Last updated: 11/07/2018 01:40:11

Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

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GSK study ID
106829
See study documents
Clinicaltrials.gov ID
NCT01134042
See results summary
EudraCT ID
2010-019594-14
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2011-18-10
    Observational study model:
    Not applicable
    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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Fukuoka, Japan, 811-1394
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30342
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ishikawa, Japan, 920-8530
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Normal, Illinois, United States, 61761
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Asheville, North Carolina, United States, 28801
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hannover, Niedersachsen, Germany, 30167
    Status
    Study Complete
    Contact us
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    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
    2011-18-10
    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.

    Additional information about the trial

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