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This record was last updated May 7, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.
Record History
MinorChangedRegistry marked status Unknown (sponsor has not verified the record since Jun 2024); last known: Recruiting
NotablePrimary completion date: Jan 2025 to Jan 2026Site details revisedv5Show 1 more changeShow less
Site details revised
MinorRe-verified, no change to tracked fieldsv4
NotablePrimary completion date: Jan 2022 to Jan 2025Completion date: Sep 2022 to Sep 2026v3Show 1 more changeShow less
Completion date: Sep 2022 to Sep 2026
NotablePrimary endpoint revisedStart date changed from estimate of Oct 2021 to Nov 11, 2021 · Eligibility criteria revised · Study description expanded, about 3 words · 1 morev2Show 4 more changesShow less
Start date changed from estimate of Oct 2021 to Nov 11, 2021
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
IgE-associated allergies are consistently on the rise forming an enormous wellbeing concern and affecting about 25% of the population around the world, with main prevalence in developed nations. Birch pollen is one important allergen driving allergic conjunctivitis and rhinitis. The characteristics and location IgE producing cells in the nose and their contribution to the subsequent increase in allergen-specific IgE levels in the serum have so far poorly been investigated. Understanding these mechanisms is critical for the development of new therapeutic approaches and is thus the aim of the proposed study. Thus, the investigators plan to conduct a two-armed study of a randomized placebo-controlled double-blind nasal allergen provocation where 30 patients will be provoked with birch pollen extract (n=20) or placebo (n=10) out of the birch pollen season (October) and follow them closely for up to 4 months. Therefore, the objective of this study is to investigate the localization and characteristics of IgE producing cells in the nasal mucosa contributing to the allergen-induced boosts of specific serum IgE upon natural and controlled nasal allergen exposure.