Last updated: 11/03/2018 09:14:46

A Study of a New Asthma Medicine in Asthmatics Whose Asthma Worsens with Exercise

GSK study ID
106847
Clinicaltrials.gov ID
NCT01435902
EudraCT ID
2011-004437-13
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Double-Dummy, Crossover Comparison of Fluticasone Furoate/Vilanterol 100/25 mcg Once Daily Versus Fluticasone Propionate 250 mcg Twice Daily in Asthmatic Adolescent and Adult Subjects with Exercise-Induced Bronchoconstriction
Trial description: The primary objective of this study is to demonstrate that the combination of inhaled fluticasone furoate/vilanterol (100 mcg/25 mcg) once daily provides superior protection throughout the day against bronchoconstriction induced by exercise compared with
fluticasone propionate 250 mcg twice daily in adolescent and adult subjects aged 12 to 50 diagnosed with persistent asthma.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Maximal percent decrease from baseline in FEV1 following exercise challenge at 12 hours post-dose

Timeframe: At the end of treatment Week 4

Secondary outcomes:

Maximal percent decrease from baseline in FEV1 following exercise challenge at 1 hour and 23 hours post-dose

Timeframe: At the end of treatment Week 4

Time required for recovery to within 5% of the pre-exercise baseline FEV1 from the time of the maximal percentage decrease from baseline following the challenge at 1 hour, 12 hours, and 23 hours post-dose

Timeframe: At the end of treatment Week 4

AUC (0-60 minutes) for percentage decrease from baseline in FEV1 after exercise at 1 hour, 12 hours, and 23 hours post-dose

Timeframe: At the end of treatment Week 4

Evaluation of a categorical treatment response using the percentage of subjects who demonstrate a decrease from the pre-exercise baseline in FEV1 of 1) <10%, 2) 10 to <20%, and 3) =/>20%.

Timeframe: At the end of treatment Week 4

Maximal percent decrease from pre-randomized treatment baseline in FEV1 following exercise challenge at 1 hour, 12 hours, and 23 hours post-dose.

Timeframe: At the end of treatment Week 4

Interventions:
  • Drug: Fluticasone Furoate/Vilanterol Inhalation Powder
  • Drug: Fluticasone Propionate Inhalation Powder
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    January 2012 to October 2012
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 50 years
    Accepts healthy volunteers
    No
    • Outpatient male or female 12 to 50 years of age
    • Females of child-bearing potential must be willing to use birth control or commit to abstinence during the study
    • Intermittent asthma, seasonal asthma, or exercise-induced asthma only
    • Symptomatic allergic rhinitis and/or thrush
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Outpatient male or female 12 to 50 years of age
    • Females of child-bearing potential must be willing to use birth control or commit to abstinence during the study
    • Diagnosis of persistent asthma for at least 6 months
    • Best pre-bronchodilator FEV1 of at least 70%.
    • Current use of a low- to moderate-dose inhaled corticosteroid
    • Ability to withhold albuterol 6 hours prior to visits.
    • Physically able to perform exercise testing on a treadmill when albuterol has been withheld
    Exclusion criteria:
    • Intermittent asthma, seasonal asthma, or exercise-induced asthma only
    • Symptomatic allergic rhinitis and/or thrush
    • Abnormal, clinically significant electrocardigraph
    • Respiratory infection within 4 weeks of first visit leading to asthma medication change or could affect subjects's asthma status or participation
    • Asthma exacerbation within 12 weeks of first visit
    • Respiratory diseases or other concurrent disease that would put subject at risk or confound results interpretation
    • Investigational medicines within 30 days of first visit or less than five half-lives of medication in prior study
    • Allergy to study drugs or study drug excipients
    • Concomitant medications that could interact with study medications or affect the course of asthma
    • Tobacco use within last year and/or a 10 pack-years history
    • Inability to comply with requirements of the study
    • Affiliation with investigator's site (example: family member)

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    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

    Additional information
    Not applicable
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