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

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