The Childhood Asthma Management Program (CAMP) is a multi-center, randomized, masked clinical trial designed to determine the long-term effects of 3 daily treatments for mild to moderate childhood asthma: Budesonide, Nedocromil and placebo. Each participant uses a short-acting bronchodilator (albuterol), as needed. One thousand forty-one children (1,041, 31% ethnic minorities), aged 5-12 years at screening, are participating. The primary outcome measure is lung growth as indicated by FEV1 over a 5-6 year period. Differences between treatment gropus with respect to airway hyperresponsiveness, morbidity, physical growth and development, and psychological growth and development will also be assessed. recruitment under this protocol began in december, 1993, and continued through June, 1995. the Baltimore CAMP study group recruited 128 children (59% male; 21% minorities). The treatment phase of the protocol is now underway and will continue through October, 1999. This study is under the overall supervision of a coordinating center (Johns Hopkins University School of Hygiene and Public Health) and a Data Safety and Monitoring Committee which reports to the NHLBI. Efforts under the protocol are currently aimed at 3 objectives: 1) data collection at htree visits per year as described by the protocol; 2) intermittent contact with all subjects to reinforce good study procedures, compliance with daily medication taking and diary recording and attendance at scheduled visists; and 3) management by phone and visit of asthma flares, including interaction with pediatricinas and other primary care givers. Performance at this center has been above average for the eight center trial in that only three subjects have been formally dropped out or lost to follow-up. Fourteen patients have been placed on beclomethasone therapy because of asthma svereity as allowed under the protocol. This indicates that the recruitment effort was effective in selecting appropriate patients for this trial. Follow-up procedures will continue through October, 1999. A transitional phase-out of treatment has been approved by the IRB and will commence March 1, 1999.
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