Long-Term Budesonide or Nedocromil Treatment, Once Discontinued, Does Not Alter the Course of Mild to Moderate Asthma in Children and Adolescents

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.

Abbreviations: BMD, Bone mineral density, CAMP, Childhood Asthma Management Program, FEV₁, Forced expiratory volume in one second, FVC, Forced vital capacity, ICS, Inhaled corticosteroids, NAEPP, National Asthma Education and Prevention Program, RR, Relative risk