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Volume 343:1054-1063 October 12, 2000 Number 15 Next

	Full Text PDF Editorial by Wohl, M. E. B. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Antiinflammatory therapies, such as inhaled corticosteroids or nedocromil, are recommended for children with asthma, although there is limited information on their long-term use.

Methods We randomly assigned 1041 children from 5 through 12 years of age with mild-to-moderate asthma to receive 200 µg of budesonide (311 children), 8 mg of nedocromil (312 children), or placebo (418 children) twice daily. We treated the participants for four to six years. All children used albuterol for asthma symptoms.

Results There was no significant difference between either treatment and placebo in the primary outcome, the degree of change in the forced expiratory volume in one second (FEV₁, expressed as a percentage of the predicted value) after the administration of a bronchodilator. As compared with the children assigned to placebo, the children assigned to receive budesonide had a significantly smaller decline in the ratio of FEV₁ to forced vital capacity (FVC, expressed as a percentage) before the administration of a bronchodilator (decline in FEV₁:FVC, 0.2 percent vs. 1.8 percent). The children given budesonide also had lower airway responsiveness to methacholine, fewer hospitalizations (2.5 vs. 4.4 per 100 person-years), fewer urgent visits to a caregiver (12 vs. 22 per 100 person-years), greater reduction in the need for albuterol for symptoms, fewer courses of prednisone, and a smaller percentage of days on which additional asthma medications were needed. As compared with placebo, nedocromil significantly reduced urgent care visits (16 vs. 22 per 100 person-years) and courses of prednisone. The mean increase in height in the budesonide group was 1.1 cm less than in the placebo group (22.7 vs. 23.8 cm, P=0.005); this difference was evident mostly within the first year. The height increase was similar in the nedocromil and placebo groups.

Conclusions In children with mild-to-moderate asthma, neither budesonide nor nedocromil is better than placebo in terms of lung function, but inhaled budesonide improves airway responsiveness and provides better control of asthma than placebo or nedocromil. The side effects of budesonide are limited to a small, transient reduction in growth velocity.

Source Information

Stanley Szefler, M.D., Scott Weiss, M.D., and James Tonascia, Ph.D., take responsibility for the content of this article. The other members of the writing committee were N. Franklin Adkinson, M.D., Bruce Bender, Ph.D., Reuben Cherniack, M.D., Michele Donithan, M.H.S., H. William Kelly, Pharm.D., Joseph Reisman, M.D., M.B.A., Gail G. Shapiro, M.D., Alice L. Sternberg, Sc.M., Robert Strunk, M.D., Virginia Taggart, M.P.H., Mark Van Natta, M.H.S., Robert Wise, M.D., Margaret Wu, Ph.D., and Robert Zeiger, M.D., Ph.D. Dr. Szefler has served as a consultant or advisory panel member for Astra USA, Glaxo Wellcome, Merck, 3M Pharmaceuticals, and Sepracor.

Address reprint requests to Dr. Tonascia at the CAMP Coordinating Center, Johns Hopkins University, 615 N. Wolfe St., Rm. 5010, Baltimore, MD 21205.

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