MONTELUKAST OR AZITHROMYCIN FOR REDUCTION OF INHALED CORTICOSTEROIDS IN CHILD

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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. Patients with persistent asthma are at high risk for side effects from the ICS, encouraging clinicians to seek ways to reduce the steroid burden in their patients. Here we study the steroid sparing effectiveness of two medications, a macrolide (Mac) and a leukotriene receptor antagonist (LTRA) in such patients. Use of Mac has been suggested as treatment for severe asthma as studies in cystic fibrosis demonstrated anti-inflammatory activities of the drugs rather than simply their anti-bacterial properties. Another drug class with possible steroid sparing effects is leukotriene receptor antagonist (LTRA), which improved both markers of airway inflammation and pulmonary function, while reducing beta agonist use, exacerbations, and blood eosinophil counts. MARS is designed to study 210 children (42 per clinical center) in a parallel study design, comparing azithromycin to placebo and montelukast to placebo. The primary outcome variable to determine ICS sparing is 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 best pre-randomization value on 2 consecutive visits 1-4 days apart or (2) an asthma exacerbation as determined by need for systemic corticosteroids.