Investigating how nasal IgE production affects allergy responses to birch pollen
Contribution of Local Nasal IgE Production to the Boost of Systemic Allergen-specific IgE Production Upon Nasal Allergen Contact - an Explorative Pilot Study
This study is testing how nasal IgE production affects allergy responses in people exposed to birch pollen to see if it can help us understand allergies better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT05042830 on ClinicalTrials.gov |
What this trial studies
This study aims to understand the role of nasal IgE production in boosting systemic allergen-specific IgE levels following exposure to birch pollen. It involves a randomized, placebo-controlled, double-blind design where 30 participants will be exposed to either birch pollen extract or a placebo. The study will closely monitor participants for up to four months to assess changes in IgE levels and allergic responses. The findings could provide insights into the mechanisms of allergic reactions and inform future therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates are individuals sensitized to birch pollen with moderate to severe allergic rhinitis.
Not a fit: Patients with acute, chronic, malignant, or general diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for individuals suffering from birch pollen allergies.
How similar studies have performed: While the specific approach of this study is novel, previous studies have shown that understanding IgE mechanisms can lead to advancements in allergy treatments.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Vienna, State of Vienna
- Medical University of Vienna — Vienna, State of Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Sven Schneider, MD — Medical University of Vienna
- Study coordinator: Sven Schneider, MD
- Email: sven.schneider@meduniwien.ac.at
- Phone: +4314040034380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.