PMID- 37520615 OWN - NLM STAT- Publisher LR - 20230801 IS - 1939-4551 (Print) IS - 1939-4551 (Electronic) IS - 1939-4551 (Linking) VI - 16 IP - 7 DP - 2023 Jul TI - Birch-induced allergic rhinitis: Results of exposure during nasal allergen challenge, environmental chamber, and pollen season. PG - 100801 LID - 10.1016/j.waojou.2023.100801 [doi] LID - 100801 AB - BACKGROUND: Pollen variation can affect field study data quality. Nasal allergen challenge (NAC) is considered the gold standard for evaluating allergic rhinitis, while environmental exposure chambers (EECs) are mainly used in phase 2 drug development studies. We aimed to study birch-induced allergic rhinitis under 3 different conditions. METHODS: This study included 30 participants allergic to birch pollen, based on birch skin prick test, specific immunoglobulin E (IgE), and positive NAC. Participants were exposed to placebo twice, followed by 2 consecutive 4-h birch airborne exposures, repeated on 2 occasions to evaluate reproducibility and priming effect. Nasal response was defined as total corrected nasal symptom score (DeltaTNSS) >/= 5 during NAC and EEC. The primary end-point was to measure TNSS during the last 2 h of first allergen exposure. TNSS was also analyzed during natural exposure. RESULTS: The dose most commonly yielding positive TNSS during NAC was 175.2 ng/200 muL. Eighteen participants experienced DeltaTNSS >/=5 during the last 2 h of the first exposure, whereas 21 had positive responses at all 4 exposures. Mean DeltaTNSS was 1 with placebo versus 6 with birch. Exposures were reproducible, with no observed priming effect. Airborne Bet v 1 was 25 ng/m(3), while the pollen measurement was 279/m(3) during pollen season. TNSS reached 5 in 67.9% of participants during peak pollen season. CONCLUSION: EEC outcomes were similar to those obtained with NAC and natural exposure, suggesting the usefulness of EEC in allergic rhinitis studies. The primary end-point was reached, as 60% of participants experienced nasal responses. CI - (c) 2023 The Authors. FAU - Gherasim, Alina AU - Gherasim A AD - ALYATEC Environmental Exposure Chamber, 1 place de l'Hopital, Strasbourg, France. FAU - Dietsch, Frank AU - Dietsch F AD - ALYATEC Environmental Exposure Chamber, 1 place de l'Hopital, Strasbourg, France. FAU - Beck, Marine AU - Beck M AD - ALYATEC Environmental Exposure Chamber, 1 place de l'Hopital, Strasbourg, France. FAU - Domis, Nathalie AU - Domis N AD - ALYATEC Environmental Exposure Chamber, 1 place de l'Hopital, Strasbourg, France. FAU - de Blay, Frederic AU - de Blay F AD - ALYATEC Environmental Exposure Chamber, 1 place de l'Hopital, Strasbourg, France. AD - Chest Diseases Department, Strasbourg University Hospital, Strasbourg, France. AD - Federation of Translational Medicine EA 3070, University of Strasbourg, Strasbourg, France. LA - eng PT - Journal Article DEP - 20230715 PL - United States TA - World Allergy Organ J JT - The World Allergy Organization journal JID - 101481283 PMC - PMC10384658 OTO - NOTNLM OT - Allergic rhinitis OT - Birch allergy OT - Birch pollen OT - Environmental exposure chamber OT - Nasal allergen challenge COIS- Alina Gherasim, Frank Dietsch, and Marine Beck are ALYATEC employees. Nathalie Domis is an ALYATEC co-founder and employee. FdB is the medical expert, co-founder, and shareholder of ALYATEC. Frederic de Blay reports grants from ASTRAZENECA, CHIESI, GSK, REGENERON, NOVARTIS, and STALLERGENES GREER, and personal fees from ALK ABELLO, ASTRAZENECA, CHIESI, MENARINI, NOVARTIS, and STALLERGENES GREER. EDAT- 2023/07/31 06:43 MHDA- 2023/07/31 06:43 PMCR- 2023/07/15 CRDT- 2023/07/31 04:54 PHST- 2023/03/01 00:00 [received] PHST- 2023/06/22 00:00 [revised] PHST- 2023/06/28 00:00 [accepted] PHST- 2023/07/31 06:43 [medline] PHST- 2023/07/31 06:43 [pubmed] PHST- 2023/07/31 04:54 [entrez] PHST- 2023/07/15 00:00 [pmc-release] AID - S1939-4551(23)00061-3 [pii] AID - 100801 [pii] AID - 10.1016/j.waojou.2023.100801 [doi] PST - epublish SO - World Allergy Organ J. 2023 Jul 15;16(7):100801. doi: 10.1016/j.waojou.2023.100801. eCollection 2023 Jul.