Status:
WITHDRAWN
A Study of a New Asthma Medicine in Asthmatics Whose Asthma Worsens With Exercise
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
12-50 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01435902
Start Date
January 1 2012
End Date
August 1 2012
Last Update
June 23 2014
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