Last updated: 11/07/2018 04:22:29
Evaluating the efficacy and safety of Fluticasone Furoate Inhalation Powder in the treatment of asthma in adults and adolescentsn/a
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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 description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
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
Timeframe: Baseline and Week 24
Secondary outcomes:
Change from Baseline in the percentage of rescue-free 24-hour (hr) periods at the end of the 24-week Treatment Period
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Baseline and Week 24
Change from Baseline in the total Asthma Quality of Life Questionnaire (AQLQ) (+12) score at Week 12 and Week 24
Timeframe: Baseline, Week 12, and Week 24
Interventions:
Drug: Fluticasone propionate
Drug: Fluticasone furoate
Drug: Placebo
Enrollment:
350
Observational study model:
Not applicable
Primary completion date:
2012-16-01
Time perspective:
Not applicable
Clinical publications:
Lötvall J, Bleecker ER, Busse WW, O’Byrne PM, Woodcock A, Kerwin EM, Stone S, Forth R, Jacques L, Bateman ED. Efficacy and safety of fluticasone furoate 100µg once-daily in patients with persistent asthma: a 24-week placebo and active-controlled randomised trial. Respir Med. 2014;108(1):41-9.
Medical condition
Asthma
Product
fluticasone furoate, fluticasone propionate
Collaborators
Not applicable
Study date(s)
June 2010 to January 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
- History of life threatening asthma
- Respiratory infection or candidiasis
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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
Trial location(s)
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Shelby, North Carolina, United States, 28152
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
Columbia, Missouri, United States, 65203
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Owensboro, Kentucky, United States, 42301
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90813
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78251
Status
Study Complete
Location
GSK Investigational Site
San Jose, California, United States, 95117
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32806
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103-8415
Status
Study Complete
Location
GSK Investigational Site
Newport Beach, California, United States, 92663
Status
Study Complete
Location
GSK Investigational Site
Green Valley, Arizona, United States, 85614
Status
Study Complete
Location
GSK Investigational Site
Columbus, Georgia, United States, 31904
Status
Study Complete
Location
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Ruedersdorf, Brandenburg, Germany, 15562
Status
Study Complete
Location
GSK Investigational Site
Bakerfield, California, United States, 93301
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78224
Status
Study Complete
Location
GSK Investigational Site
Edgewater, Florida, United States, 32132
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21236
Status
Study Complete
Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92128
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30173
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29607
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Collegeville, Pennsylvania, United States, 19426
Status
Study Complete
Location
GSK Investigational Site
Kerrville, Texas, United States, 78028
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Bellevue, Nebraska, United States, 68123-4303
Status
Study Complete
Location
GSK Investigational Site
Encinitas, California, United States, 92024
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23225
Status
Study Complete
Location
GSK Investigational Site
Shiloh, Illinois, United States, 62269
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90808
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Montgomery, Alabama, United States, 36106
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
Status
Study Complete
Location
GSK Investigational Site
Cutler Bay, Florida, United States, 33189
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
2012-16-01
Actual study completion date
2012-16-01
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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