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

Primary Purpose

Asthma

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Fluticasone Furoate/Vilanterol Inhalation Powder
Fluticasone Propionate Inhalation Powder
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring exercise-induced bronchospasm, Activity/Exercise induced bronchospasm, asthma

Eligibility Criteria

12 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Fluticasone Furoate/Vilanterol

    Fluticasone Propionate

    Arm Description

    Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 4 weeks

    Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 4 weeks

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Maximal percent decrease from baseline in FEV1 following exercise challenge at 1 hour and 23 hours post-dose
    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
    AUC (0-60 minutes) for percentage decrease from baseline in FEV1 after exercise at 1 hour, 12 hours, and 23 hours post-dose
    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%.
    Maximal percent decrease from pre-randomized treatment baseline in FEV1 following exercise challenge at 1 hour, 12 hours, and 23 hours post-dose.

    Full Information

    First Posted
    September 15, 2011
    Last Updated
    June 19, 2014
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01435902
    Brief Title
    A Study of a New Asthma Medicine in Asthmatics Whose Asthma Worsens With Exercise
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study was cancelled prior to enrolling any subjects
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    August 2012 (Anticipated)
    Study Completion Date
    August 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    exercise-induced bronchospasm, Activity/Exercise induced bronchospasm, asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fluticasone Furoate/Vilanterol
    Arm Type
    Active Comparator
    Arm Description
    Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 4 weeks
    Arm Title
    Fluticasone Propionate
    Arm Type
    Active Comparator
    Arm Description
    Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Fluticasone Furoate/Vilanterol Inhalation Powder
    Intervention Description
    Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Fluticasone Propionate Inhalation Powder
    Intervention Description
    Fluticasone propionate inhalation powder inhaled orally twice daily for 4 weeks
    Primary Outcome Measure Information:
    Title
    Maximal percent decrease from baseline in FEV1 following exercise challenge at 12 hours post-dose
    Time Frame
    At the end of treatment Week 4
    Secondary Outcome Measure Information:
    Title
    Maximal percent decrease from baseline in FEV1 following exercise challenge at 1 hour and 23 hours post-dose
    Time Frame
    At the end of treatment Week 4
    Title
    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
    Time Frame
    At the end of treatment Week 4
    Title
    AUC (0-60 minutes) for percentage decrease from baseline in FEV1 after exercise at 1 hour, 12 hours, and 23 hours post-dose
    Time Frame
    At the end of treatment Week 4
    Title
    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%.
    Time Frame
    At the end of treatment Week 4
    Title
    Maximal percent decrease from pre-randomized treatment baseline in FEV1 following exercise challenge at 1 hour, 12 hours, and 23 hours post-dose.
    Time Frame
    At the end of treatment Week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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