Study of montelukast for the treatment of respiratory symptoms of post-respiratory syncytial virus bronchiolitis in children.
BACKGROUND
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.


OBJECTIVE
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).


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 < or = 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.
Bisgaard
Hans
H
Danish Pediatric Asthma Center, Department of Pediatrics, Copenhagen University Hospital, Gentofte, DK-2900 Copenhagen, Denmark. bisgaard@copsac.dk
Flores-Nunez
Alejandro
A
Goh
Anne
A
Azimi
Parvin
P
Halkas
Andrew
A
Malice
Marie-Pierre
MP
Marchal
Jean-Louis
JL
Dass
S Balachandra
SB
Reiss
Theodore F
TF
Knorr
Barbara A
BA
D000085:Acetates / Q000008:administration & dosage / Q000627:therapeutic use*; D001988:Bronchiolitis / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D002675:Child, Preschool; D003521:Cyclopropanes; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D020024:Leukotriene Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D010865:Pilot Projects; D011804:Quinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D018357:Respiratory Syncytial Virus Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D012136:Respiratory Syncytial Viruses / Q000302:isolation & purification*; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013440:Sulfides; D016896:Treatment Outcome
D000085:Acetates; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C093875:montelukast