The Childhood Asthma Management Program (CAMP) is a multi-center, randomized, masked clinical trial designed to determine the long-term effects of three 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), age 5-12 at screening are participating. The primary outcome measure is lung growth as indicated by FEV1 over a 5-6 year period. Differences between treatment groups with respect to airway hyper-responsiveness, 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 December 31, 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 three objectives: 1) Data collection at three 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 dairy recording and attendance at scheduled visits; and 3) management by phone and visit of asthma flares, including interaction with pediatricians and other primary care givers. Performance at this center has been above average for the eight center trial in that no patients have been formally dropped out or lost to follow-up. Thirteen patients have been placed on Beclomethasone therapy because of asthma severity as is allowed under the protocol. This indicates that recruitment efforts were effective in selecting appropriate patients for this trial. It is now anticipated that the follow-up procedures and treatment will continue at least through December 31, 1999.
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