Status:
COMPLETED
Evaluating the Efficacy and Safety of Fluticasone Furoate in the Treatment of Asthma in Adults and Adolescents
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
12-100 years
Phase:
PHASE3
Brief Summary
A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently...
Detailed Description
This will be a multi-centre, randomised, double-blind, parallel-group study. Subjects meeting all the inclusion criteria and none of the exclusion criteria during Visit 1 (screening visit) will enter ...
Eligibility Criteria
Inclusion
- Signed informed consent
- Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks prior to first visit
- Both genders; females of child bearing potential must be willing to use appropriate contraception
- Pre-bronchodilator FEV1 of 40-90% predicted
- Reversibility FEV1 of at least 12% and 200mLs
- Current asthma therapy that includes inhaled corticosteroid for at least 4 weeks prior to first visit
Exclusion
- History of life threatening asthma
- Respiratory infection or candidiasis
- Asthma exacerbation requiring OCS within last 4 weeks or overnight hospital stay within the last 3 months
- Concurrent respiratory disease or other disease that would confound study participation of 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 the study
- Previous treatment with FF or FF/VI in a phase II or III study
- Night shift workers
- Children in care
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT01431950
Start Date
September 1 2011
End Date
October 1 2012
Last Update
January 9 2017
Active Locations (40)
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1
GSK Investigational Site
Long Beach, California, United States, 90808
2
GSK Investigational Site
Newport Beach, California, United States, 92663
3
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
4
GSK Investigational Site
Clearwater, Florida, United States, 33756