{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T09:13:16Z","timestamp":1784193196959,"version":"3.55.0"},"reference-count":36,"publisher":"American Academy of Pediatrics (AAP)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2012,2,1]]},"abstract":"BACKGROUND:<\/jats:title>Infections with viruses causing upper respiratory tract infection (URI) are associated with increased leukotriene levels in the upper airways. Montelukast, a selective leukotriene-receptor antagonist, is an effective treatment of asthma and allergic rhinitis.<\/jats:p><\/jats:sec>OBJECTIVE:<\/jats:title>To determine whether prophylactic treatment with montelukast reduces the incidence and severity of URI in children.<\/jats:p><\/jats:sec>METHODS:<\/jats:title>A randomized, double-blind, placebo-controlled study was performed in 3 primary care pediatric ambulatory clinics in Israel. Healthy children aged 1 to 5 years were randomly assigned in a 1:1 ratio to receive 12-week treatment with 4 mg oral montelukast or look-alike placebo. Patients were excluded if they had a previous history of reactive airway disease. A study coordinator contacted the parents by phone once a week to obtain information regarding the occurrence of acute respiratory episodes. The parents received a diary card to record any acute symptoms of URI. The primary outcome measure was the number of URI episodes.<\/jats:p><\/jats:sec>RESULTS:<\/jats:title>Three hundred children were recruited and randomly assigned into montelukast (n = 153) or placebo (n = 147) groups. One hundred thirty-one (85.6%) of the children treated with montelukast and 129 (87.7%) of the children treated with placebo completed 12 weeks of treatment. The number of weeks in which URI was reported was 30.4% in children treated with montelukast and 30.7% in children treated with placebo. There was no significant difference in any of the secondary variables between the groups.<\/jats:p><\/jats:sec>CONCLUSIONS:<\/jats:title>In preschool-aged children, 12-week treatment with montelukast, compared with placebo, did not reduce the incidence of URI.<\/jats:p><\/jats:sec>","DOI":"10.1542\/peds.2011-0358","type":"journal-article","created":{"date-parts":[[2012,1,5]],"date-time":"2012-01-05T20:00:59Z","timestamp":1325793659000},"page":"e285-e290","source":"Crossref","is-referenced-by-count":11,"title":["RCT of Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children"],"prefix":"10.1542","volume":"129","author":[{"given":"Eran","family":"Kozer","sequence":"first","affiliation":[{"name":"Pediatric Emergency Unit, and"},{"name":"Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zachi","family":"Lotem","sequence":"additional","affiliation":[{"name":"Pediatric Ambulatory Center, Clalit Health Services, Ramla, Israel;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahmud","family":"Elgarushe","sequence":"additional","affiliation":[{"name":"Clalit Health Services, Ramla, Israel;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rafael","family":"Torgovicky","sequence":"additional","affiliation":[{"name":"Merck Sharp & Dohme (MSD) Company, Petah Tikva, Israel; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raanan","family":"Cohen","sequence":"additional","affiliation":[{"name":"Merck Sharp & Dohme (MSD) Company, Petah Tikva, Israel; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Herman A.","family":"Cohen","sequence":"additional","affiliation":[{"name":"Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel;"},{"name":"Pediatric Ambulatory Center, Clalit Health Services, Petah Tikva, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matitiahu","family":"Berkovitch","sequence":"additional","affiliation":[{"name":"Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel;"},{"name":"Clinical Pharmacology and Toxicology Unit, Assaf Harofeh Medical Center, Zerifin, Israel;"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[2012,2,1]]},"reference":[{"issue":"6","key":"2021120903102250400_B1","doi-asserted-by":"crossref","first-page":"757","DOI":"10.1086\/322627","article-title":"Excessive antibiotic use for acute respiratory infections in the United States","volume":"33","author":"Gonzales","year":"2001","journal-title":"Clin Infect Dis"},{"issue":"4","key":"2021120903102250400_B2","doi-asserted-by":"crossref","first-page":"320","DOI":"10.1067\/mem.2000.109341","article-title":"Antibiotic prescribing for patients with colds, upper respiratory tract infections, and bronchitis: a national 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