Status:
COMPLETED
Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older wit...
Eligibility Criteria
Inclusion
- Outpatient at least 12 years of age
- Both genders; females of childbearing potential must be willing to use birth control method
- Clinical diagnosis of asthma for ≥12 weeks
- Best pre-bronchodilator FEV1 of 40%-90% predicted
- Reversibility of FEV1 of at least 12% and 200mls
- Current asthma therapy that include an inhaled corticosteroid for at least 12 weeks prior to 1st visit
- Ability to use replace current short-acting rescue treatment with albuterol and ability to withhold albuterol use for at least 6 hours prior to study visits
Exclusion
- History of life-threatening asthma
- Respiratory infection within last 4 weeks leading to change in asthma management
- Asthma exacerbation within last 3 months
- Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
- Allergies to study drugs, study drugs' excipients, or medications related to study drugs
- Taking another investigational medication or medication prohibited for use during the study.
- Previous participation in a vilanterol (GW642444) study
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2011
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT01181895
Start Date
September 1 2010
End Date
August 26 2011
Last Update
November 8 2017
Active Locations (34)
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1
GSK Investigational Site
Huntington Beach, California, United States, 92647
2
GSK Investigational Site
Orlando, Florida, United States, 32822
3
GSK Investigational Site
Tallahassee, Florida, United States, 32308
4
GSK Investigational Site
Lawrenceville, Georgia, United States, 30046