Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone 44 mcg; Fluticasone 220 mcg
Intervention description: Fluticasone is an inhaled corticosteroid; Fluticasone is an inhaled corticosteroid
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 254.0
Sex: All
Minimum age: 5 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Asthma; Fluticasone

Summary:

      The objective of this study is to determine whether, in children receiving low-dose inhaled
      corticosteroids (ICS), quintupling the dose of inhaled corticosteroids at the onset of
      symptoms previously associated with upper respiratory illnesses and subsequent asthma
      exacerbations reduces the rate of severe asthma exacerbations treated with oral
      corticosteroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physician-diagnosed asthma

          -  At least 1 exacerbation treated with systemic (oral or injectable) corticosteroids in
             the past 12 months

          -  Able to perform reproducible spirometry

          -  Current treatment with step 2 controller therapy [low-dose ICS, leukotriene receptor
             antagonist (LTRA)] OR current treatment with step 3 controller therapy [low-dose ICS +
             long-acting beta agonist (LABA), low-dose ICS + LTRA, or medium dose ICS] with a
             childhood Asthma Control Test (c-ACT) score of >19, no more than 2 prednisone treated
             exacerbations in the past 6 months, prebronchodilator Forced Expiratory Volume at 1
             second (FEV1) ≥ 80% predicted and willing to step down therapy OR controller naïve and
             qualifying for step 2 controller therapy [asthma symptoms or short acting beta agonist
             (SABA) use > 2 days per week or night-time awakenings due to asthma > 2 nights per
             month]

          -  Prebronchodilator FEV1 ≥ 60% predicted

          -  Ability and willingness to provide informed assent

          -  For females of childbearing potential: not pregnant, non-lactating, and agree to
             practice an adequate birth control method.

          -  History of clinical varicella or varicella vaccine

        Exclusion Criteria:

          -  Systemic (oral or injectable) corticosteroids within previous 2-week period

          -  Current or recent (previous 2-weeks) use of medications known to significantly
             interact with corticosteroid disposition, including but not limited to carbamazepine,
             erythromycin, phenobarbital, phenytoin, rifampin, and ketoconazole

          -  Presence of chronic or active lung disease other than asthma

          -  Significant medical illness other than asthma, including thyroid disease, diabetes
             mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical
             problems that could require oral corticosteroids during the study

          -  A history of cataracts, glaucoma, or any other medical disorder associated with an
             adverse effect to corticosteroids

          -  History of a life-threatening asthma exacerbation requiring intubation, mechanical
             ventilation, or resulting in a hypoxic seizure

          -  More than 5 prednisone treated exacerbations in the past 12 months

          -  More than 1 hospitalizations lasting >24 hours for asthma in the past 12 months

          -  History of adverse reactions to ICS preparations or any of their ingredients

          -  Receiving hyposensitization therapy other than an established maintenance regimen (On
             maintenance regimen for ≥ 3 months)

          -  History of premature birth before 35 weeks gestation