Clinical research studyShort-term and long-term asthma control in patients with mild persistent asthma receiving montelukast or fluticasone: a randomized controlled trial
Section snippets
Recruitment and eligibility
Institutional review boards at each study site (n = 39) approved the study protocol, and patients or guardians gave written informed consent. Participants aged 15 to 85 years with symptoms and albuterol use consistent with mild persistent asthma for at least 4 months, as assessed by questionnaire, were recruited. Eligibility criteria were based on National Asthma Education Prevention Program2 and Global Initiative for Asthma1 definitions of mild persistent asthma. To ensure a true mild
Patient accounting and demographics
Of the 901 participants screened, 735 entered the placebo run-in period, and 400 were randomized to treatment (Figure 2). The most common reasons for exclusion were asthma being either too mild or too severe. Due to a drug packaging error in which either both active drugs (n = 11) or both matching placebos (n = 9) were given, 20 randomized participants were discontinued from the study, and their data were excluded from analyses.
Three hundred eighty (380) patients were randomized to masked
Discussion
Epidemiologic surveys estimate that 20% to 30% of asthma patients in the United States have mild persistent asthma.25, 26, 27, 28, 29 Both Global Initiative for Asthma1 and National Asthma Education Prevention Program2 guidelines recommend daily use of controller therapy for mild persistent asthma, including inhaled corticosteroid and leukotriene modifiers. Few studies comparing different treatment options for mild persistent asthma have been done, because of the challenges in enrolling such
Acknowledgments
The following are members of the MIAMI Study Research Group Steering Committee: James Baker, MD; Steven Bird, MS; John Carl, MD; Jonathan Corren, MD; Jonathan Edelman, MD; Kathleen Harden, RN; Michael Kaplan, MD; Guillermo Mendoza, MD; E. John Orav, PhD; David Pearlman, MD; Cynthia Rand, PhD; Michael Schatz, MD, MS; Robert Zeiger, MD, PhD. We thank Arvinder Mokha, MD, for his assistance in reviewing the spirometry data. We would also like to acknowledge the medical program coordinator,
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This work was supported by Merck & Co., Inc.