Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents

• Status: Completed
• Trial end date: 2012-01-16
• Target enrollment: 0
• Participant gender: All

Summary

A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Xhance

Criteria

Inclusion Criteria:

• Signed informed consent

• Outpatient at least 12 years of age

• Both genders; females of child bearing potential must be willing to use approved 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 4 weeks prior to first visit

Exclusion Criteria:

• History of life threatening asthma

• Respiratory infection or candidiasis

• Asthma exacerbation within 6 months prior to first visit

• Concurrent respiratory disease or other disease that would confound study participation or affect subject safety

• Allergies to study drugs, study drug excipients, medications related to study drugs

• Taking another investigational medication or medication prohibited for use during this study