Last updated: 11/07/2018 01:39:14
Study HZA106827: 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: HZA106827: A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder 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 and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from Baseline in clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in weighted mean serial FEV1 over 0-24 hours post-dose at Week 12
Timeframe: Baseline and Week 12
Secondary outcomes:
Mean change from Baseline in the percentage of rescue-free 24-hour (hr) periods during the 12-week Treatment Period
Timeframe: Baseline and Week 12
Change from Baseline in the percentage of symptom-free 24-hour (hr) periods during the 12-week Treatment Period
Timeframe: Baseline and Week 12
Change from Baseline in the total Asthma Quality of Life Questionnaire (AQLQ) (+12) score at Week 12/Early Withdrawal
Timeframe: Baseline and Week 12/Early Withdrawal
Number of participants who withdrew due to lack of efficacy during the 12-week treatment period
Timeframe: From the first dose of the study medication up to Week 12/Early Withdrawal
Serial FEV1 over 0-1 hour post-dose at Randomization
Timeframe: Randomization
Interventions:
Drug: Fluticasone furoate/Vilanterol Inhalation Powder
Drug: Fluticasone Furoate Inhalation Powder
Drug: Placebo Inhaltion Powder
Enrollment:
612
Observational study model:
Not applicable
Primary completion date:
2011-19-10
Time perspective:
Not applicable
Clinical publications:
Bleecker ER, Lötvall J, O’Byrne PM, Woodcock A, Busse WW, Kerwin EM, Forth R, Medley HV, Nunn C, Jacques L, Bateman ED. Fluticasone furoate-vilanterol 100-25mcg compared with fluticasone furoate 100 mcg in asthma: a randomized trial. J Allergy Clin Immunol In Pract. 2014;2(5):553-61.
Svedsater H, Jacques L, Goldfrad C, Bleecker ER. Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma. npj Primary Care Respiratory Medicine. 2014;24:14019.
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, vilanterol
Collaborators
Not applicable
Study date(s)
August 2010 to October 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Outpatients at least 12 years of age
- Male and female; female subjects of childbearing potential must be willing to use birth control
- History of life-threatening asthma during last 10 years
- Respiratory infection or oral candidiasis
Inclusion and exclusion criteria
Inclusion criteria:
- Outpatients at least 12 years of age
- Male and female; female subjects of childbearing potential must be willing to use birth control
- Pre-bronchodilator FEV1 of 40-90% predicted normal
- Reversibility FEV1 of at least 12% and 200mL
- Current asthma therapy includes inhaled corticosteroid use for at least 12 weeks prior to first visit
Exclusion criteria:
- History of life-threatening asthma during last 10 years
- Respiratory infection or oral candidiasis
- Asthma exacerbation requiring oral corticosteroids or that required overnight hospitalisation requiring additional asthma treatment
- Uncontrolled disease or clinical abnormality
- Allergies to study drugs or the excipients
- Taking another investigational medication or prohibited medication
- Night shift workers
- Current smokers or subjects with a smoking history of at least 10 pack years
Trial location(s)
Location
GSK Investigational Site
Newport Beach, California, United States, 92663
Status
Study Complete
Location
GSK Investigational Site
Lake Oswego, Oregon, United States, 97035
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90808
Status
Study Complete
Location
GSK Investigational Site
Normal, Illinois, United States, 61761
Status
Study Complete
Location
GSK Investigational Site
Frankfurt am Main, Hessen, Germany, 60596
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97213
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Columbia, Maryland, United States, 21044
Status
Study Complete
Location
GSK Investigational Site
Roseville, California, United States, 95661
Status
Study Complete
Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Status
Study Complete
Location
GSK Investigational Site
Sugar Land, Texas, United States, 77479
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
Status
Study Complete
Location
GSK Investigational Site
Austin, Texas, United States, 78756
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Oranienburg, Brandenburg, Germany, 16515
Status
Study Complete
Location
GSK Investigational Site
River Forest, Illinois, United States, 60305
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Bell Gardens, California, United States, 90201
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
2011-19-10
Actual study completion date
2011-19-10
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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