Evaluating the Efficacy and Safety of Fluticasone Furoate in the Treatment of Asthma in Adults and Adolescents
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two
      doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and
      adolescents currently receiving mid to high strength inhaled corticosteroids.
    

Detailed description: 
      This will be a multi-centre, randomised, 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 four week Run-In period during which they will remain on their baseline
      ICS medication. In addition, all subjects will be provided with albuterol/salbutamol for
      relief of asthma symptoms. 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. Subjects will receive a contact (Phone Contact
      1/optional office visit (1b)) during Run-In to reinforce compliance with Run-In medication
      and diary monitoring. Those subjects who meet the eligibility criteria at the end of the
      Run-In period will be stratified in an approximately 1:1 ratio according to their baseline
      FEV1 as a percentage of predicted normal - one stratum for those with FEV1 percent predicted
      ≥40% to ≤65% and one for those with FEV1 percent predicted >65% to ≤90%. Once stratified,
      subjects will be randomised to one of the following treatments and enter into a 24 week
      double-blind treatment period:1) Fluticasone furoate 100mcg once daily in the evening or 2)
      Fluticasone furoate 200mcg once daily in the evening.

      Subjects will then attend 6 on-treatment visits at Visits 3, 4, 5, 6, 7 and 8 (Weeks 2, 4, 8,
      12, 18 and 24 respectively). All visits including Visit 1 must be conducted in the evening
      between 5 PM and 11 PM. Subjects will receive treatment for 24 weeks. Twenty four hour
      urinary cortisol assessments will be collected at the end of Run-In (Visit 2) and at end of
      treatment (Visit 8) visits. A follow-up contact will be performed 1-week after completing
      study medication (Visit 9). Subjects will participate in the study for up to a maximum of 29
      weeks (including screening, treatment and follow-up contact). In addition, partially used
      NDPIs will be collected in a subset of subjects. For subjects who have consented for
      pharmacogenetics, a blood sample will also be taken for pharmacogenetic analysis.
    

Intervention name(s): fluticasone furoate; albuterol/salbutamol
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled corticosteroid; Provided as rescue relief of asthma symptoms
Intervention MeSH terms: Fluticasone; Xhance; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fluticasone furoate