NHLBI TOPMed: Pediatric Asthma Controller Trial (PACT)

After a 2-4 week assessment/characterization run-in period, 6-14 year-old children who met NAEPP criteria for mild-moderate persistent asthma specifically based on symptom criteria and methacholine PC20 <= 12.5 mg/ml and FEV1 >= 80% were randomized to one of the three active treatment arms for 12 months. Randomization was stratified according to clinical center, bronchodilator response (< 12% or >= 12%), race (Caucasian or non-Caucasian), and methacholine PC20 (< 2 or >= 2 mg/ml). The primary outcome variable was the proportion of asthma-free days during the 12-month treatment period. Secondary outcomes included other measures of asthma control (percentage of rescue-free days, albuterol-free days, and episode-free days; the number of asthma... (for more see dbGaP study page.)