Birch-induced allergic rhinitis: Results of exposure during nasal allergen challenge, environmental chamber, and pollen season.
Allergic rhinitis
Birch allergy
Birch pollen
Environmental exposure chamber
Nasal allergen challenge
Journal
The World Allergy Organization journal
ISSN: 1939-4551
Titre abrégé: World Allergy Organ J
Pays: United States
ID NLM: 101481283
Informations de publication
Date de publication:
Jul 2023
Jul 2023
Historique:
received:
01
03
2023
revised:
22
06
2023
accepted:
28
06
2023
medline:
31
7
2023
pubmed:
31
7
2023
entrez:
31
7
2023
Statut:
epublish
Résumé
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. 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 (ΔTNSS) ≥ 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. The dose most commonly yielding positive TNSS during NAC was 175.2 ng/200 μL. Eighteen participants experienced ΔTNSS ≥5 during the last 2 h of the first exposure, whereas 21 had positive responses at all 4 exposures. Mean ΔTNSS was 1 with placebo versus 6 with birch. Exposures were reproducible, with no observed priming effect. Airborne Bet v 1 was 25 ng/m 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.
Sections du résumé
Background
UNASSIGNED
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
UNASSIGNED
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 (ΔTNSS) ≥ 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
UNASSIGNED
The dose most commonly yielding positive TNSS during NAC was 175.2 ng/200 μL. Eighteen participants experienced ΔTNSS ≥5 during the last 2 h of the first exposure, whereas 21 had positive responses at all 4 exposures. Mean ΔTNSS was 1 with placebo versus 6 with birch. Exposures were reproducible, with no observed priming effect. Airborne Bet v 1 was 25 ng/m
Conclusion
UNASSIGNED
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.
Identifiants
pubmed: 37520615
doi: 10.1016/j.waojou.2023.100801
pii: S1939-4551(23)00061-3
pmc: PMC10384658
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100801Informations de copyright
© 2023 The Authors.
Déclaration de conflit d'intérêts
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.
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