Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations

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