Study HZA106827: 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 and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.

Key facts

Study ID

NCT01165138

Run by

GlaxoSmithKline

People needed

612

Starts

2010-08-20

Expected to finish

2011-10-19

Last updated by the study team

2018-02-14

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

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 — Newport Beach, 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 — Miami, Florida, United States
• GSK Investigational Site — Normal, Illinois, United States
• GSK Investigational Site — River Forest, Illinois, United States
• GSK Investigational Site — Columbia, Maryland, United States
• GSK Investigational Site — Rolla, Missouri, 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 — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Lake Oswego, Oregon, United States
• GSK Investigational Site — Medford, Oregon, United States
• GSK Investigational Site — Portland, Oregon, United States
• GSK Investigational Site — Orangeburg, South Carolina, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Sugar Land, Texas, United States
• GSK Investigational Site — Murray, Utah, United States
• GSK Investigational Site — Mannheim, Baden-Wurttemberg, Germany
• GSK Investigational Site — Bell Gardens, California, United States

Full record on ClinicalTrials.gov

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