Clinical trial NCT01435902: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Asthma
Keywords: exercise-induced bronchospasm
Activity/Exercise induced bronchospasm
asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: 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:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: