Status:
COMPLETED
Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate in People With Asthma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in ...
Detailed Description
This will be a multi-centre, randomised, placebo controlled (with rescue medication), double-blind, parallel group study. Subjects meeting all the inclusion criteria and none of the exclusion criteria...
Eligibility Criteria
Inclusion
- Signed informed consent
- Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks before 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 200mls
- Current asthma therapy that includes a non-corticosteroid controller and/or short-acting beta agonist
Exclusion
- History of life-threatening asthma exacerbation within the past 10 years
- Asthma exacerbation requiring treatment with oral corticosteroids within the last 3 months or that required overnight hospital stay within 6 months
- Current or recent respiratory infection or current oral candida infection
- Presence of another significant respiratory disease or medical condition that is not controlled or that could affect subject safety or study outcome
- Known or suspected allergy to study drug or materials
- Taking another investigational medication or prohibited medication during the study
- Previous treatment with inhaled fluticasone furoate in a phase II or III study
- Current smokers or former smokers with significant tobacco exposure
- Children in Care
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT01436071
Start Date
September 1 2011
End Date
August 1 2012
Last Update
January 11 2017
Active Locations (24)
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1
GSK Investigational Site
Long Beach, California, United States, 90808
2
GSK Investigational Site
Los Angeles, California, United States, 90025
3
GSK Investigational Site
Newport Beach, California, United States, 92663
4
GSK Investigational Site
Albany, Georgia, United States, 31707