Although there have been advances in understanding the pathobiology of asthma, the average patient with asthma continues to suffer substantial morbidity. This is somewhat paradoxical since it has been established over and over again that if an asthma sufferer obtains high quality asthma care, the impact of the disease on their life can be minimized. To address this issue an expert panel was convened and practice guidelines for asthma were formulated and promulgated. During this process it became clear that there were many issues related to asthma care for which the data base to make firm and scientifically sound recommendations was minimal. Since the prevalence of asthma is so great and asthma care so costly, it is important and economically sensible to obtain the data needed to make recommendations for treatment that have stood the test of rigorous clinical investigation. Because rigorous clinical investigation is time-consuming and resource intensive it is critical to pose questions in clinical trails that have a substantial likelihood of yielding clearly defined treatment guidelines. Furthermore, such trials should use novel agents in creative protocols that will compare and contrast new and established treatments. In the proposal which follows we present two proposed clinical trials that have the potential to substantively influence asthma care and care costs. In specific the two trials proposed for consideration for performance by the network are: EMERGENCY TREATMENT OF ASTHMA: ADDITION OF A 5-LIPOXYGENASE INHIBITOR A double-blind, placebo controlled trial design will be used to determine if there is an effect of adding 2 weeks of treatment with a 5- lipoxygenase inhibitor to the standard treatment of acute asthma episodes. Lung function 90-120 minutes after starting treatment and need for hospitalization rather than discharge from the emergency service will be the primary endpoints. COMPARISON OF REGULAR VERSUS INTERMITTENT USE OF BETA AGONISTS IN PATIENTS REQUIRING INHALED STEROIDS The safety and efficacy, as reflected in overall asthma control, of recurrent plus """"""""as needed"""""""" beta agonist use will be compared to the use of beta agonists only on an """"""""as needed"""""""" basis in moderately severe asthma patients. A double-blind, placebo controlled trial design will be used in this 12 month treatment trial in patients who require continuous treatment with inhaled steroids for asthma control.
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