Last updated: 11/07/2018 01:40:11
Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: HZA106829: A randomised, double-blind, parallel group, multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder, Fluticasone Furoate Inhalation Powder alone, and Fluticasone Propionate alone in the treatment of persistent asthma in adults and adolescents
Trial description: The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily each evening with fluticasone furoate inhalation powder administered alone once daily each evening in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in clinic visit trough (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
Change from Baseline in weighted mean serial FEV1 over 0-24 hours post-dose at Week 24
Timeframe: Baseline and Week 24
Secondary outcomes:
Change from Baseline in the percentage of rescue-free and symptom-free 24-hour 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/Early Withdrawal
Timeframe: Baseline, Week 12, and Week 24/Early Withdrawal
Interventions:
Drug: Fluticasone Furoate/Vilanterol Inhalation Powder
Drug: Fluticasone Furoate Inhalation Powder
Drug: Fluticasone Propionate Inhalation Powder
Other: Placebo Inhalation Powder 1
Other: Placebo Inhalation Powder 2
Enrollment:
587
Observational study model:
Not applicable
Primary completion date:
2011-18-10
Time perspective:
Not applicable
Clinical publications:
O'Byrne PM, Bleecker ER, Bateman ED, Busse WW, Woodcock A, Forth R, Toler WT, Jacques L, Lötvall J. Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma. Eur Respir J. 2014;43(3):773-82.
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, vilanterol
Collaborators
Not applicable
Study date(s)
June 2010 to October 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Outpatient at least 12 years of age
- Both genders; females of childbearing potential must be willing to use birth control method
- History of life-threatening asthma
- Respiratory infection or oral candidiasis
Inclusion and exclusion criteria
Inclusion criteria:
- Outpatient at least 12 years of age
- Both genders; females of childbearing potential must be willing to use 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 12 weeks prior to first visit
Exclusion criteria:
- History of life-threatening asthma
- Respiratory infection or oral candidiasis
- Asthma exacerbation within 12 weeks
- Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
- Allergies to study drugs, study drugs' 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
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Normal, Illinois, United States, 61761
Status
Study Complete
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30167
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
River Forest, Illinois, United States, 60305
Status
Study Complete
Location
GSK Investigational Site
Lake Oswego, Oregon, United States, 97035
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23552
Status
Study Complete
Location
GSK Investigational Site
Roseville, California, United States, 95661
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90808
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33756
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
Status
Study Complete
Location
GSK Investigational Site
Sugar Land, Texas, United States, 77479
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Panama City, Florida, United States, 32405
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92128
Status
Study Complete
Location
GSK Investigational Site
Bell Gardens, California, United States, 90201
Status
Study Complete
Location
GSK Investigational Site
Cottbus, Brandenburg, Germany, 03050
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
2011-18-10
Actual study completion date
2011-18-10
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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