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.
RCT Entities:
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.
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