Contribution of Nasal IgE Production to the Boost of Systemic Allergen-specific IgE Upon Nasal Allergen Contact

Recruiting now · Not applicable

Conditions studied: Allergy

In brief

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.

Key facts

Study ID: NCT05042830
Run by: Medical University of Vienna
People needed: 30
Starts: 2021-11-11
Expected to finish: 2026-09-01
Last updated by the study team: 2025-05-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Birch pollen sensitized subjects
Moderate to severe allergic rhinitis to birch pollen allergen for at least two seasons according to their medical history
Sensitization to Bet v 1 (Bet v 1 specific IgE: 3.5 kU/L or higher as specified by UniCAP-FEIA)
CD203c or CD63 upregulation upon challenge with Bet v 1 in flow cytometric basophil activation tests (≥20% upregulation of CD63 or CD203c upon Bet v 1 stimulation in comparison with unstimulated controls as measured by flow cytometry)
Willingness to follow the protocol.
Written informed consent
Standard healthcare insurance
Subjects should be available during the entire study period

You may not qualify if…

Evidence of acute, chronic, malignant or general diseases- assessed by asking the patient (e.g. Did you suffer or are you currently suffering from any malignant or generalised disease? Did you suffer or are you currently suffering from any chronic disease? Did you have any acute disease in the past two weeks?).
A History of anaphylaxis.
Utilization of leukotriene modifiers.
Utilization of long-acting antihistamines.
Chronic or intermittent use of oral, inhaled, intramuscular, intravenous, and potent topical corticosteroids.
Nasal polyps, history of chronic sinusitis or considerable deviation of the nasal septum
Rhinitis secondary to other causes.
Contra-indications to skin prick testing, for example, skin irritation in the test area and urticaria factitia.
Cardiovascular diseases or anti-hypertensive therapy and beta-blockers.
Any disruption of coagulation system through medication or known clotting disorders
Prophylactic aspirin therapy
Chronic use of additional medications that would affect assessment and the results of the study (e.g., tricyclic antidepressants that block both H1 and H2 receptors)
Pregnant or breastfeeding females.
Actual disability that would influence subject's ability to participate in the study.
History of mental illness, intellectual deficiency, drug or alcohol abuse
Active asthma requiring treatment
Birch Pollen allergen immunotherapy
Arranged travel outside the study region for a substantial portion of study period.

Where it is running

Medical University of Vienna — Vienna, State of Vienna, Austria (enrolling)

Full record on ClinicalTrials.gov

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