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

Launched by MEDICAL UNIVERSITY OF VIENNA · Sep 3, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how the immune system reacts to birch pollen, which is a common allergen that can cause symptoms like sneezing and itching in people with allergies. Specifically, researchers want to learn about certain cells in the nose that produce a type of antibody called IgE. Understanding how these cells work may help develop better treatments for allergies in the future. The trial will involve 30 participants who have a known allergy to birch pollen. They will be divided into two groups: one group will receive birch pollen extract and the other will get a placebo, which looks like the real treatment but has no active ingredients. Participants will be monitored for up to four months after the treatment.

To be eligible for this study, participants need to be aged between 6 and 74 and have been diagnosed with moderate to severe allergic rhinitis due to birch pollen for at least two seasons. They should also have a specific level of IgE in their blood related to birch pollen. Those who have certain health conditions, such as asthma, or who are taking specific medications, may not be eligible. If you decide to participate, you will be asked to follow the study guidelines and provide written consent. This research could be important for improving how allergies are treated in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.