Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily each evening with fluticasone furoate inhalation powder administered alone once daily each evening in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.

Key facts

Study ID

NCT01134042

Run by

GlaxoSmithKline

People needed

587

Starts

2010-06-01

Expected to finish

2011-10-01

Last updated by the study team

2017-01-11

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Outpatient at least 12 years of age
• Both genders; females of childbearing potential must be willing to use birth control method
• Pre-bronchodilator FEV1 of 40-90% predicted
• Reversibility FEV1 of at least 12% and 200mls
• Current asthma therapy that includes an inhaled corticosteroid for at least 12 weeks prior to first visit

You may not qualify if…

• History of life-threatening asthma
• Respiratory infection or oral candidiasis
• Asthma exacerbation within 12 weeks
• Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
• Allergies to study drugs, study drugs' excipients, medications related to study drugs
• Taking another investigational medication or medication prohibited for use during this study

Where it is running

• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Riverside, California, United States
• GSK Investigational Site — Roseville, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Clearwater, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Panama City, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Normal, Illinois, United States
• GSK Investigational Site — River Forest, Illinois, United States
• GSK Investigational Site — Asheville, North Carolina, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Lake Oswego, Oregon, United States
• GSK Investigational Site — Medford, Oregon, United States
• GSK Investigational Site — Orangeburg, South Carolina, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — El Paso, Texas, United States
• GSK Investigational Site — Sugar Land, Texas, United States
• GSK Investigational Site — Cottbus, Brandenburg, Germany
• GSK Investigational Site — Schwedt, Brandenburg, Germany
• GSK Investigational Site — Bell Gardens, California, United States

Full record on ClinicalTrials.gov

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