Crossover Study Comparing Fluticasone Furoate (FF)/Vilanterol (VI) Once Daily Versus Fluticasone Propionate (FP) Twice Daily in Subjects With Asthma and Exercise-Induced Bronchoconstriction (EIB)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicenter, randomized, double-blind, double-dummy, crossover study with two
      2-week treatment periods separated by a 2-week wash-out period. Subjects will participate in
      up to eight study visits and have a follow up phone call approximately a week after the last
      clinic visit. Visits 1, 2, 3, 5 and 6 are evening visits that will be conducted between 5PM
      and 11PM. Visit 4 and Visit 7 are also evening visits that will begin between 5PM and 11PM
      and continue over a period of approximately 24 hours. Subjects will be required to attend
      three clinic visits during this 24-hour period. An exercise challenge (using a treadmill)
      will be conducted at Visit 2, Visit 3 and Visit 6 (after 23 hours of the first treatment dose
      in each Treatment Period); and at 12 and 23 hours post evening dose at Visits 4 and 7.
      Spirometry will be conducted at specified visits and prior to and after each exercise
      challenge.

      Subjects with symptomatic allergic rhinitis at Visit 1 (screening) may be treated for up to
      four weeks with intranasal corticosteroids followed by a repeat screening visit to determine
      eligibility prior to entry into the study.

      Eligible subjects at visit 1 will complete a 4-week single blind run-in on FP 250 microgram
      (mcg) twice daily (BID), followed by 2-week double-blind Treatment Period 1 on randomized
      treatment, a 2-week single blind washout period on FP 250 mcg BID, 2-week double-blind
      Treatment Period 2 receiving the alternative treatment, and follow-up contact approximately
      7-days after completing Treatment Period 2. The total duration of study participation is
      approximately 11 weeks; and up to 15 weeks for subjects with Symptomatic Allergic Rhinitis.

      The primary objective of the study is to evaluate the protective effect of fluticasone
      furoate/vilanterol (FF/VI) 100/25 mcg once-daily compared with fluticasone propionate (FP)
      250 mcg twice-daily against exercise-induced bronchoconstriction in adolescent and adult
      subjects aged 12 to 50 with persistent asthma.

      ELLIPTA, ACCUHALER, and DISKUS are registered trademarks of the GlaxoSmithKline group of
      companies.
    


Intervention name(s): Fluticasone furoate/ Vilanterol 100 mcg/25 mcg; Fluticasone propionate 250 mcg; Placebo via ELLIPTA inhaler; Placebo via DISKUS / ACCUHALER
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): FF/VI 100/25 mcg will be administered via ELLIPTA inhaler once daily in the evening; FP 250mcg will be administered via DISKUS inhaler, twice daily, once in the morning and once in the evening; Placebo will be administered via ELLIPTA inhaler once daily in the evening; Placebo will be administered via DISKUS / ACCUHALER, twice daily, once in the morning and once in the evening
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fluticasone furoate; activity monitoring; Vilanterol; Cross-over; exercise-induced bronchoconstriction; exercise challenge; double-dummy; asthma; spirometry; fluticasone propionate