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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength inhaled corticosteroids.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Albuterol; Fluticasone; Xhance

Criteria

Inclusion Criteria:

• Signed informed consent

• Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks prior to first visit

• Both genders; females of child bearing potential must be willing to use appropriate contraception

• Pre-bronchodilator FEV1 of 40-90% predicted

• Reversibility FEV1 of at least 12% and 200mLs

• Current asthma therapy that includes inhaled corticosteroid for at least 4 weeks prior to first visit

Exclusion Criteria:

• History of life threatening asthma

• Respiratory infection or candidiasis

• Asthma exacerbation requiring OCS within last 4 weeks or overnight hospital stay within the last 3 months

• Concurrent respiratory disease or other disease that would confound study participation of 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 the study

• Previous treatment with FF or FF/VI in a phase II or III study

• Night shift workers

• Children in care