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

This study has been withdrawn prior to enrollment.
(No participants enrolled.)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01435902
First received: September 15, 2011
Last updated: February 22, 2013
Last verified: February 2013

September 15, 2011
February 22, 2013
October 2011
October 2011   (final data collection date for primary outcome measure)
Maximal percent decrease from baseline in FEV1 following exercise challenge at 12 hours post-dose [ Time Frame: At the end of treatment Week 4 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01435902 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of a New Asthma Medicine in Asthmatics Whose Asthma Worsens With Exercise
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Activity/Exercise Induced Bronchospasm
  • Drug: Fluticasone Furoate/Vilanterol Inhalation Powder
    Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 4 weeks
  • Drug: Fluticasone Propionate Inhalation Powder
    Fluticasone propionate inhalation powder inhaled orally twice daily for 4 weeks
  • Active Comparator: Fluticasone Furoate/Vilanterol
    Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 4 weeks
    Intervention: Drug: Fluticasone Furoate/Vilanterol Inhalation Powder
  • Active Comparator: Fluticasone Propionate
    Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 4 weeks
    Intervention: Drug: Fluticasone Propionate Inhalation Powder
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2011
October 2011   (final data collection date for primary outcome measure)

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)
Both
12 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01435902
106847
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP