Status:
COMPLETED
HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administere...
Eligibility Criteria
Inclusion
- Clinical diagnosis of asthma
- Reversibility of at least 12% and at least 200mLs within 10-40 minutes following 2-4 inhalations of albuterol
- FEV1 of 40-85% predicted normal
- Currently using inhaled corticosteroid therapy
Exclusion
- History of life-threatening asthma within previous 5 years (requiring intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures)
- Respiratory infection or oral candidiasis
- Asthma exacerbation requiring oral corticosteroids or that resulted in overnight hospitalisation requiring additional asthma treatment
- Uncontrolled disease or clinical abnormality
- Allergies
- Taking another investigational medication or prohibited medication
- Night shift workers
- Current smokers or subjects with smoking history of at least 10 pack years
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
810 Patients enrolled
Trial Details
Trial ID
NCT01147848
Start Date
June 1 2010
End Date
July 1 2011
Last Update
January 18 2017
Active Locations (63)
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1
GSK Investigational Site
Huntington Beach, California, United States, 92647
2
GSK Investigational Site
Los Angeles, California, United States, 90025
3
GSK Investigational Site
Los Angeles, California, United States, 90048
4
GSK Investigational Site
Riverside, California, United States, 92506