Status:
COMPLETED
Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics
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 and fluticasone furoate inhalation powder both administered once daily in ...
Eligibility Criteria
Inclusion
- Outpatients at least 12 years of age
- Male and female; female subjects of childbearing potential must be willing to use birth control
- Pre-bronchodilator FEV1 of 40-90% predicted normal
- Reversibility FEV1 of at least 12% and 200mL
- Current asthma therapy includes inhaled corticosteroid use for at least 12 weeks prior to first visit
Exclusion
- History of life-threatening asthma during last 10 years
- Respiratory infection or oral candidiasis
- Asthma exacerbation requiring oral corticosteroids or that required overnight hospitalisation requiring additional asthma treatment
- Uncontrolled disease or clinical abnormality
- Allergies to study drugs or the excipients
- Taking another investigational medication or prohibited medication
- Night shift workers
- Current smokers or subjects with a smoking history of at least 10 pack years
Key Trial Info
Start Date :
August 20 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2011
Estimated Enrollment :
612 Patients enrolled
Trial Details
Trial ID
NCT01165138
Start Date
August 20 2010
End Date
October 19 2011
Last Update
February 14 2018
Active Locations (70)
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1
GSK Investigational Site
Bell Gardens, California, United States, 90201
2
GSK Investigational Site
Huntington Beach, California, United States, 92647
3
GSK Investigational Site
Long Beach, California, United States, 90808
4
GSK Investigational Site
Los Angeles, California, United States, 90048