010
CompletedFirst Submitted
Initial submission to the registry
July 8, 2010
CompletedFirst Posted
Study publicly available on registry
July 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2012
CompletedResults Posted
Study results publicly available
August 8, 2013
CompletedNovember 9, 2017
October 1, 2017
1.5 years
July 8, 2010
June 6, 2013
October 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Clinic Visit Trough Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24 Week Treatment Period
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the clinic visit at the end of the dosing interval. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.
Baseline and Week 24
Secondary Outcomes (5)
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods at the End of the 24-week Treatment Period
Baseline and Week 24
Mean Change From Baseline in Daily Trough Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period
From Baseline up to Week 12 and Week 24
Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period
From Baseline up to Week 12 and Week 24
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods at the End of the 24-week Treatment Period
Baseline and Week 24
Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24
Baseline, Week 12, and Week 24
Study Arms (3)
Fluticasone Furoate OD and Placebo BID
EXPERIMENTALFluticasone furoate inhalation powder once daily and placebo inhalation powder twice daily for 24 weeks
Fluticasone Propionate BID and Placebo OD
ACTIVE COMPARATORFluticasone propionate inhalation powder twice daily and placebo inhalation powder once daily for 24 weeks
Placebo only BID
PLACEBO COMPARATORPlacebo inhalation powder twice daily for 24 weeks
Interventions
Fluticasone propionate inhalation powder, 250 µg
Fluticasone furoate inhalation powder, 100 µg
Placebo inhalation powder
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Outpatient at least 12 years of age
- Both genders; females of child bearing potential must be willing to use approved birth control method
- Pre-bronchodilator FEV1 of 40-90% predicted
- Reversibility FEV1 of at least 12% and 200mLs
- Current asthma therapy that includes an inhaled corticosteroid for at least 4 weeks prior to first visit
You may not qualify if:
- History of life threatening asthma
- Respiratory infection or candidiasis
- Asthma exacerbation within 6 months prior to first visit
- Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
- Allergies to study drugs, study drug excipients, medications related to study drugs
- Taking another investigational medication or medication prohibited for use during this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (82)
GSK Investigational Site
Birmingham, Alabama, 35209, United States
GSK Investigational Site
Montgomery, Alabama, 36106, United States
GSK Investigational Site
Green Valley, Arizona, 85614, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Bakersfield, California, 93301, United States
GSK Investigational Site
Encinitas, California, 92024, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
Long Beach, California, 90813, United States
GSK Investigational Site
Newport Beach, California, 92663, United States
GSK Investigational Site
Orange, California, 92868, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Rolling Hills Estates, California, 90274, United States
GSK Investigational Site
San Diego, California, 92103-8415, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
San Diego, California, 92128, United States
GSK Investigational Site
San Jose, California, 95117, United States
GSK Investigational Site
Cutler Bay, Florida, 33189, United States
GSK Investigational Site
Edgewater, Florida, 32132, United States
GSK Investigational Site
Miami, Florida, 33155, United States
GSK Investigational Site
Miami, Florida, 33185, United States
GSK Investigational Site
Orlando, Florida, 32806, United States
GSK Investigational Site
Albany, Georgia, 31707, United States
GSK Investigational Site
Columbus, Georgia, 31904, United States
GSK Investigational Site
Shiloh, Illinois, 62269, United States
GSK Investigational Site
Lenexa, Kansas, 66215, United States
GSK Investigational Site
Owensboro, Kentucky, 42301, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
Sunset, Louisiana, 70584, United States
GSK Investigational Site
Baltimore, Maryland, 21236, United States
GSK Investigational Site
Columbia, Missouri, 65203, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Bellevue, Nebraska, 68123-4303, United States
GSK Investigational Site
Las Vegas, Nevada, 89119, United States
GSK Investigational Site
Shelby, North Carolina, 28152, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Dayton, Ohio, 45459, United States
GSK Investigational Site
Franklin, Ohio, 45005, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Collegeville, Pennsylvania, 19426, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Greenville, South Carolina, 29607, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Austin, Texas, 78750, United States
GSK Investigational Site
Dallas, Texas, 75225, United States
GSK Investigational Site
Houston, Texas, 77054, United States
GSK Investigational Site
Kerrville, Texas, 78028, United States
GSK Investigational Site
San Antonio, Texas, 78224, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
San Antonio, Texas, 78251, United States
GSK Investigational Site
Waco, Texas, 76712, United States
GSK Investigational Site
Richmond, Virginia, 23225, United States
GSK Investigational Site
Gozée, 6534, Belgium
GSK Investigational Site
Halen, 3544, Belgium
GSK Investigational Site
Natoye, 5360, Belgium
GSK Investigational Site
Tremelo, 3120, Belgium
GSK Investigational Site
Rüdersdorf, Brandenburg, 15562, Germany
GSK Investigational Site
Schwedt, Brandenburg, 16303, Germany
GSK Investigational Site
Eschwege, Hesse, 37269, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30173, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112, Germany
GSK Investigational Site
Erfurt, Thuringia, 99084, Germany
GSK Investigational Site
Schmölln, Thuringia, 04626, Germany
GSK Investigational Site
Berlin, 10367, Germany
GSK Investigational Site
Berlin, 12043, Germany
GSK Investigational Site
Berlin, 12157, Germany
GSK Investigational Site
Dębica, 39-200, Poland
GSK Investigational Site
Kielce, 25-751, Poland
GSK Investigational Site
Lodz, 93-513, Poland
GSK Investigational Site
Sopot, 81-741, Poland
GSK Investigational Site
Szczecin, 71-124, Poland
GSK Investigational Site
Łomża, 18-400, Poland
GSK Investigational Site
Bucharest, 020125, Romania
GSK Investigational Site
Bucharest, 022102, Romania
GSK Investigational Site
Bucharest, 041914, Romania
GSK Investigational Site
Bucharest, 050042, Romania
GSK Investigational Site
Bucharest, 050526, Romania
GSK Investigational Site
Iași, 700115, Romania
Related Publications (1)
O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.
PMID: 27881132DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2010
First Posted
July 12, 2010
Study Start
June 30, 2010
Primary Completion
January 1, 2012
Study Completion
January 16, 2012
Last Updated
November 9, 2017
Results First Posted
August 8, 2013
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.