Last updated: 11/07/2018 09:07:21

Clinical study evaluating safety and efficacy of fluticasone furoate and fluticasone propionate in people with asthmaN/A

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GSK study ID
115285
See study documents
Clinicaltrials.gov ID
NCT01436110
See results summary
EudraCT ID
2011-001900-36
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 multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids
Trial description: A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in clinic visit 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 over the 24-week treatment period

Timeframe: From Baseline up to Week 24

Change from Baseline in daily evening (PM) peak expiratory flow (PEF) averaged over the 24-week treatment period

Timeframe: From Baseline up to Week 24

Change from Baseline in daily morning (AM) PEF averaged over the 24-week treatment period

Timeframe: From Baseline up to Week 24

Change from Baseline in the percentage of symptom-free 24-hour (hr) periods during the 24-week treatment period

Timeframe: From Baseline up to Week 24

Number of participants who withdrew due to lack of efficacy during the 24-week treatment period

Timeframe: From the first dose of the study medication until Week 24/Early Withdrawal

Interventions:
  • Drug: Fluticasone furoate 50mcg
  • Drug: Fluticasone propionate 100mcg
  • Drug: Placebo
    • Enrollment:
    351
    Primary completion date:
    2012-26-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Busse W, Bateman E, O’Byrne P, Lötvall J, Woodcock A, Medley H, Forth R, Jacques L. Once-daily fluticasone furoate 50mcg in mild to moderate asthma: a 24-week placebo-controlled randomized trial. Allergy. 2014;69(11):1522-30.
    Medical condition
    Asthma
    Product
    fluticasone furoate, fluticasone propionate
    Collaborators
    Not applicable
    Study date(s)
    September 2011 to September 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 with a diagnosis of asthma at least 12 weeks prior to first visit
    • History of life-threatening asthma exacerbation with the past 10 years
    • Asthma exacerbation requiring oral corticosteroids within the past 3 months or overnight hospital stay within the past 6 months
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Signed informed consent
    • Outpatient at least 12 years of age with a diagnosis of asthma at least 12 weeks prior to first visit
    • Both genders; females of child bearing potential must be willing to use appropriate contraception during the study
    • Pre-bronchodilator FEV1 of at least 60% predicted
    • FEV1 reversibility of at least 12% and 200ml
    • Current asthma therapy that includes a non-corticosteroid controller and/or short acting beta-agonist
    Exclusion criteria:
    • History of life-threatening asthma exacerbation with the past 10 years
    • Asthma exacerbation requiring oral corticosteroids within the past 3 months or overnight hospital stay within the past 6 months
    • Current or recent respiratory infection or current oral candida infection
    • Presence of a significant respiratory disease or other medical condition that is uncontrolled or that could affect subject safety or study outcome
    • Known or suspected allergy to study medication or materials
    • Taking another investigational medication or prohibited medication during the study
    • Current smokers or former smokers with significant tobacco exposure
    • Previous treatment with fluticasone furoate in a phase II or III study
    • Children in Care

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    ZUTPHEN, Netherlands, 7207 AE
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Novosibirsk, Russia, 630087
    Status
    Study Complete
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    Location
    GSK Investigational Site
    EINDHOVEN, Netherlands, 5623 EJ
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Corsicana, Texas, United States, 75110
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lima 27, Lima, Peru, Lima 27
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Metairie, Louisiana, United States, 70006
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 42 Results

    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
    2012-26-09
    Actual study completion date
    2012-26-09

    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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