This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator.
The specific aim of the proposed research is to conduct a multicenter, randomized, double-masked, 2x2 factorial design, clinical trial comparing montelukast, a leukotriene inhibitor with known efficacy in asthma, to inert placebo. The montelukast and placebo-treated particpants will be further randomized to receive either enhanced presentation of the study treatment designed to increase expectancy of therapeutic benefit compared to neutral presentation. The enhanced presentation group will receive a standardized computer-based presentation about the drug and its benefits as well as brief scripted messages from the clinic staff. An additional randomly assigned fifth treatment group will receive no additional treatment, thereby constituting a usual care control group. The primary outcome measure is the change in daily morning peak expiratory flow rate measured by asthma diary during the four week follow-up compared to a two week baseline. Secondary outcomes include measures of lung function, variability of peak flow, asthma symptoms, control of exacerbations, quality of life, and health care use. This study is part of a collaboration being conducted by the American Lung Association Asthma Clinical Research Centers, a group of 19 study centers throughout the U.S. Each study center has multiple collaborating sites at which subjects will be seen under this protocol. All study visits for our site will take place at the GCRC.
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