A Randomized, Double-Blind, Placebo-Controlled, Cross-over Study to Evaluate the Effect of the Leukotriene Antagonist (Singulair©) Plus Moderate Dose Beclomethasone Compared to High Dose Beclomethasone in Obese Subjects With Moderate Persistent Asthma
Subjects will enter the 2-week run-in period after meeting eligibility criteria at the
screening visit (visit 1). During run-in subjects will have all usual asthma medications
discontinued and will be placed on inhaled corticosteroids at moderate doses and leukotriene
receptor antagonists will be withdrawn (LTRA wash-out). Subjects will be monitored to rule
out any acute infection or symptoms consistent with an exacerbation. The run-in period will
be used to assess subject compliance and understanding of study related procedures.
Following the run-in, to be eligible for the randomization subjects must have an ACQ score
>1.25 on the Juniper Asthma Control Questionnaire.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
Determine the effect of montelukast / moderate dose ICS versus high dose ICS on asthma control as measured by the asthma control questionnaire.
United States: Institutional Review Board
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