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Study of Montelukast for the Treatment of Respiratory Symptoms of Post–Respiratory Syncytial Virus Bronchiolitis in Children

¹ Danish Pediatric Asthma Center, Copenhagen University Hospital, Copenhagen, Denmark; ² Department of Pediatric Pulmonology, Hospital para el Niño Poblano, Puebla, Mexico; ³ Department of Pediatric Medicine, KK Women's and Children's Hospital, Singapore; ⁴ Children's Hospital of Oakland, Oakland, California; ⁵ Pediatric Pulmonology, Netcare Krugersdorp Hospital, Johannesburg, South Africa; and ⁶ Merck Research Laboratories, Rahway, New Jersey

Correspondence and requests for reprints should be addressed to Hans Bisgaard, M.D., Danish Pediatric Asthma Center, Department of Pediatrics, Copenhagen University Hospital, Gentofte, DK-2900 Copenhagen, Denmark. E-mail: bisgaard{at}copsac.dk

Rationale: A pilot study (Bisgaard H; Study Group on Montelukast and Respiratory Syncytial Virus. A randomized trial of montelukast in respiratory syncytial virus postbronchiolitis. Am J Respir Crit Care Med 2003;167:379–383) reported the efficacy of montelukast in post–respiratory syncytial virus (RSV) bronchiolitic respiratory symptoms.

Objectives: To evaluate the efficacy and safety of montelukast, 4 and 8 mg, in treating recurrent respiratory symptoms of post-RSV bronchiolitis in children in a large, multicenter study.

Methods: This was a double-blind study of 3- to 24-month-old children who had been hospitalized for a first or second episode of physician-diagnosed RSV bronchiolitis and who tested positive for RSV. Patients (n = 979) were randomized to placebo or to montelukast at 4 or 8 mg/day for 4 weeks (period I) and 20 weeks (period II). The primary end point was percentage symptom-free days (%SFD; day with no daytime cough, wheeze, and shortness of breath, and no nighttime cough).

Measurements and Main Results: No significant differences were seen between montelukast and placebo in %SFD over period I: mean ± SD for placebo and for montelukast at 4 and 8 mg were 37.0 ± 30.7, 38.6 ± 30.4, and 38.5 ± 29.9, respectively. Least-squares mean differences (95% confidence interval) between montelukast (4 mg) and placebo and between montelukast (8 mg) and placebo were 1.9% (–2.9, 6.7) and 1.6% (–3.2, 6.5), respectively. Secondary end points were similar across treatments. Both doses were generally well tolerated. During the first two treatment weeks, average %SFD was approximately 29%. In post hoc analyses of patients (n = 523) with persistent symptoms (%SFD 30% over Weeks 1–2), differences in %SFD were seen between montelukast and placebo over Weeks 3–24: difference were 5.7 (0.0, 11.3) for montelukast (4 mg) minus placebo and 5.9 (0.1, 11.7) for montelukast (8 mg) minus placebo.

Conclusions: In this study, montelukast did not improve respiratory symptoms of post-RSV bronchiolitis in children.

Clinical trial registered with www.clinicaltrials.gov (NCT00076973).

Key Words: post–respiratory syncytial virus bronchiolitic asthma symptoms • symptom-free days • wheeze • leukotriene receptor antagonist

AT A GLANCE COMMENTARY Scientific Knowledge on the Subject A previous pilot study (n = 130) reported the significant efficacy of montelukast in post-RSV bronchiolitic respiratory symptoms. What This Study Adds to the Field In this study, montelukast did not improve respiratory symptoms of post-RSV bronchiolitis in children.