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

• Change from baseline in trough (pre-bronchodilator and pre-dose) FEV1 [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  Change from baseline in clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 12 week treatment period. Clinic FEV1 will be measured at screening and at all on-treatment clinic visits.
  
  

• Change from baseline in the percentage of rescue-free 24 hour periods [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  Change from baseline in the percentage of rescue-free 24 hour periods during the 12 week treatment period.
  
  
• Change from baseline in daily PM PEF (pre-bronchodilator) [ Time Frame: Averaged over the 12 week treatment period ] [ Designated as safety issue: No ]
  
• Change from baseline in daily AM PEF (pre-bronchodilator) [ Time Frame: Averaged over the 12 week treatment period ] [ Designated as safety issue: No ]
  
• Change from baseline in percentage of symptom free 24hr periods [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  Change from baseline symptom-free 24 hour periods during the 12 week treatment period
  
  
• Number of of withdrawals due to lack of efficacy [ Time Frame: Occuring at any time during the 12 week treatment period ] [ Designated as safety issue: No ]
  

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).