HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents

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 with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.

Key facts

Study ID

NCT01147848

Run by

GlaxoSmithKline

People needed

810

Starts

2010-06-01

Expected to finish

2011-07-01

Last updated by the study team

2017-01-18

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Riverside, California, United States
• GSK Investigational Site — Rolling Hills Estates, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Centennial, Colorado, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Cocoa, Florida, United States
• GSK Investigational Site — Bethesda, Maryland, United States
• GSK Investigational Site — Wheaton, Maryland, United States
• GSK Investigational Site — Rolla, Missouri, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Cherry Hill, New Jersey, United States
• GSK Investigational Site — Skillman, New Jersey, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Medford, Oregon, United States
• GSK Investigational Site — Greenville, South Carolina, United States
• GSK Investigational Site — Orangeburg, South Carolina, United States
• GSK Investigational Site — Spartanburg, South Carolina, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Waco, Texas, United States
• GSK Investigational Site — Huntington Beach, California, United States

Full record on ClinicalTrials.gov

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