Dg. Tinkelman et al., AEROSOL BECLOMETHASONE DIPROPIONATE COMPARED WITH THEOPHYLLINE AS PRIMARY-TREATMENT OF CHRONIC, MILD TO MODERATELY SEVERE ASTHMA IN CHILDREN, Pediatrics, 92(1), 1993, pp. 64-77
Objective, To compare the benefits and adverse reactions of theophylli
ne and beclomethasone (BDP) in the long-term control of mild to modera
te chronic asthma in children. Design. Multicentered, double-blind, do
uble-placebo, randomized, controlled trial. Patients. One hundred nine
ty-five children between the ages of 6 and 16 years with mild to moder
ate asthma. Intervention. Treatment with either BDP, 84 mug four times
a day, or sustained-release theophylline administered twice daily in
doses adjusted for optimum control of symptoms. Main outcome measures.
Daily diary record of symptoms, peak flow rates, supplemental broncho
dilator and glucocorticoid treatment, doctor and hospital visits, abse
nce from work and school, and side effects. Results. Aerosol BDP and s
ustained-release theophylline were effective primary treatments for mi
ld to moderate chronic asthma. Beclomethasone resulted in comparable s
ymptom control with less bronchodilator use and fewer courses of syste
mic steroids than did theophylline. Side effects were observed signifi
cantly more frequently with theophylline than with BDP. Growth velocit
y suppression was noted with BDP and was more pronounced in boys. Supp
ression was not associated with alterations in cortisol measurements e
ither at baseline or following stimulation. Conclusions. Both theophyl
line and BDP are effective therapy for mild to moderate asthma. Cautio
n must be used with the administration of BDP in children because of p
ossible growth velocity suppression.