Pharm Sci. 2020;26(2): 193-197.
doi: 10.34172/PS.2020.7

Scopus ID: 85089452407
  Abstract View: 290
  PDF Download: 195

Short Communication

Efficacy of Montelukast for Prevention of Upper Respiratory Tract Infection in Children: A Randomized, Placebo-Controlled Trial

Fatemeh Dorreh 1 ORCID logo, Mohammad Hasan Esmaili 1, Parsa Yousefhajian 1, Mahdieh Naziri 1, Aziz Eghbali 2, Bahador Bagheri 3,4* ORCID logo

1 Department of Pediatrics, Amir-Kabir Hospital, Arak University of Medical Sciences, Arak, Iran.
2 Aliasghar Clinical Research Development Center, Iran University of Medical Sciences, Tehran, Iran.
3 Cancer Research Center, Semnan University of Medical Sciences, Semnan, Iran.
4 Department of Pharmacology, Semnan University of Medical Sciences, Semnan, Iran.


Background: Upper Respiratory tract infection (URTI) or common cold is very prevalent in children particularly in young children. Leukotriene receptor antagonists (LTRAs) like montelukast are effective drugs in asthma and some other respiratory diseases. Our purpose was to study preventive effects of montelukast on pediatric URTI.
Methods: This randomized, placebo-controlled, and double blind trial was performed on 450 healthy children aged 1-5 year in Amir Kabir Hospital, Arak, Iran. Children were randomized 1:1 to placebo group or montelukast group for 12 weeks. Number of URTI episodes and duration were the primary end points and were compared at baseline and after termination of treatment.
Results: Mean age was 28 ± 12.3 months. Mean of URTI episodes was 0.7 ± 0.57 in children treated with montelukast and 1.27 ± 0.72 in children treated with placebo, respectively. Differences were statistically significant (P =0.01). A significant difference was seen in URTI duration between two study groups (6.3 ± 6.1 vs 4.1 ± 3.9, P = 0.05). In addition, duration of fever was shorter in children receiving montelukast (P=0.001).
Conclusion: Our study indicates that 3 month treatment with montelukast is effective for reducing the incidence of URTI in young children. This treatment has an acceptable safety without any serious concern.

Keywords: Upper respiratory tract infection, Monteluskat, Children, Fever
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Submitted: 25 Aug 2019
Accepted: 01 Jan 2020
ePublished: 27 Jun 2020
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