A Dose-ranging Study of Fluticasone Furoate (FF)
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone Furoate; Fluticasone Propionate; Placebo
Intervention description: current asthma medicine; Fluticasone propionate; placebo
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 597.0
Sex: All
Minimum age: 5 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This is a Phase IIb, multi-centre, stratified, randomised, double-blind, double-dummy,
      parallel-group, placebo and active controlled study in children aged 5-11 years with
      persistent uncontrolled asthma. Subjects meeting all of the inclusion criteria and none of
      the exclusion criteria at the screening visit (Visit 1) will enter a four week run-in period
      during which time they will continue their current medications. Visit 2 will occur two weeks
      into the run-in period to allow a review of compliance with daily diary and run-in
      medication. At Visit 3 (end of run-in/randomization visit), subjects meeting the eligibility
      criteria who remain uncontrolled despite baseline therapy will be stratified based on pre
      screening inhaled corticosteroid (ICS) use. Once stratified, subjects will be randomised to
      the treatment phase of the study where they will receive one of five treatments for 12 weeks.
      Approx 1200 subjects ages 5 to 11 will be screened to achieve 575 randomized for a total of
      115 randomized/evaluable subjects per treatment arm. Subjects will attend on-treatment visits
      at 2, 4, 8 and 12 weeks (Visits 4, 5, 6 and 7 respectively). A follow-up contact will be
      performed one week after completing study medication. All subjects must attempt spirometry
      measurements at Visits 1 and 3. For all subjects, a timed 24-hour urine collection for
      urinary cortisol and creatinine excretion will be performed prior to randomization at Visit 2
      and within 7 days prior to Visit 7. All subjects must perform PEF daily between visits 1 and
      7. The primary endpoint will be change from baseline in pre-dose (i.e. dosing trough) PM PEF
      from patient hand held electronic daily diary at Endpoint (Endpoint is defined as the mean
      over the last 7 days of treatment). Safety assessments include adverse events, oropharyngeal
      examinations, clinical chemistry, urinary cortisol, and vital signs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent from at least one parent/ legal guardian to take part in the
             study.:

          -  Diagnosis of asthma

          -  pre-bronchodilator PEF between ≥50% to ≤90% of their best post-bronchodilator value

          -  Receiving therapy of short acting beta-agonist (SABA) alone, LTM, or ICS (total daily
             dose <FP 200mcg or equivalent)Exclusion :

        Exclusion Criteria:

          -  history of life-threatening asthma

          -  history of asthma exacerbation for asthma within 6 months prior to screening.

          -  Culture-documented or suspected bacterial or viral infection

          -  significant abnormality or medical condition

          -  Present use of any tobacco products