{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T19:58:11Z","timestamp":1789243091532,"version":"build-2803163510"},"reference-count":36,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2020,7,7]],"date-time":"2020-07-07T00:00:00Z","timestamp":1594080000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Experimental Allergy"],"published-print":{"date-parts":[[2020,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Budesonide, a poorly water\u2010soluble corticosteroid, is currently marketed as a suspension. Budesolv is a novel aqueous formulation containing dissolved budesonide showing increased local availability in preclinical models. Budesolv contains ~85% less corticosteroid than the marketed comparator.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>The study (EudraCT:2018\u2010001324\u201019) was designed to assess non\u2010inferiority of Budesolv compared to Rhinocort\u00ae Aqua 64 (RA) and early onset of action.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In a three\u2010way cross\u2010over double\u2010blinded randomized trial, Budesolv 10 was compared to RA and placebo in grass pollen allergic rhinoconjunctivitis volunteers (n\u00a0=\u00a083 (ITT); n\u00a0=\u00a075 (PP)). On day 1, participants entered the Vienna Challenge Chamber (VCC) for 6\u00a0hours; first treatment took place at 1:45\u00a0hours after entry. Participants treated themselves for further 6\u00a0days; on day 8, the last treatment was applied before entering the VCC. Subjective symptom scores, nasal airflow and nasal secretion were measured regularly during allergen challenge.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Budesolv 10 was equally effective compared to RA with respect to TNSS and nasal airflow after eight days of treatment with a strongly reduced dose (more than 80% reduction). After first dose, only Budesolv 10 showed a significant reduction of nasal and respiratory symptoms starting 90\u00a0minutes (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a0.05) and 15\u00a0minutes (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a0.05) after application onwards, respectively, demonstrating an early onset of efficacy. A clinically significant 1 point reduction in nasal symptom score was reached at 195\u00a0minutes (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a0.05) after application.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions and clinical relevance<\/jats:title><jats:p>The novel preservative\u2010free, aqueous low\u2010dose budesonide formulation is highly efficacious even after an initial single treatment. Thus, Budesolv 10 appears to be an effective acute treatment for allergic rhinitis as well as for AR comorbidities like mild asthma and conjunctivitis.<\/jats:p><\/jats:sec>","DOI":"10.1111\/cea.13691","type":"journal-article","created":{"date-parts":[[2020,6,22]],"date-time":"2020-06-22T17:29:08Z","timestamp":1592846948000},"page":"1065-1077","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Fast effectiveness of a solubilized low\u2010dose budesonide nasal spray in allergic rhinitis"],"prefix":"10.1111","volume":"50","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5432-9459","authenticated-orcid":false,"given":"Petra","family":"Zieglmayer","sequence":"first","affiliation":[{"name":"Power Project GmbH Vienna Challenge Chamber  Vienna Austria"},{"name":"Medical University  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ren\u00e9","family":"Schmutz","sequence":"additional","affiliation":[{"name":"Power Project GmbH Vienna Challenge Chamber  Vienna Austria"},{"name":"Medical School Sigmund Freud University  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0262-4047","authenticated-orcid":false,"given":"Patrick","family":"Lemell","sequence":"additional","affiliation":[{"name":"Power Project GmbH Vienna Challenge Chamber  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Unger\u2010Manhart","sequence":"additional","affiliation":[{"name":"Marinomed Biotech AG  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine","family":"Nakowitsch","sequence":"additional","affiliation":[{"name":"Marinomed Biotech AG  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Goessl","sequence":"additional","affiliation":[{"name":"Marinomed Biotech AG  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus","family":"Savli","sequence":"additional","affiliation":[{"name":"Biostatistik &amp; Consulting  Hartberg Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ren\u00e9","family":"Zieglmayer","sequence":"additional","affiliation":[{"name":"Power Project GmbH Vienna Challenge Chamber  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva","family":"Prieschl\u2010Grassauer","sequence":"additional","affiliation":[{"name":"Marinomed Biotech AG  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,7,7]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"AkdisCA HellingsPW AgacheI.Global atlas of allergic rhinitis and chronic rhinosinusitis;2015."},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1034\/j.1398-9995.2002.23664.x"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1067\/mai.2002.121701"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2008.01750.x"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1067\/mai.2000.104550"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/cea.12556"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13223-018-0311-4"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.12903"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.2500\/aap.2016.37.3979"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.4193\/Rhin16.278"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.2500\/aap.2011.32.3444"},{"issue":"102","key":"e_1_2_7_13_1","first-page":"118","article-title":"A solubilized aqueous budesonide formulation showed higher anti\u2010inflammatory therapeutic efficacy in a murine pulmonary inflammation model compared to marketed products","volume":"71","author":"Nakowitsch S","year":"2016","journal-title":"Allergy"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2010.02473.x"},{"key":"e_1_2_7_15_1","volume-title":"R: A language and environment for statistical computing","author":"R Core Team","year":"2017"},{"key":"e_1_2_7_16_1","unstructured":"FDA.Non\u2010Inferiority Clinical Trials to Establish Effectiveness. 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