Status:
COMPLETED
Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate and Fluticasone Propionate in People With Asthma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powde...
Detailed Description
This will be a multi-centre, randomised, placebo and active controlled (with rescue medication), double-blind, double-dummy, parallel-group study. Subjects meeting all the inclusion criteria and none ...
Eligibility Criteria
Inclusion
- Signed informed consent
- Outpatient at least 12 years of age with a 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 during the study
- Pre-bronchodilator FEV1 of at least 60% predicted
- FEV1 reversibility of at least 12% and 200ml
- Current asthma therapy that includes a non-corticosteroid controller and/or short acting beta-agonist
Exclusion
- History of life-threatening asthma exacerbation with the past 10 years
- Asthma exacerbation requiring oral corticosteroids within the past 3 months or overnight hospital stay within the past 6 months
- Current or recent respiratory infection or current oral candida infection
- Presence of a significant respiratory disease or other medical condition that is uncontrolled or that could affect subject safety or study outcome
- Known or suspected allergy to study medication or materials
- Taking another investigational medication or prohibited medication during the study
- Current smokers or former smokers with significant tobacco exposure
- Previous treatment with fluticasone furoate in a phase II or III study
- Children in Care
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
351 Patients enrolled
Trial Details
Trial ID
NCT01436110
Start Date
September 1 2011
End Date
September 1 2012
Last Update
January 9 2017
Active Locations (42)
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1
GSK Investigational Site
Los Angeles, California, United States, 90025
2
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
3
GSK Investigational Site
Sacramento, California, United States, 95819
4
GSK Investigational Site
San Jose, California, United States, 95117