Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate and Fluticasone Propionate in People With Asthma
A Randomised, Double-blind, Double-dummy, Placebo Controlled Multi-centre Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Inhalation Powder and Fluticasone Propionate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents Not Currently Treated With Inhaled Corticosteroids
1 other identifier
interventional
351
6 countries
42
Brief Summary
A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids
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 Sep 2011
Shorter than P25 for phase_3 asthma
42 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
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 15, 2011
CompletedFirst Posted
Study publicly available on registry
September 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
September 3, 2014
CompletedJanuary 9, 2017
November 1, 2016
1 year
September 15, 2011
August 21, 2014
November 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Clinic Visit 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. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were 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, pre-dose, 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 Over the 24-week Treatment Period
From Baseline up to Week 24
Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period
From Baseline up to Week 24
Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period
From Baseline up to Week 24
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 24-week Treatment Period
From Baseline up to Week 24
Number of Participants Who Withdrew Due to Lack of Efficacy During the 24-week Treatment Period
From the first dose of the study medication until Week 24/Early Withdrawal
Study Arms (3)
Fluticasone furoate 50 mcg
EXPERIMENTALOnce daily inhalation powder via Novel Dry Powder Inhaler
Fluticasone propionate 100mcg
ACTIVE COMPARATORTwice daily inhalation powder via DISKUS/ ACCUHALER
Placebo
PLACEBO COMPARATORInhalation Powder via Novel Dry Powder Inhaler and DISKUS/ ACCUHALER
Interventions
Once daily inhalation powder via Novel Dry Powder Inhaler
Twice daily inhalation powder via DISKUS/ACCUHALER
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Outpatient at least 12 years of age with a diagnosis of asthma at least 12 weeks prior to first visit
- Both genders; females of child bearing potential must be willing to use appropriate contraception during the study
- Pre-bronchodilator FEV1 of at least 60% predicted
- FEV1 reversibility of at least 12% and 200ml
- Current asthma therapy that includes a non-corticosteroid controller and/or short acting beta-agonist
You may not qualify if:
- History of life-threatening asthma exacerbation with the past 10 years
- Asthma exacerbation requiring oral corticosteroids within the past 3 months or overnight hospital stay within the past 6 months
- Current or recent respiratory infection or current oral candida infection
- Presence of a significant respiratory disease or other medical condition that is uncontrolled or that could affect subject safety or study outcome
- Known or suspected allergy to study medication or materials
- Taking another investigational medication or prohibited medication during the study
- Current smokers or former smokers with significant tobacco exposure
- Previous treatment with fluticasone furoate in a phase II or III study
- Children in Care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (42)
GSK Investigational Site
Los Angeles, California, 90025, United States
GSK Investigational Site
Rolling Hills Estates, California, 90274, United States
GSK Investigational Site
Sacramento, California, 95819, United States
GSK Investigational Site
San Jose, California, 95117, United States
GSK Investigational Site
Aventura, Florida, 33180, United States
GSK Investigational Site
Clearwater, Florida, 33756, United States
GSK Investigational Site
Hialeah, Florida, 33016, United States
GSK Investigational Site
Orlando, Florida, 32811, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
Sunset, Louisiana, 70584, United States
GSK Investigational Site
Bethesda, Maryland, 20814, United States
GSK Investigational Site
Columbia, Missouri, 65203, United States
GSK Investigational Site
Las Vegas, Nevada, 89119, United States
GSK Investigational Site
Brick, New Jersey, 08724, United States
GSK Investigational Site
Utica, New York, 13502, United States
GSK Investigational Site
Cincinnati, Ohio, 45242, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Corsicana, Texas, 75110, United States
GSK Investigational Site
El Paso, Texas, 79903, United States
GSK Investigational Site
Waco, Texas, 76712, United States
GSK Investigational Site
Guadalajara, Jalisco, 44100, Mexico
GSK Investigational Site
Zapopan, Jalisco, 45040, Mexico
GSK Investigational Site
Mexico City, 04530, Mexico
GSK Investigational Site
Almelo, 7609 PP, Netherlands
GSK Investigational Site
Eindhoven, 5623 EJ, Netherlands
GSK Investigational Site
Eindhoven, 5644 RX, Netherlands
GSK Investigational Site
Hoogwoud, 1718 BG, Netherlands
GSK Investigational Site
Zutphen, 7207 AE, Netherlands
GSK Investigational Site
Lima, Lima Province, Lima 1, Peru
GSK Investigational Site
Lima, Lima Province, Lima 27, Peru
GSK Investigational Site
San Miguel, Lima region, Lima 32, Peru
GSK Investigational Site
Lima, LIMA 29, Peru
GSK Investigational Site
Bydgoszcz, 85-046, Poland
GSK Investigational Site
Krakow, 31-159, Poland
GSK Investigational Site
Lodz, 93-329, Poland
GSK Investigational Site
Lublin, 20-552, Poland
GSK Investigational Site
Poznan, 60-693, Poland
GSK Investigational Site
Wroclaw, 50-088, Poland
GSK Investigational Site
Kemerovo, 650000, Russia
GSK Investigational Site
Moscow, 123182, Russia
GSK Investigational Site
Novosibirsk, 630087, Russia
GSK Investigational Site
Saint Petersburg, 194356, Russia
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
September 15, 2011
First Posted
September 19, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
January 9, 2017
Results First Posted
September 3, 2014
Record last verified: 2016-11
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.