Status:
COMPLETED
Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment o...
Detailed Description
This is a multi-center, randomized, double-blind, double-dummy, parallel-group study to compare the efficacy and safety of Fluticasone Furoate Inhalation Powder 100mcg once daily and Fluticasone Propi...
Eligibility Criteria
Inclusion
- Signed informed consent
- Outpatient at least 12 years of age
- Both genders; females of child bearing potential must be willing to use approved birth control method
- Pre-bronchodilator FEV1 of 40-90% predicted
- Reversibility FEV1 of at least 12% and 200mLs
- Current asthma therapy that includes an inhaled corticosteroid for at least 4 weeks prior to first visit
Exclusion
- History of life threatening asthma
- Respiratory infection or candidiasis
- Asthma exacerbation within 6 months prior to first visit
- Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
- Allergies to study drugs, study drug excipients, medications related to study drugs
- Taking another investigational medication or medication prohibited for use during this study
Key Trial Info
Start Date :
June 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2012
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT01159912
Start Date
June 30 2010
End Date
January 16 2012
Last Update
November 9 2017
Active Locations (82)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35209
2
GSK Investigational Site
Montgomery, Alabama, United States, 36106
3
GSK Investigational Site
Green Valley, Arizona, United States, 85614
4
GSK Investigational Site
Little Rock, Arkansas, United States, 72205