The Childhood Asthma Management Program (CAMP) is a multicenter, randomized
, double-masked clinical trial designed to determine the long-term effects
of three inhaled treatments for mild to moderate childhood asthma: budesoni
de (a glucocorticoid used daily) and albuterol (a short-acting beta-agonist
bronchodilator used as needed); nedocromil (a nonsteroid anti-inflammatory
agent used daily) and albuterol; and placebo and albuterol. One thousand f
orty-one children (32% from ethnic minority groups), aged 5 to 12 years at
screening, are currently participating. The primary outcome measure is lung
growth as indicated by postbronchodilator forced expiratory volume in 1 se
cond (FEV1) percent of predicted, observed over 5- to 6-year period. The tr
ial also assesses differences between treatment groups with respect to airw
ay responsiveness, morbidity, physical growth and development, and psycholo
gical growth and development. This report describes the design of the trial
, the rationale for the design choices made, and the methods used to carry
out the trial. (C) Elsevier Science Inc. 1999.