A consortium of investigators at the University of California, San Diego with extensive experience in, and a commitment to, clinical research collaborations in the area of asthma, are proposing two multi-center clinical trials for the NIH-sponsored Asthma Clinical Research Network. The UCSD consortium is led by Drs. Stephen Wasserman and Joe Ramsdell. Study 1 will be undertaken in stable steroid dependent asthmatic adults. It will examine the effect of etanercept, an inhibitor of TNF-alpha, in an 18-week, double-blind, placebo-controlled clinical trial in this population. The primary outcome to be evaluated will be the ability of this agent to permit significant reduction in inhaled steroid dosage without exacerbation. Study 2 will also employ a double-blind, placebo-controlled design. This trial will evaluate the ability of CPAP to improve nocturnal asthma, in a population of overweight, adult patients with moderate-to-severe asthma, who also suffer from sleep disordered breathing. Patients for these, and other Network trials, will be recruited from the Medicine, Pulmonary and Allergy clinics of UCSD, the San Diego VA, the San Diego US Naval Hospital, and Kaiser- Permanente. The available population is large, multi-racial and multi-ethnic, reflecting the San Diego environment. We are also proposing an educational program, under the direction of Dr. Andrew Ries, which will utilize the extensive resources available at UCSD.
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