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