Acute Intervention Management Strategies (AIMS)

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NULL HYPOTHESIS 

Compared with conventional therapy for the management of acute wheezing episodes in young children with intermittent asthma and severe exacerbations, which consists of inhaled bronchodilators followed by the sequential addition of systemic corticosteroids, intervention with an inhaled corticosteroid (ICS) or leukotriene receptor antagonist (LTRA) at the onset of respiratory tract illness (RTI)-associated symptoms will not increase the proportion of episode-free days over the 12-month study period.  

DESIGN 

The AIMS design is a randomized, double-blind, placebo-controlled parallel comparison of three strategies directed at minimizing symptoms of wheezing during acute RTIs in children 12-59 months of age with histories of moderate-severe episodes of wheezing. There is a 2-week observation period to qualify and characterize a child, followed by randomization to one of three treatment groups and a 12-month follow-up period.  When a child displays the first sign of RTI-associated symptoms, the parent/guardian administers one of the following treatment regimens for 7 days: (1) active ICS (Pulmicort Respules^® 1.0 mg bid) and placebo LTRA; (2) active LTRA (Singulair^® 4 mg once daily, granules for children 12-23 months of age and chewable tablets for children 24-59 months of age) and placebo ICS; (3) placebo ICS and placebo LTRA.   All children receive albuterol inhalation treatments four times daily while awake (plus as needed) for the first 48 hours followed by albuterol by inhalation on an as-needed basis.  Additional rescue albuterol treatments may be administered on an as-needed basis, and oral steroids are available as well.  The primary outcome variable is the proportion of episode-free days during the 12-month follow-up period.  Secondary outcome variables include time to initiation of first course of oral steroids, total number of courses of oral steroids, duration and severity of lower respiratory tract symptoms, as reflected by the percentage of episode-free days and symptom scores respectively in the 14-day intervals following initiation of study medication, number of wheezing episodes, time to treatment failure, days missed from daycare, parental work and caregiver quality of life, number of unscheduled visits for acute wheezing episodes, and linear growth.

 RESULTS