Actively Recruiting
Contribution of Nasal IgE Production to the Boost of Systemic Allergen-specific IgE Upon Nasal Allergen Contact
Led by Medical University of Vienna · Updated on 2025-05-07
30
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Contribution of Nasal IgE Production to the Boost of Systemic Allergen-specific IgE Upon Nasal Allergen Contact
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Birch pollen sensitized subjects
- Moderate to severe allergic rhinitis to birch pollen allergen for at least two seasons
- Sensitization to Bet v 1 with specific IgE of 3.5 kU/L or higher
- CD203c or CD63 upregulation upon Bet v 1 challenge in basophil activation tests (≥20% upregulation)
- Willingness to follow the protocol
- Written informed consent
- Standard healthcare insurance
- Availability during the entire study period
You will not qualify if you...
- Evidence of acute, chronic, malignant, or general diseases
- History of anaphylaxis
- Use of leukotriene modifiers
- Use of long-acting antihistamines
- Chronic or intermittent corticosteroid use (oral, inhaled, intramuscular, intravenous, topical)
- Nasal polyps, chronic sinusitis, or significant nasal septum deviation
- Rhinitis caused by other factors
- Contraindications to skin prick testing
- Cardiovascular diseases or use of beta-blockers or anti-hypertensive therapy
- Clotting disorders or use of coagulation-affecting medications
- Prophylactic aspirin therapy
- Use of medications affecting study assessment (e.g., tricyclic antidepressants)
- Pregnant or breastfeeding females
- Disabilities affecting study participation
- History of mental illness, intellectual deficiency, drug or alcohol abuse
- Active asthma requiring treatment
- Previous birch pollen allergen immunotherapy
- Planned travel outside the study region for much of the study period
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
Research Team
S
Sven Schneider, MD
CONTACT
J
Julia Eckl-Dorna, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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