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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fluticasone Furoate/Vilanterol

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

Group Type ACTIVE_COMPARATOR

Fluticasone Furoate/Vilanterol Inhalation Powder

Intervention Type DRUG

Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 4 weeks

Fluticasone Propionate

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

Group Type ACTIVE_COMPARATOR

Fluticasone Propionate Inhalation Powder

Intervention Type DRUG

Fluticasone propionate inhalation powder inhaled orally twice daily for 4 weeks

Interventions

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Fluticasone Furoate/Vilanterol Inhalation Powder

Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 4 weeks

Intervention Type DRUG

Fluticasone Propionate Inhalation Powder

Fluticasone propionate inhalation powder inhaled orally twice daily for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

12 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No