EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma
Trial description: This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of participants with 1 or more severe asthma exacerbations
Timeframe: Baseline to Follow-up (up to 76 weeks of treatment)
Secondary outcomes:
Number of severe asthma exacerbations
Timeframe: Baseline to Follow-up (up to 76 weeks of treatment)
Change from Baseline in evening pre-dose trough FEV1 at Week 36
Timeframe: Baseline and Week 36
Interventions:
Drug: Fluticasone Furoate/GW642444
Drug: Fluticasone furoate
Enrollment:
2020
Observational study model:
Not applicable
Primary completion date:
2011-15-09
Time perspective:
Not applicable
Clinical publications:
Bateman ED, O’Byrne PM, Busse WW, Lötvall J, Bleecker ER, Andersen L, Jacques L, Frith L, Lim J, Woodcock A. Once-daily fluticasone furoate (FF)/vilanterol reduces risk of severe exacerbations in asthma versus FF alone. Thorax. 2014;69(4):312-9.
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
February 2010 to September 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Clinical diagnosis of asthma
- Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
- History of life threatening asthma in previous 5 years (requiring intubation, and/or associated with hypercapnia, hypoxic seizure or respiratory arrest
- Respiratory infection or oral candidiasis
Inclusion and exclusion criteria
Inclusion criteria:
- Clinical diagnosis of asthma -Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
- FEV1 of fifty to ninety percent of predicted
- Currently using inhaled corticosteroid therapy
- History of one or more asthma exacerbations requiring treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization in previous year
Exclusion criteria:
- History of life threatening asthma in previous 5 years (requiring intubation, and/or associated with hypercapnia, hypoxic seizure or respiratory arrest
- Respiratory infection or oral candidiasis
- Uncontrolled disease or clinical abnormality
- Allergies
- Taking another investigational medication or prohibited medication
Trial location(s)
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Status
Study Complete
Location
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93721
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85016
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
Status
Study Complete
Location
GSK Investigational Site
Solingen, Nordrhein-Westfalen, Germany, 42651
Status
Study Complete
Location
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
Status
Study Complete
Location
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2606
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
Status
Study Complete
Location
GSK Investigational Site
Columbus, Georgia, United States, 31904
Status
Study Complete
Location
GSK Investigational Site
Winter Park, Florida, United States, 32789
Status
Study Complete
Location
GSK Investigational Site
Rancho Mirage, California, United States, 92270
Status
Study Complete
Location
GSK Investigational Site
La Crosse, Wisconsin, United States, 54601
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Tucson, Arizona, United States, 85724-5073
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80230
Status
Study Complete
Location
GSK Investigational Site
Bell Gardens, California, United States, 90201
Status
Study Complete
Location
GSK Investigational Site
Bellingham, Washington, United States, 98225
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19115
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21236
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58452
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90808
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
Status
Study Complete
Location
GSK Investigational Site
Owensboro, Kentucky, United States, 42301
Status
Study Complete
Location
GSK Investigational Site
Toorak Gardens, South Australia, Australia, 5065
Status
Study Complete
Location
GSK Investigational Site
Monterrey NL, Nuevo León, Mexico, 64718
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000DSR
Status
Study Complete
Location
GSK Investigational Site
Lawrenceville, Georgia, United States, 30046
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Study Complete
Location
GSK Investigational Site
Parana, Entre Ríos, Argentina, E3100BHK
Status
Study Complete
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Study Complete
Location
GSK Investigational Site
Ruedersdorf, Brandenburg, Germany, 15562
Status
Study Complete
Location
GSK Investigational Site
Auchenflower, Queensland, Australia, 4066
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44787
Status
Study Complete
Location
GSK Investigational Site
Rockville Center, New York, United States, 11570
Status
Study Complete
Location
GSK Investigational Site
Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Hornsby, New South Wales, Australia, 2077
Status
Study Complete
Location
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44263
Status
Study Complete
Location
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
Status
Study Complete
Location
GSK Investigational Site
Collegeville, Pennsylvania, United States, 19426
Status
Study Complete
Location
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Status
Study Complete
Location
GSK Investigational Site
Hazard, Kentucky, United States, 41701
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1424BSF
Status
Study Complete
Location
GSK Investigational Site
Roseville, California, United States, 95661
Status
Study Complete
Location
GSK Investigational Site
Quilmes, Buenos Aires, Argentina, B1878FNR
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
River Forest, Illinois, United States, 60305
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Valrico, Florida, United States, 33596
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90505
Status
Study Complete
Location
GSK Investigational Site
Napa, California, United States, 94558
Status
Study Complete
Location
GSK Investigational Site
Blacktown, New South Wales, Australia, 2148
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46256
Status
Study Complete
Location
GSK Investigational Site
Aschaffenburg, Bayern, Germany, 63739
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Coeur D'Alene, Idaho, United States, 83814
Status
Study Complete
Location
GSK Investigational Site
Englewood, Colorado, United States, 80112
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Location
GSK Investigational Site
Stockton, California, United States, 95207
Status
Study Complete
Location
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56068
Status
Study Complete
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
Status
Study Complete
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37909
Status
Study Complete
Location
GSK Investigational Site
Mission Viejo, California, United States, 92691
Status
Study Complete
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
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
2011-15-09
Actual study completion date
2011-15-09
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.
Additional information about the trial
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