Long-term budesonide or nedocromil treatment, once discontinued, does not alter the course of mild to moderate asthma in children and adolescents

Abstract

Objectives: To determine whether long-term, continuous use of inhaled anti-inflammatory medications affects asthma outcomes in children with mild to moderate asthma after use is discontinued.

Study design: Of the 1041 participants in the Childhood Asthma Management Program randomized clinical trial, 941 (90%) were followed to determine whether 4.3 years of twice-daily budesonide or nedocromil administration (each compared with placebo) affected subsequent asthma outcomes during a 4.8-year posttrial period in which treatment was managed by the participants' physicians.

Results: The groups treated continuously during the trial with either budesonide or nedocromil did not differ from the group given placebo in terms of lung function, control of asthma, or psychological status at the end of 4.8 years of posttrial follow-up. However, the decreased mean height in the budesonide group relative to the placebo group at the end of the trial (1.1 cm; P = .005) remained statistically significant (0.9 cm; P = .01) after an additional 4.8 years and was more pronounced in girls (1.7 cm; P = .001) than in boys (0.3 cm; P = .49). Participants in all groups used inhaled corticosteroids during 30% of the posttrial period.

Conclusions: Clinically meaningful improvements in the control of asthma and in airway responsiveness achieved during continuous treatment with inhaled corticosteroids do not persist after continuous treatment is discontinued.

Figure

Mean values for measures of morbidity, lung function after the use of a bronchodilator, and bronchodilator reversibility during 9 years of follow-up after randomization to the budesonide, nedocromil, and placebo groups: A, Annual prednisone course rate; B, Annual urgent care visit rate; C, Post bronchodilator FEV₁ % of predicted; D, Post bronchodilator FVC % of predicted; E, Post bronchodilator FEV₁/FVC; F, Bronchodilator reversibility. All data to the left of the vertical line on each graph were obtained during the trial when participants were treated regularly with budesonide 200 mcg bid, nedocromil 4 mg bid, or placebo. All data to the right of the vertical line on each graph were obtained during the post-trial follow-up period after regular treatment with study medications was discontinued.