Last updated: 11/07/2018 05:38:12
HZA113091 Efficacy and safety of Fluticasone furoate/Vilanterol (GW642444) in Adults and Adolescents
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomised, double-blind, double-dummy, parallel-group multicentre study to assess efficacy and safety of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Propionate/Salmeterol Inhalation Powder 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 with fluticasone propionate/salmeterol administered twice daily 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 weighted-mean 24 hour serial FEV1 on Day 168/Week 24
Timeframe: Baseline and Day 168/Week 24
Secondary outcomes:
Serial FEV1 (0-24 hours)
Timeframe: Day 168
Number of participants with the indicated time to onset of bronchodilator effect at Day 1
Timeframe: Baseline to Day 1
Change from Baseline in weighted mean serial FEV1 over 0-4 hours post first dose (at Randomization)
Timeframe: Baseline and Randomization
Change from Baseline in weighted mean serial FEV1 over 0-4 hours at Day 168
Timeframe: Baseline and Day 168
Number of participants obtaining a >=12% and >=200 mL increase from Baseline in FEV1
Timeframe: Baseline and Day 168
Change from Baseline in Trough FEV1 at Day 168
Timeframe: Baseline and Day 168
Interventions:
Enrollment:
810
Primary completion date:
2011-27-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Woodcock A, Bleecker ER, Lötvall J, O’Byrne PM, Bateman ED, Medley H, Ellsworth A, Jacques L, Busse WW. Efficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthma: a randomized trial. Chest. 2013;144(4):1222-1229.
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, vilanterol
Collaborators
Not applicable
Study date(s)
June 2010 to July 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Clinical diagnosis of asthma
- Reversibility of at least 12% and at least 200mLs within 10-40 minutes following 2-4 inhalations of albuterol
- History of life-threatening asthma within previous 5 years (requiring intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures)
- Respiratory infection or oral candidiasis
Inclusion and exclusion criteria
Inclusion criteria:
- Clinical diagnosis of asthma
- Reversibility of at least 12% and at least 200mLs within 10-40 minutes following 2-4 inhalations of albuterol
- FEV1 of 40-85% predicted normal
- Currently using inhaled corticosteroid therapy
Exclusion criteria:
- History of life-threatening asthma within previous 5 years (requiring intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures)
- Respiratory infection or oral candidiasis
- Asthma exacerbation requiring oral corticosteroids or that resulted in overnight hospitalisation requiring additional asthma treatment
- Uncontrolled disease or clinical abnormality
- Allergies
- Taking another investigational medication or prohibited medication
- Night shift workers
- Current smokers or subjects with smoking history of at least 10 pack years
Trial location(s)
Showing 1 - 6 of 58 Results
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
Study complete
Actual primary completion date
2011-27-07
Actual study completion date
2011-27-07
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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