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

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

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

This will be a multi-centre, randomised, placebo controlled (with rescue medication), double-blind, parallel group study. Subjects meeting all the inclusion criteria and none of the exclusion criteria during Visit 1 (Screening Visit) will enter a two week Run-in Period. Subjects failing screening will not be eligible for re-screening. During the run-in and double-blind treatment periods subjects will maintain an electronic daily diary to record morning and evening peak expiratory flow (PEF), asthma symptom score and rescue albuterol/salbutamol use. At Visit 2 (end of run-in/Randomisation Visit), subjects meeting the eligibility criteria will be randomised to either inhaled Fluticasone Furoate 50 mcg or inhaled placebo. In addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms. Subjects will attend 4 on-treatment visits at Visits 3, 4, 5, and 6 (Weeks 2, 4, 8 and 12 respectively). Subjects will receive treatment for 84 days (12 weeks). A follow-up contact will be performed 1-week after completing study medication (Visit 7). Subjects will participate in the study for up to a maximum of 15 weeks (including screening, treatment and follow-up contact).

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