Available Data

Available data in the BioLINCC CAMP data package include the Childhood Asthma Management Program clinical trial and first continuation study, CAMP CS. The dataset was last updated on March 2015 to additionally include data from the second and third continuation studies, CAMP CS2 and CS3. The three continuation studies extended follow-up of the clinical trial cohort for an additional 4.5, 3.75, and 4 years respectively to observe asthma progression.

Objectives

The Childhood Asthma Management Program was designed to evaluate whether continuous, long-term treatment (over a period of four to six years) with either an inhaled corticosteroid (budesonide) or an inhaled noncorticosteroid drug (nedocromil) safely produces an improvement in lung growth as compared with treatment for symptoms only (with albuterol and, if necessary, prednisone, administered as needed). The primary outcome in the study was lung growth, as assessed by the change in forced expiratory volume in one second (FEV1, expressed as a percentage of the predicted value) after the administration of a bronchodilator. Secondary outcomes included the degree of airway responsiveness, morbidity, physical growth, and psychological development.

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.

Participants

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

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. (NEJM 2000;343:1054-1063)

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