Last updated: 11/07/2018 09:06:00
Clinical study evaluating safety and efficacy of fluticasone furoate in people with asthmaN/A
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids
Trial description: A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not currently receiving 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 12-week treatment period
Timeframe: Baseline and Week 12
Secondary outcomes:
Change from Baseline in the percentage of rescue-free 24-hour (hr) periods over the 12-week treatment period
Timeframe: From Baseline up to Week 12
Change from Baseline in daily evening (PM) peak expiratory flow (PEF) averaged over the 12-week treatment period
Timeframe: From Baseline up to Week 12
Change from Baseline in daily morning (AM) PEF averaged over the 12-week treatment period
Timeframe: From Baseline up to Week 12
Change from Baseline in the percentage of symptom-free 24-hour (hr) periods over the 12-week treatment period
Timeframe: From Baseline up to Week 12
Number of participants who withdrew due to a lack of efficacy during the 12-week treatment period
Timeframe: From the first dose of the study medication until Week 12/Early Withdrawal
Interventions:
Drug: Fluticasone furoate 50mcg
Drug: Placebo
Enrollment:
248
Observational study model:
Not applicable
Primary completion date:
2012-07-08
Time perspective:
Not applicable
Clinical publications:
O'Byrne PM, Woodcock A, Bleecker ER, Bateman ED, Lötvall J, Forth R, Medley H, Jacques L, Busse WW. Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial. Respir Res. 2014;15(1):88.
Svedsater H, Jacques L, Goldfrad C, Bleecker ER.Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma.npj Primary Care Respiratory Medicine.2014;24:14019
Medical condition
Asthma
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
September 2011 to August 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 diagnosis of asthma at least 12 weeks before first visit
- History of life-threatening asthma exacerbation within the past 10 years
- Asthma exacerbation requiring treatment with oral corticosteroids within the last 3 months or that required overnight hospital stay within 6 months
Inclusion and exclusion criteria
Inclusion criteria:
- Signed informed consent
- Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks before 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 200mls
- Current asthma therapy that includes a non-corticosteroid controller and/or short-acting beta agonist
Exclusion criteria:
- History of life-threatening asthma exacerbation within the past 10 years
- Asthma exacerbation requiring treatment with oral corticosteroids within the last 3 months or that required overnight hospital stay within 6 months
- Current or recent respiratory infection or current oral candida infection
- Presence of another significant respiratory disease or medical condition that is not controlled or that could affect subject safety or study outcome
- Known or suspected allergy to study drug or materials
- Taking another investigational medication or prohibited medication during the study
- Previous treatment with inhaled fluticasone furoate in a phase II or III study
- Current smokers or former smokers with significant tobacco exposure
- Children in Care
Trial location(s)
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Newport Beach, California, United States, 92663
Status
Study Complete
Location
GSK Investigational Site
Columbia, Missouri, United States, 65203
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90808
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90025
Status
Study Complete
Location
GSK Investigational Site
Albany, Georgia, United States, 31707
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Corsicana, Texas, United States, 75110
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
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
2012-07-08
Actual study completion date
2012-07-08
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.
Additional information about the trial
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