Contribution of Local Nasal IgE Production to the Boost of Systemic Allergen-specific IgE Production Upon Nasal Allergen Contact - an Explorative Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Biological, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Medical University of Vienna
RECRUITING
Vienna
Contact Information
Primary
Sven Schneider, MD
sven.schneider@meduniwien.ac.at
+4314040034380
Backup
Julia Eckl-Dorna, MD, PhD
julia.eckl-dorna@meduniwien.ac.at
+4314040034380
Time Frame
Start Date: 2021-11-11
Estimated Completion Date: 2026-09
Participants
Target number of participants: 30
Treatments
Active_comparator: Active group
Birch allergic subjects receiving birch pollen extract challenge
Placebo_comparator: Control group
Birch allergic subjects receiving saline
Sponsors
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov

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