Health care education, delivery, and qualityAdherence with montelukast or fluticasone in a long-term clinical trial: Results from the Mild Asthma Montelukast Versus Inhaled Corticosteroid Trial
Section snippets
Recruitment and eligibility
Institutional review boards at each study site (n = 39) approved the study protocol. Patients or guardians gave written informed consent before enrollment, and adolescents gave their assent. Patients age 15 to 85 years with symptoms and albuterol use consistent with mild persistent asthma for at least 4 months on the basis of the National Asthma Education Prevention Program13 and Global Initiative for Asthma14 definitions were recruited as detailed elsewhere.12 Participants were excluded if
Patient demographics
Three hundred eighty patients were randomized to masked treatment with montelukast (N = 189) or fluticasone (N = 191). Patient accounting, presented elsewhere,12 noted the groups were well balanced for all baseline parameters. Patients were predominately female (69.5%), white (80.8%), young (mean age, 35.2 ± 14.3 years), and atopic (79.6%). Mean baseline asthma severity characteristics were consistent with asthma treatment guideline definitions of mild persistent disease and have been
Discussion
We examined adherence to once-daily oral montelukast/placebo compared with adherence with twice-daily inhaled fluticasone/placebo in the same individuals and found that participants were slightly more likely to take at least 1 daily dose of their twice-daily inhaled medication than to take their once-daily dose of oral medication. However, participants were more likely to take the twice-daily inhaled therapy less than prescribed compared with once-daily oral therapy. In fact, inhaled therapy
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Supported by Merck & Co, Inc.
Disclosure of potential conflict of interest: C. Rand has consulting arrangements with Schering Plough; has received grant support from Merck; and is on the speakers' bureau for GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Merck. J. M. Edelman owns stock in and is employed by Merck. C. M. Hustad owns stock in and is employed by Merck. R. S. Zeiger has consulting arrangements with AstraZeneca, Genentech, Glaxo-SmithKline, Merck, Novartis, and Sanofi-Aventis; has received grant support from AstraZeneca, Genentech, GlaxoSmithKline, Merck, Novartis, and Sanofi-Aventis; and has lectured for AstraZeneca. The rest of the authors have declared that they have no conflict of interest.
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A list of the members of the Mild Asthma Montelukast Versus Inhaled Corticosteroid Trial Study Research Group appears at the end of this article.