Last updated: 11/07/2018 09:07:21
Clinical study evaluating safety and efficacy of fluticasone furoate and fluticasone propionate in people with asthmaN/A
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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 description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
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
Timeframe: Baseline and Week 24
Secondary outcomes:
Change from Baseline in the percentage of rescue-free 24-hour (hr) periods over the 24-week treatment period
Timeframe: From Baseline up to Week 24
Change from Baseline in daily evening (PM) peak expiratory flow (PEF) averaged over the 24-week treatment period
Timeframe: From Baseline up to Week 24
Change from Baseline in daily morning (AM) PEF averaged over the 24-week treatment period
Timeframe: 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
Timeframe: From Baseline up to Week 24
Number of participants who withdrew due to lack of efficacy during the 24-week treatment period
Timeframe: From the first dose of the study medication until Week 24/Early Withdrawal
Interventions:
Drug: Fluticasone furoate 50mcg
Drug: Fluticasone propionate 100mcg
Drug: Placebo
Enrollment:
351
Observational study model:
Not applicable
Primary completion date:
2012-26-09
Time perspective:
Not applicable
Clinical publications:
Busse W, Bateman E, O’Byrne P, Lötvall J, Woodcock A, Medley H, Forth R, Jacques L. Once-daily fluticasone furoate 50mcg in mild to moderate asthma: a 24-week placebo-controlled randomized trial. Allergy. 2014;69(11):1522-30.
Medical condition
Asthma
Product
fluticasone furoate, fluticasone propionate
Collaborators
Not applicable
Study date(s)
September 2011 to September 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Signed informed consent
- Outpatient at least 12 years of age with a diagnosis of asthma at least 12 weeks prior to first visit
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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
Trial location(s)
Location
GSK Investigational Site
Corsicana, Texas, United States, 75110
Status
Study Complete
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Brick, New Jersey, United States, 08724
Status
Study Complete
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20814
Status
Study Complete
Location
GSK Investigational Site
San Jose, California, United States, 95117
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32811
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
Status
Study Complete
Location
GSK Investigational Site
Columbia, Missouri, United States, 65203
Status
Study Complete
Location
GSK Investigational Site
Utica, New York, United States, 13502
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
Status
Study Complete
Location
GSK Investigational Site
Hialeah, Florida, United States, 33016
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95819
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45242
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33756
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90025
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-26-09
Actual study completion date
2012-26-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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