{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T14:05:56Z","timestamp":1777385156280,"version":"3.51.4"},"reference-count":24,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2009,9,1]],"date-time":"2009-09-01T00:00:00Z","timestamp":1251763200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Am J Rhinol\ufffdAllergy"],"published-print":{"date-parts":[[2009,9]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Azelastine nasal spray is a topical antihistamine with a distinctive taste that may be objectionable to some patients. The primary objectives of this clinical trial were (1) to determine if a reformulated azelastine nasal spray (Astepro) with sucralose as a taste-masking agent provides comparable efficacy to the original formulation (Astelin) and (2) to evaluate dose\u2013response relationships between groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Eight hundred thirty-five patients with seasonal allergic rhinitis were randomized to six treatment groups: (1) original azelastine nasal spray, 1 spray\/nostril b.i.d.; (2) reformulated azelastine, 1 spray\/nostril b.i.d.; (3) placebo, 1 spray\/nostril b.i.d.; (4) original azelastine nasal spray, 2 sprays\/nostril b.i.d., (5) reformulated, 2 sprays\/nostril b.i.d.; and (6) placebo, 2 sprays\/nostril b.i.d. The primary efficacy variable was the change from baseline to day 14 in total nasal symptom score (TNSS) consisting of runny nose, sneezing, itchy nose, and nasal congestion.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Original azelastine nasal spray and the reformulated spray produced comparable improvements in the TNSS at both dosages. There was a dose-related difference in TNSS comparing the 1- and 2-spray dosages. The percentage changes from baseline in the TNSS in the 2-sprays\/nostril dosage groups were 27.9% (p &lt; 0.001) with the reformulated nasal spray, 23.5% (p &lt; 0.01) with the original formulation, and 15.4% with placebo. The incidence of bitter taste was 7% with the reformulated spray and 8% with the original at the 2-sprays\/nostril dosage.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The results of this study showed efficacy both with original azelastine nasal spray and with the reformulated nasal spray and a clear dose\u2013response difference between the 1- and 2-spray dosages.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2500\/ajra.2009.23.3396","type":"journal-article","created":{"date-parts":[[2010,2,10]],"date-time":"2010-02-10T20:34:00Z","timestamp":1265834040000},"page":"512-517","source":"Crossref","is-referenced-by-count":18,"title":["Double-Blind, Placebo-Controlled Trial of Reformulated Azelastine Nasal Spray in Patients with Seasonal Allergic Rhinitis"],"prefix":"10.1177","volume":"23","author":[{"given":"Jonathan A.","family":"Bernstein","sequence":"first","affiliation":[{"name":"Bernstein Clinical Research Center, Cincinnati, Ohio"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruce","family":"Prenner","sequence":"additional","affiliation":[{"name":"Allergy Associates Medical Group, San Diego, California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Berrylin J.","family":"Ferguson","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology Eye and Ear Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jay","family":"Portnoy","sequence":"additional","affiliation":[{"name":"Children's Mercy Hospital, Kansas City, Missouri"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William J.","family":"Wheeler","sequence":"additional","affiliation":[{"name":"Meda Pharmaceuticals, Somerset, New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harry J.","family":"Sacks","sequence":"additional","affiliation":[{"name":"Meda Pharmaceuticals, Somerset, New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2009,9,1]]},"reference":[{"key":"bibr1-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1185\/030079907X226302"},{"key":"bibr2-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1016\/0091-6749(89)90013-4"},{"key":"bibr3-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1159\/000235002"},{"key":"bibr4-ajra.2009.23.3396","first-page":"1143","volume":"48","author":"Ito H.","year":"1998","journal-title":"Arzneimittelforschung"},{"key":"bibr5-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1016\/S0091-6749(96)80196-5"},{"key":"bibr6-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.2500\/105065897781751901"},{"key":"bibr7-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2222.1993.tb02486.x"},{"key":"bibr8-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1016\/S0091-6749(96)80196-5"},{"key":"bibr9-ajra.2009.23.3396","first-page":"65","volume":"50","author":"Inoue Y.","year":"1983","journal-title":"Nichi Idaishi"},{"key":"bibr10-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1016\/S1081-1206(10)62352-6"},{"key":"bibr11-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1016\/S1081-1206(10)60408-5"},{"key":"bibr12-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.2500\/ajr.2007.21.3058"},{"key":"bibr13-ajra.2009.23.3396","volume-title":"Astelin package insert.","year":"2009"},{"key":"bibr14-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1517\/17425250802670474"},{"key":"bibr15-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2222.1991.tb00807.x"},{"key":"bibr16-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1016\/S0091-6749(96)70135-5"},{"key":"bibr17-ajra.2009.23.3396","volume-title":"Allergic rhinitis: Clinical development programs for drug products.","author":"Guidance for Industry.","year":"2000"},{"key":"bibr18-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1016\/S1081-1206(10)60663-1"},{"key":"bibr19-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1053\/ai.1994.v94.a54939"},{"key":"bibr20-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2222.1998.0280s6034.x"},{"key":"bibr21-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1016\/S0091-6749(97)90000-2"},{"key":"bibr22-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2005.04.012"},{"key":"bibr23-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1016\/S1081-1206(10)60804-6"},{"key":"bibr24-ajra.2009.23.3396","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2008.06.003"}],"container-title":["American Journal of Rhinology &amp; 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