Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

• Change in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 in all subjects [ Time Frame: At the end of the 12-week treatment period ] [ Designated as safety issue: No ]
• Weighted mean serial FEV1 over 0-24 hours post-dose calculated in a subset of subjects performing serial FEV1 [ Time Frame: At the end of the 12-week treatment period ] [ Designated as safety issue: No ]

• Change in the percentage of rescue-free 24-hour periods [ Time Frame: Over the 12-week treatment period ] [ Designated as safety issue: No ]
• Change in the percentage of symptom-free 24-hour periods [ Time Frame: Over the 12-week treatment period ] [ Designated as safety issue: No ]
• Change in total AQLQ (+12) score [ Time Frame: At the end of the 12-week treatment period ] [ Designated as safety issue: No ]
• Number of withdrawals due to lack of efficacy [ Time Frame: Over the 12-week treatment period ] [ Designated as safety issue: No ]
• Clinic Visit, 12-hour FEV1 in the subset of subjects performing serial FEV1 assesments [ Time Frame: At the end of the 12-week treatment period ] [ Designated as safety issue: No ]
• Weighted mean serial FEV1over 0-24 hours post dose in the subset of subjects performing serial FEV1 assessment [ Time Frame: Over the first day of treatment ] [ Designated as safety issue: No ]
• Weighted mean serial FEV1over 0-4 hours post dose in the subset of subjects performing serial FEV1 assessment [ Time Frame: During the first day of treatment and at the end of the 12-week treatment period ] [ Designated as safety issue: No ]
• Time to onset of bronchodilator effect (the timepoint when FEV1 first exceeded 12.0% and 200mL increase over baseline) in the subset of subjects performing serial FEV1 assessments [ Time Frame: Over the first day of treatment ] [ Designated as safety issue: No ]
• Mean change in daily AM PEF [ Time Frame: Over the 12-week treatment period ] [ Designated as safety issue: No ]
• Mean change in daily PM PEF [ Time Frame: Over the 12-week treatment period ] [ Designated as safety issue: No ]
• Change in Asthma control Test (ACT) [ Time Frame: At the end of the 12-week treatment period ] [ Designated as safety issue: No ]
• Global assessment of change (assess asthma symptom change (improve, same, worse) and rescue use (more, same, less) [ Time Frame: At the end of 4 weeks, 8 weeks and the 12-week treatment period ] [ Designated as safety issue: No ]
• Unscheduled Healthcasre Resource Utilisation for Asthma [ Time Frame: Over the 12-week treatment period ] [ Designated as safety issue: No ]
• Inhaler use assessment [ Time Frame: At teh end of 2 weeks and 4 weeks of treatment ] [ Designated as safety issue: No ]
• Ease of use assessment on the inhaler [ Time Frame: At the end of 4 weeks of treatment ] [ Designated as safety issue: No ]

The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.

• Drug: Fluticasone furoate/Vilanterol Inhalation Powder
  Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 12 weeks
• Drug: Fluticasone Furoate Inhalation Powder
  Fluticasone Furoate Inhalation Powder inhaled orally once daily for 12 weeks
• Drug: Placebo Inhaltion Powder
  Placebo Inhaltion Powder inhaled orally once daily for 12 weeks

• Experimental: Fluticasone furoate/Vilanterol (GW642444)
  Fluticasone furoate/Vilanterol inhalation powder once daily for 12 weeks
  Intervention: Drug: Fluticasone furoate/Vilanterol Inhalation Powder
• Experimental: Fluticasone Furoate
  Fluticasone furoate inhalation powder once daily for 12 weeks
  Intervention: Drug: Fluticasone Furoate Inhalation Powder
• Placebo Comparator: Placebo
  Placebo inhalation powder once daily for 12 weeks
  Intervention: Drug: Placebo Inhaltion Powder

Inclusion Criteria:

• Outpatients at least 12 years of age
• Male and female; female subjects of childbearing potential must be willing to use birth control
• Pre-bronchodilator FEV1 of 40-90% predicted normal
• Reversibility FEV1 of at least 12% and 200mL
• Current asthma therapy includes inhaled corticosteroid use for at least 12 weeks prior to first visit

Exclusion Criteria:

• History of life-threatening asthma during last 10 years
• Respiratory infection or oral candidiasis
• Asthma exacerbation requiring oral corticosteroids or that required overnight hospitalisation requiring additional asthma treatment
• Uncontrolled disease or clinical abnormality
• Allergies to study drugs or the excipients
• Taking another investigational medication or prohibited medication
• Night shift workers
• Current smokers or subjects with a smoking history of at least 10 pack years