NULL HYPOTHESIS 

In children with mild-moderate persistent asthma, as defined by symptoms and positive methacholine challenge, treatments for 12 months with (1) an inhaled corticosteroid (ICS), (2) an ICS @ 50% dose combined with a long-acting beta-agonist (LABA), and (3) an oral leukotriene receptor antagonist (LTRA), do not differ in their effects on asthma control, as measured by the percentage of days without asthma. 

DESIGN 

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 ³ 12%), race (Caucasian or non-Caucasian), and methacholine PC₂₀ (< 2 or ³ 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 exacerbations requiring prednisone therapy and the time to the first asthma exacerbation), forced oscillation and spirometry, reversibility (FEV₁ pre- and post 2 puffs of albuterol MDI), methacholine PC₂₀, exhaled nitric oxide, and asthma-related quality of life. 

 RESULTS