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
Completed
Completed
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:
Drug: Fluticasone furoate/Vilanterol Inhalation Powder
Drug: Fluticasone propionate/salmeterol Inhalation Powder
Drug: Placebo (1)
Drug: Placebo (2)
Enrollment:
810
Observational study model:
Not applicable
Primary completion date:
2011-27-07
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)
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1424BSF
Status
Study Complete
Location
GSK Investigational Site
Cheongju, Chungcheongbuk-do, South Korea, 361-711
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
Status
Study Complete
Location
GSK Investigational Site
Skillman, New Jersey, United States, 08558
Status
Study Complete
Location
GSK Investigational Site
Parana, Entre Ríos, Argentina, E3100BHK
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Wheaton, Maryland, United States, 20902
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90025
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80230
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
Status
Study Complete
Location
GSK Investigational Site
Quilmes, Buenos Aires, Argentina, B1878FNR
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucumán, Argentina, 4000
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000JKR
Status
Study Complete
Location
GSK Investigational Site
Rancagua, Reg Del Libert Bern Ohiggins, Chile, 2841959
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Centennial, Colorado, United States, 80112
Status
Study Complete
Location
GSK Investigational Site
Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
Status
Study Complete
Location
GSK Investigational Site
Valparaiso, Valparaíso, Chile, 2341131
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92117
Status
Study Complete
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20814
Status
Study Complete
Location
GSK Investigational Site
Cabanatuan City, Nueva Ecija, Philippines, 3100
Status
Study Complete
Location
GSK Investigational Site
Suwon, Kyonggi-do, South Korea, 443-721
Status
Study Complete
Location
GSK Investigational Site
Cherry Hill, New Jersey, United States, 08003
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
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
2011-27-07
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.
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