Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate in People With Asthma

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids

• 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 with diagnosis of asthma at least 12 weeks before first visit

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

• Pre-bronchodilator FEV1 of at least 60% predicted

• FEV1 reversibility of at least 12% and 200mls

• Current asthma therapy that includes a non-corticosteroid controller and/or short-acting beta agonist

Exclusion Criteria:

• History of life-threatening asthma exacerbation within the past 10 years

• Asthma exacerbation requiring treatment with oral corticosteroids within the last 3 months or that required overnight hospital stay within 6 months

• Current or recent respiratory infection or current oral candida infection

• Presence of another significant respiratory disease or medical condition that is not controlled or that could affect subject safety or study outcome

• Known or suspected allergy to study drug or materials

• Taking another investigational medication or prohibited medication during the study

• Previous treatment with inhaled fluticasone furoate in a phase II or III study

• Current smokers or former smokers with significant tobacco exposure

• Children in Care