- Randomized, double blind, placebo controlled trial.1
- Number of patients enrolled at one month of age = 411, number of patients undergoing randomization at mean age of 10.7 months of age (when first episode of wheezing occurred) = 301, number of patients actually receiving treatment = 294.
- Excluded for severe congenital anomaly, gest age < 36 weeks, need for mechanical ventilation, and airway infection prior to enrollment.
- “Wheezing” defined as any symptom severely affecting child’s breathing, manifested as noisy breathing (wheezing, whistling), breathlessness, SOB, or persistent coughing; “episode” defined as wheezing on three consecutive days.
- Budesonide 400mcg daily vs placebo to be given by MDI with spacer at the start of a wheezing episode for total of two weeks.
- Terbutaline used as needed for rescue medication; otherwise, no other asthma medications.
- Patients were monitored and treated if episodes occurred during the first three years of life.
- Discontinued participation if persistent wheezing, defined as five “episodes” within six months, daily symptoms for four weeks, or acute severe symptoms resulting in hospitalization.
- Primary outcomes: proportions of symptom-free days, days free of need for rescue medication, and number of episodes were similar in the two groups.
- Secondary outcomes: percentage of patients discontinued from study due to persistent wheezing, time to study discontinuation, and time between the first and second wheezing episodes were similar between the two groups.