MARS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Principal hypothesis: In children with moderate to severe persistent asthma, a macrolide (Mac) or a leukotriene receptor antagonist (LTRA) will provide a steroid-sparing effect when compared to placebo as the dose of inhaled corticosteroid (ICS) is reduced. This will be tested following achievement of control of symptoms with moderate to high dose ICS in combination with a long acting beta agonist (LABA). Use of these ICS doses will be based on NHLBI step-up guidelines to achieve asthma control. The primary outcome variable to determine ICS sparing will be the time to reappearance of criteria of inadequate asthma control as the dose of ICS is reduced. Inadequate asthma control is defined as either (1) chronic poor control: (a) symptoms, or albuterol use for symptoms or low peak flow, or peak flow <80% baseline on >3 days per week on average, or b) nocturnal awakenings for asthma symptoms requiring albuterol 2 or more nights over 2 weeks of observation, or c) FEV1 <80% of the randomization value on 2 consecutive visits 1-4 days apart of (2) an asthma exacerbation as determined by need for systemic corticosteroids.