Last updated: 11/07/2018 04:22:29

Evaluating the efficacy and safety of Fluticasone Furoate Inhalation Powder in the treatment of asthma in adults and adolescentsn/a

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GSK study ID
112059
See study documents
Clinicaltrials.gov ID
NCT01159912
See results summary
EudraCT ID
2010-020100-34
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: A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.
Trial description: A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Mean change from Baseline in clinic visit trough evening (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

Secondary outcomes:

Change from Baseline in the percentage of rescue-free 24-hour (hr) periods at the end of the 24-week Treatment Period

Timeframe: Baseline and Week 24

Mean change from Baseline in daily trough evening (PM) Peak Expiratory Flow (PEF) averaged over the first 12 weeks and 24 weeks of the 24-week Treatment Period

Timeframe: From Baseline up to Week 12 and Week 24

Mean change from Baseline in daily morning (AM) PEF averaged over the first 12 weeks and 24 weeks of the 24-week Treatment Period

Timeframe: From Baseline up to Week 12 and Week 24

Change from Baseline in the percentage of symptom-free 24-hour (hr) 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

Timeframe: Baseline, Week 12, and Week 24

Interventions:
  • Drug: Fluticasone propionate
  • Drug: Fluticasone furoate
  • Drug: Placebo
    • Enrollment:
    350
    Primary completion date:
    2012-16-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Lötvall J, Bleecker ER, Busse WW, O’Byrne PM, Woodcock A, Kerwin EM, Stone S, Forth R, Jacques L, Bateman ED. Efficacy and safety of fluticasone furoate 100µg once-daily in patients with persistent asthma: a 24-week placebo and active-controlled randomised trial. Respir Med. 2014;108(1):41-9.
    Medical condition
    Asthma
    Product
    fluticasone furoate, fluticasone propionate
    Collaborators
    Not applicable
    Study date(s)
    June 2010 to January 2012
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Signed informed consent
    • Outpatient at least 12 years of age
    • History of life threatening asthma
    • Respiratory infection or candidiasis
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Signed informed consent
    • Outpatient at least 12 years of age
    • Both genders; females of child bearing potential must be willing to use approved 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 4 weeks prior to first visit
    Exclusion criteria:
    • History of life threatening asthma
    • Respiratory infection or candidiasis
    • Asthma exacerbation within 6 months prior to first visit
    • Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
    • Allergies to study drugs, study drug 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
    Franklin, Ohio, United States, 45005
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Shelby, North Carolina, United States, 28152
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92120
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbia, Missouri, United States, 65203
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73103
    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)
    Protocol
    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
    2012-16-01
    Actual study completion date
    2012-16-01

    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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