{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T14:16:42Z","timestamp":1793110602691,"version":"4.5.0"},"reference-count":18,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2009,5,15]],"date-time":"2009-05-15T00:00:00Z","timestamp":1242345600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pediatric Pulmonology"],"published-print":{"date-parts":[[2009,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Montelukast is a potent leukotriene\u2010receptor antagonist administered once daily that provides clinical benefit in the treatment of asthma and allergic rhinitis in children and adults. Because of its wide use as a pediatric controller, there is a need for a further review of the safety and tolerability of montelukast in children.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To summarize safety and tolerability data for montelukast from previously reported as well as from unpublished placebo\u2010controlled, double\u2010blind, pediatric studies and their active\u2010controlled open\u2010label extension\/extended studies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>These studies evaluated 2,751 pediatric patients 6 months to 14 years of age with persistent asthma, intermittent asthma associated with upper respiratory infection, or allergic rhinitis. These patients were enrolled in seven randomized, placebo\u2010controlled, double\u2010blind registration and post\u2010registration studies and three active\u2010controlled open\u2010label extension\/extended studies conducted by Merck Research Laboratories between 1995 and 2004.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Montelukast was well tolerated in all studies. Clinical and laboratory adverse experiences for patients treated with montelukast were generally mild and transient. The most frequent clinical adverse events for all treatments (placebo, montelukast, active control\/usual care) in virtually all studies were upper respiratory infection, worsening asthma, pharyngitis, and fever.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The clinical and laboratory safety profile for montelukast was similar to that observed for placebo or active control\/usual care therapies. The safety profile of montelukast did not change with long\u2010term use. Pediatr Pulmonol. 2009; 44:568\u2013579. \u00a9 2009 Wiley\u2010Liss, Inc.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ppul.21018","type":"journal-article","created":{"date-parts":[[2009,5,15]],"date-time":"2009-05-15T15:10:10Z","timestamp":1242400210000},"page":"568-579","source":"Crossref","is-referenced-by-count":64,"title":["Safety and tolerability of montelukast in placebo\u2010controlled pediatric studies and their open\u2010label extensions"],"prefix":"10.1002","volume":"44","author":[{"given":"Hans","family":"Bisgaard","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Skoner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria L.","family":"Boza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carol A.","family":"Tozzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen","family":"Newcomb","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Theodore F.","family":"Reiss","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Knorr","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gertrude","family":"Noonan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2009,5,15]]},"reference":[{"key":"e_1_2_1_2_2","doi-asserted-by":"publisher","DOI":"10.1542\/peds.108.3.e48"},{"key":"e_1_2_1_3_2","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-200767060-00005"},{"key":"e_1_2_1_4_2","doi-asserted-by":"publisher","DOI":"10.1586\/1744666X.1.3.325"},{"key":"e_1_2_1_5_2","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.8.13.2173"},{"key":"e_1_2_1_6_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2222.2001.00969.x"},{"key":"e_1_2_1_7_2","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200407-894OC"},{"key":"e_1_2_1_8_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1472-9725.2001.t01-1-00012.x"},{"key":"e_1_2_1_9_2","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-200059040-00015"},{"key":"e_1_2_1_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1081-1206(10)61377-4"},{"key":"e_1_2_1_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(98)70281-1"},{"key":"e_1_2_1_12_2","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200207-747OC"},{"key":"e_1_2_1_13_2","doi-asserted-by":"publisher","DOI":"10.1185\/030079905X48456"},{"key":"e_1_2_1_14_2","doi-asserted-by":"publisher","DOI":"10.1002\/ppul.20666"},{"key":"e_1_2_1_15_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.279.15.1181"},{"key":"e_1_2_1_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2004.11.010"},{"key":"e_1_2_1_17_2","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2004-1172"},{"key":"e_1_2_1_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1081-1206(10)61342-7"},{"key":"e_1_2_1_19_2","first-page":"1","volume-title":"Guidance for Industry E6\u2010Good Clinical Practice: Consolidated Guidance","author":"Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research","year":"1996"}],"container-title":["Pediatric Pulmonology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fppul.21018","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fppul.21018","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ppul.21018","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,7]],"date-time":"2023-10-07T22:17:27Z","timestamp":1696717047000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ppul.21018"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2009,5,15]]},"references-count":18,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2009,6]]}},"alternative-id":["10.1002\/ppul.21018"],"URL":"https:\/\/doi.org\/10.1002\/ppul.21018","archive":["Portico"],"relation":{},"ISSN":["8755-6863","1099-0496"],"issn-type":[{"value":"8755-6863","type":"print"},{"value":"1099-0496","type":"electronic"}],"subject":[],"published":{"date-parts":[[2009,5,15]]}}}