{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T11:14:37Z","timestamp":1777374877270,"version":"3.51.4"},"reference-count":23,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2018,1,1]],"date-time":"2018-01-01T00:00:00Z","timestamp":1514764800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Allergy\ufffdRhinol (Providence)"],"published-print":{"date-parts":[[2018,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>This study evaluated the efficacy of montelukast in reducing seasonal allergic rhinitis symptoms in Japanese children with Japanese cedar (JC) pollinosis induced in an artificial exposure chamber (OHIO Chamber).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Pediatric patients aged 10 to 15 years sensitive to JC pollen entered a randomized, double-blind, single-site, crossover study. After confirmation of an allergic response to a JC pollen exposure for 3 hours in the OHIO Chamber during the screening period, subjects received either montelukast 5 mg chewable tablets or placebo for a 7-day treatment period, followed by a 3-hour pollen exposure in the chamber. After a 7-day washout period, subjects crossed over to the other treatment. Subjects were instructed to self-assess their nasal symptoms using 5-point scale for every 30 minutes. The primary end point was the change from baseline (just before entering the exposure chamber for each exposure) in total nasal symptom score (TNSS; the sum of nasal congestion, nasal discharge, and sneezing scores) over 3 hours of pollen exposure. Adverse events (AEs) were evaluated throughout the study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 220 subjects (median age, 12 years) received treatment. For TNSS, the between-group difference in the change (95% confidence interval) was \u22120.01 (\u22120.11 to 0.10); the change between placebo and montelukast 5 mg was not significant. TNSS in the screening and treatment periods after receiving placebo for 7 days was 1.58 and 1.31, respectively, suggesting a placebo response. On account of high placebo response, a post hoc analysis was conducted. The analysis in a subgroup of subjects who did not show placebo response demonstrated a difference in the efficacy between montelukast and placebo (nominal P\u2009&lt;\u2009.037). The most common AE was positive urine protein (4.6% with montelukast vs 7.8% with placebo).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Although montelukast was well tolerated, this study did not demonstrate a treatment difference between active drug and placebo in Japanese children exposed to JC pollen in the OHIO Chamber. Trial Registry: ClinicalTrials.gov, NCT01852812<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/2152656718783599","type":"journal-article","created":{"date-parts":[[2018,7,13]],"date-time":"2018-07-13T04:56:21Z","timestamp":1531457781000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["Evaluation of Montelukast for the Treatment of Children With Japanese Cedar Pollinosis Using an Artificial Exposure Chamber (OHIO Chamber)"],"prefix":"10.1177","volume":"9","author":[{"given":"Kazuhiro","family":"Hashiguchi","sequence":"first","affiliation":[{"name":"Department of Otorhinolaryngology, Futaba Clinic, Tokyo, Japan"},{"name":"Medical Corporation Shinanokai, Samoncho Clinic, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kimihiro","family":"Okubo","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology, Nippon Medical School Hospital, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoichi","family":"Inoue","sequence":"additional","affiliation":[{"name":"MSD K.K., Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hirotaka","family":"Numaguchi","sequence":"additional","affiliation":[{"name":"MSD K.K., Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kumi","family":"Tanaka","sequence":"additional","affiliation":[{"name":"MSD K.K., Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nobuyuki","family":"Oshima","sequence":"additional","affiliation":[{"name":"MSD K.K., Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anish","family":"Mehta","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, New Jersey, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chisato","family":"Nishida","sequence":"additional","affiliation":[{"name":"MSD K.K., Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Itori","family":"Saito","sequence":"additional","affiliation":[{"name":"MSD K.K., Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"George","family":"Philip","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc., Kenilworth, New Jersey, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2018,7,13]]},"reference":[{"key":"bibr1-2152656718783599","doi-asserted-by":"publisher","DOI":"10.2500\/aap2008.29.3072"},{"key":"bibr2-2152656718783599","doi-asserted-by":"publisher","DOI":"10.1111\/j.1651-2227.2009.01304.x"},{"key":"bibr3-2152656718783599","doi-asserted-by":"publisher","DOI":"10.5415\/apallergy.2012.2.2.93"},{"key":"bibr4-2152656718783599","doi-asserted-by":"publisher","DOI":"10.1016\/S1081-1206(10)60527-3"},{"key":"bibr5-2152656718783599","doi-asserted-by":"publisher","DOI":"10.1016\/j.alit.2016.11.001"},{"key":"bibr6-2152656718783599","doi-asserted-by":"publisher","DOI":"10.1007\/s11882-015-0564-7"},{"key":"bibr7-2152656718783599","doi-asserted-by":"publisher","DOI":"10.1016\/S0194-5998(03)00601-6"},{"key":"bibr8-2152656718783599","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijporl.2013.10.006"},{"key":"bibr9-2152656718783599","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2222.2003.01786.x"},{"key":"bibr10-2152656718783599","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2222.2006.02498.x"},{"key":"bibr11-2152656718783599","doi-asserted-by":"publisher","DOI":"10.1159\/000189197"},{"key":"bibr12-2152656718783599","doi-asserted-by":"publisher","DOI":"10.2332\/allergolint.O-06-453"},{"key":"bibr13-2152656718783599","doi-asserted-by":"publisher","DOI":"10.2332\/allergolint.O-07-515"},{"key":"bibr14-2152656718783599","doi-asserted-by":"publisher","DOI":"10.2332\/allergolint.O-08-533"},{"key":"bibr15-2152656718783599","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2222.2002.01422.x"},{"key":"bibr16-2152656718783599","doi-asserted-by":"publisher","DOI":"10.1016\/S1081-1206(10)62144-8"},{"key":"bibr17-2152656718783599","doi-asserted-by":"publisher","DOI":"10.1016\/S1081-1206(10)61576-1"},{"key":"bibr18-2152656718783599","doi-asserted-by":"publisher","DOI":"10.1046\/j.1398-9995.2003.00261.x"},{"key":"bibr19-2152656718783599","doi-asserted-by":"publisher","DOI":"10.2500\/aap.2012.33.3517"},{"key":"bibr20-2152656718783599","unstructured":"Biopharmaceutical Testing and Analysis of ONO-1078 Dry Syrup 10% Formulation. 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