Factors Determining Tolerance to Nasal Allergen Exposure With Advanced Age in a Subset of Birch Pollen Allergic Subjects

Launched by SVEN SCHNEIDER, MD · Jun 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking into how older adults (aged 60 and above) respond to exposure to birch pollen, a common trigger for allergies. The study focuses on three groups of participants: those who currently have a birch pollen allergy, those who had it in the past but have not experienced symptoms recently, and those who have never had this allergy. By understanding how tolerance to allergens changes with age, researchers hope to improve management strategies for people suffering from allergic rhinitis and conjunctivitis.

To be eligible for this study, participants must be at least 60 years old and willing to commit to the study requirements. They should also have a history related to birch pollen allergies or have never experienced such allergies at all. During the study, participants will undergo tests to assess their allergic responses and receive care as outlined by the study protocol. It's important to note that certain health conditions or medications may exclude individuals from participating. If you're interested in learning more or think you might qualify, please reach out to the study team once recruitment begins.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • General inclusion criteria Age ≥ 60 years Willingness to participate in the study and to follow the protocol Written informed consent Standard healthcare insurance Subjects should be available during the entire study period
• * Patient group specific inclusion criteria (n=38 per group):
• 1. Group 1 (current allergy):
• • Ongoing intermittent allergic rhinoconjunctivitis to birch pollen with moderate to severe symptoms according to ARIA guidelines for at least 10 years Positive Skin prick test (SPT) to birch pollen and/or Bet v 1-specific IgE ≥0.35kUA/L as measured by ImmunoCAP
• 2. Group 2 (former allergy):
• • History of intermittent allergic rhinoconjunctivitis to birch pollen ongoing with moderate to severe symptoms according ARIA guidelines for at least ten years (verified by at least one medical record including SPT results), but no symptoms for at least the three past consecutive seasons Positive or negative SPT to birch pollen and Bet v 1-specific IgE ≤ or ≥0.35kUA/L as measured by ImmunoCAP
• 3. Group 3 (never allergy):
• • No history of and no ongoing allergic rhinoconjunctivitis to birch pollen Negative SPT to birch pollen and Bet v 1-specific IgE ≤ 0.35kUA/
• Exclusion Criteria:
• • - Evidence of acute, chronic, malignant or general diseases-assessed by asking the patient
• • A History of anaphylaxis
• • Utilization of leukotriene modifiers or long-acting antihistamines
• • Chronic or intermittent use of oral, inhaled, intramuscular or intravenous 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 facticia
• • Cardiovascular diseases requiring treatment with anti-hypertensive medication or beta-blockers
• • Known clotting disorders
• • 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
• • Allergen immunotherapy within the last 5 years to any allergen
• • Current and former smokers who stopped smoking \<1 year ago