Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID05042830

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

Led by Medical University of Vienna · Updated on 2025-05-07

30

Participants Needed

1

Research Sites

34 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are investigating the role of IgE-producing cells in the nasal mucosa and their contribution to increasing allergen-specific IgE levels in the blood after nasal allergen exposure. This study focuses on birch pollen allergy, which affects many people and causes symptoms like allergic conjunctivitis and rhinitis. The research aims to better understand how local nasal IgE production affects systemic allergic responses, an area not well understood but important for developing new treatments. The study involves a randomized, double-blind, placebo-controlled design with two groups: one receiving birch pollen extract nasal challenge and the other receiving a saline placebo outside the pollen season. Participants will be closely followed for up to four months. The team will use advanced techniques such as flow cytometry and confocal microscopy to identify and study IgE-producing cells in blood and nasal biopsies. Additional procedures include nasal specimen collection, mucosal RNA sampling, skin prick testing, and nasal allergen challenge with symptom management as needed. Participants will undergo various assessments including blood sampling, nasal biopsies, and skin prick tests to track allergic responses and IgE cell levels over time. Nasal airflow measurements and pregnancy tests in females are part of the monitoring process. The main outcome measured is the amount of IgE-producing cells over three years. The study requires regular visits and close follow-up to capture changes in IgE production and allergic inflammation, with total participation lasting up to four months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

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 (≥20%) in basophil activation tests upon Bet v 1 challenge
  • Willingness to follow the study protocol
  • Written informed consent
  • Standard healthcare insurance
  • Availability during the entire study period
Not Eligible

You will not qualify if you...

  • Acute, chronic, malignant, or general diseases
  • History of anaphylaxis
  • Use of leukotriene modifiers or long-acting antihistamines
  • Chronic or intermittent use of corticosteroids
  • Nasal polyps, chronic sinusitis, or significant nasal septum deviation
  • Rhinitis caused by other reasons
  • Contraindications to skin prick testing
  • Cardiovascular diseases or use of beta-blockers
  • Blood clotting disorders or related medications
  • Prophylactic aspirin therapy
  • Use of medications affecting study assessments, e.g., tricyclic antidepressants
  • Pregnant or breastfeeding females
  • Disabilities affecting study participation
  • History of mental illness, intellectual deficiency, or substance abuse
  • Active asthma requiring treatment
  • Birch pollen allergen immunotherapy
  • Planned travel outside the study region during most of the study period

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Intranasal Allergen Challenge

Duration - Single day

Participants undergo a controlled intranasal challenge with birch pollen extract or saline to study local and systemic IgE production.

1 visit (in-person)

Sample Collection and Analysis

Duration - Several days around challenge

Participants provide blood samples, nasal biopsies, mucosal RNA samples, and nasal specimen collection for flow cytometry, confocal microscopy, and RNA sequencing to identify IgE producing cells.

1 to 3 visits depending on procedures

Long-term Monitoring

Duration - Up to 3 years

Participants' IgE producing cells and allergen-specific IgE levels are monitored over an extended period to understand kinetics and systemic boosting.

Visits scheduled periodically over 3 years

Trial Site Locations

Total: 1 location

1

Medical University of Vienna

Vienna, State of Vienna, Austria, 1090

Actively Recruiting

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Research Team

S

Sven Schneider, MD

J

Julia Eckl-Dorna, MD, PhD

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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Published Research Related To This Trial

Effects of nasal corticosteroids on boosts of systemic allergen-specific IgE production induced by nasal allergen exposure.

Cornelia Egger, Christian Lupinek, Robin Ristl...

https://pubmed.ncbi.nlm.nih.gov/25705889

Intranasal administration of allergen increases specific IgE whereas intranasal omalizumab does not increase serum IgE levels-A pilot study.

J Eckl-Dorna, R Fröschl, C Lupinek...

https://pubmed.ncbi.nlm.nih.gov/29083477

Allergen-specific IgE levels and the ability of IgE-allergen complexes to cross-link determine the extent of CD23-mediated T-cell activation.

Sergio Villazala-Merino, Azahara Rodriguez-Dominguez, Victoria Stanek...

https://pubmed.ncbi.nlm.nih.gov/31775017