This seeks to establish an interactive asthma clinical research group at Thomas Jefferson University. The overall goal of participating as part of a collaborative, multi-centered network is to explore novel approaches to the treatment of asthma and to create avenues for disseminating information gained from this research. The Jefferson Clinical Research Group would be based on existing comprehensive and multi-disciplinary research and clinical programs in asthma. Two protocols are proposed to evaluate novel approaches to the treatment of asthma. The first protocol examines the effects of colchicine in the long-term management of severe, steroid-dependent asthma. This is a double-blind, randomized, two-year study using numbers of hospitalizations, doctors' visits, and steroid requirements as primary efficacy measures. The second protocol is designed to define the anti-inflammatory potential of a leukotriene-D4 receptor antagonist and a 5-Lipoxygenase inhibitor and to determine whether either compound can serve as a corticosteroid substitute. For this study, the inflammatory component of asthma is defined as that component which is unresponsive to bronchodilator therapy, but responsive to steroid therapy. This is a double-blind, randomized fourteen-week study using pulmonary function, symptoms, and other drug use as primary outcome measures. A further aim of this proposal is to develop a patient stratification scheme based on clinical, demographic, and laboratory data with the goal of identifying subgroups of asthmatics who are most likely to benefit from a specific intervention and also to gain information regarding disease pathogenesis. The basic premise of this application is that asthma is not a single nosologic entity; rather, it is a syndrome comprising multiple disorders having common clinical manifestations but their own distinct pathogenetic mechanisms. Studies attempting to discern these differences are critical not only to achieve a better understanding of asthma, but also to enhance our ability to recognize the benefits of newer and more specific antiasthmatic agents.
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