Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

• Status: Completed
• Trial end date: 2011-10-19
• Target enrollment: 0
• Participant gender: All

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 adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Xhance

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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