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Original Research: ASTHMA |

The Effect of Montelukast on Bronchial Hyperreactivity in Preschool Children*

Fahed Hakim, MD; Daphna Vilozni, PhD; Adi Adler, MD; Galit Livnat, MD; Asher Tal, MD; Lea Bentur, MD
Author and Funding Information

*From the Pediatric Pulmonology Unit (Drs. Hakim, Vilozni, Adler, Livnat, and Bentur), Meyer Children’s Hospital, Rambam Medical Center, Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel; and Soroka University Medical Center (Dr. Tal), Beer Sheva, Israel.

Correspondence to: Lea Bentur, MD, Director, Pediatric Pulmonology Unit, Meyer Children’s Hospital, Rambam Medical Center, PO Box 9602, Haifa, 31092 Israel; e-mail: l_bentur@rambam.health.gov.il



Chest. 2007;131(1):180-186. doi:10.1378/chest.06-1402
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Introduction: The effect of montelukast therapy on bronchial hyperreactivity (BHR) as measured by the methacholine challenge test in preschool children has not yet been reported.

Objective: To determine the effect of montelukast (4 mg/d) on BHR as evaluated by a provocative concentration of a substance causing a 20% fall in FEV1 (PC20) values in preschool asthmatic children.

Patients: A total of 26 preschool children (8 girls) aged 3.3 to 6.0 years (mean [± SD] age, 4.7 ± 0.8 years) with mild asthma.

Design: Double-blind randomized, placebo controlled, crossover study. Each child received 4 weeks of treatment with 4 mg of either montelukast or placebo separated by a 2-week washout period. Primary outcomes were PC20 values and the stage number (triple dose) at which FEV1 values dropped by 20%. Post-montelukast therapy PC20 was compared to those for the post-placebo period.

Results: Following 4 weeks of montelukast treatment, the mean PC20 was 4.79 ± 4.69 mg/mL, while after 4 weeks of placebo the mean PC20 was 2.07 ± 2.37 mg/mL (p = 0.001). The montelukast/placebo ratio for PC20 was 2.56 with a 95% confidence interval (CI) of 1.71 to 3.99. The median difference in stage was one triple dose with a 95% CI of 0.5 to 1.5.

Conclusions: Four weeks of treatment with montelukast resulted in a decreased BHR compared with placebo.

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