Adherence with oral montelukast sodium or fluticasone propionate in a clinical trial

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Adherence With Oral Montelukast Sodium or Fluticasone Propionate in a Clinical Trial

C. S. Rand, A. Bilderback, J. Krishnan, K. Riekert, K. Schiller, for the MIAMI Study Research Group; Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, MD. RATIONALE: Characteristics of asthma therapy such as dosing frequency and mode of delivery may be important determinants of adherence. METHODS: We examined adherence in patients with mild persistent asthma, age 15 to 85 years (N=360), enrolled in a randomized study of oral montelukast sodium (10 mg once daily) or fluticasone propionate (88 µg, 2 puffs twice daily) during a 12-week, double-blind treatment period, followed by a 36-week open-label trial. Adherence was monitored using eDEMTM Monitors for montelukast/placebo and MDIlog® devices for fluticasone/placebo. As prescribed adherence for fluticasone/placebo was defined as two sets of use (2 or more puffs with 3 or more hours between sets). As prescribed adherence for montelukast/placebo was defined as one daily opening. Adherence was averaged across days for each subject, and then the average adherence per subject was averaged across subjects. RESULTS: Subjects used at least one puff of fluticasone/placebo 83.3% of days during the double-blind period. However, subjects used fluticasone/placebo as prescribed or more only 50.3% of the days, compared to as prescribed or greater use of montelukast/placebo 77.1% of the days (P<0.001). CONCLUSIONS: Oral once-daily montelukast/placebo is associated with higher rates of as prescribed adherence compared to twice-daily inhaled fluticasone/placebo. Adherence therefore needs to be accounted for in determining efficacy of different treatments. Funding: Merck & Co., Inc.

Abstracts S157

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J ALLERGY CLIN IMMUNOL VOLUME 113, NUMBER 2