{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T13:05:46Z","timestamp":1767704746427,"version":"3.41.2"},"reference-count":36,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2023,7,13]],"date-time":"2023-07-13T00:00:00Z","timestamp":1689206400000},"content-version":"vor","delay-in-days":12,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical &amp; Translational All"],"published-print":{"date-parts":[[2023,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>House Dust Mite (HDM) is the most common indoor allergen triggering allergic symptoms. First\u2010line pharmacotherapy treatment is recommended in international guidelines, while the avoidance of allergens represents a still unmet guideline principle. AM\u2010301 is a new non\u2010pharmacological nasal spray that creates a protective gel\u2010like barrier on the nasal mucosa, preventing the contact with the allergens.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This randomized, open\u2010label, 3\u2010period crossover study assessed the efficacy and safety of AM\u2010301. The objective was to determine whether AM\u2010301 reduces allergic rhinitis (AR) symptoms in patients exposed to HDM allergens. Adults with confirmed Perennial Allergic Rhinitis (PAR; <jats:italic>n<\/jats:italic>\u00a0=\u00a037) were exposed to HDM allergen in a controlled Allergen Exposure Chamber before and during a treatment course of AM\u2010301 (in six different sequences) within 3\u00a0weeks (A: One spray AM\u2010301 per nostril\/B: Two sprays AM\u2010301 per nostril\/C: no treatment). For the primary efficacy analysis, data from the total nasal symptom score (TNSS) were pooled from treatment A\u00a0+\u00a0B (D) and analyzed with Analysis of Covariance Model. As secondary endpoints, single time points, visits and symptoms were analyzed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The primary endpoint (overall change in TNSS from baseline over all three visits) showed significant results (<jats:italic>p<\/jats:italic>\u00a0=\u00a00.0085). A comparable alleviation of all four symptoms (itchy nose, nasal congestion, runny nose, sneezing) by the protective layer started to emerge after 40\u00a0min and lasted up to 180\u00a0min (end of challenge). AM\u2010301 resulted to be safe and well\u2010tolerated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>AM\u2010301 significantly reduced HDM\u2010related allergic symptoms in a standardized allergen challenge. Protection was observed to last up to 180\u00a0min.<\/jats:p><\/jats:sec>","DOI":"10.1002\/clt2.12277","type":"journal-article","created":{"date-parts":[[2023,7,14]],"date-time":"2023-07-14T06:17:21Z","timestamp":1689315441000},"source":"Crossref","is-referenced-by-count":5,"title":["Barrier\u2010forming, drug\u2010free nasal spray reduces allergic symptoms induced by house dust mite allergen"],"prefix":"10.1002","volume":"13","author":[{"given":"Patricia","family":"Couroux","sequence":"first","affiliation":[{"name":"Inflamax Research DBA Cliantha Research  Mississauga Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicole","family":"Grosse","sequence":"additional","affiliation":[{"name":"Altamira Medica AG  Zug Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne Marie","family":"Salapatek","sequence":"additional","affiliation":[{"name":"Inflamax Research DBA Cliantha Research  Mississauga Ontario 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