An observational study in Allergic Rhinitis and Allergic Conjunctivitis, sponsored by Sven Schneider, MD. Not yet recruiting at 1 site in Austria. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Sven Schneider, MD · Observational
Nasal allergen study in patients aged 60+ with or without current respiratory allergy
Allergic rhinoconjunctivitis (AR) represents a major health burden affecting an estimated 1.4 billion people globally. It is characterized by inflammation of the nasal mucosa and conjunctiva in response to exposure to airborne allergens (e.g. pollen, dust mites). Interestingly, with advanced age, prevalence of AR decreases suggesting that a subset of allergic patients is able to develop tolerance towards allergens resulting in absence of symptoms. Understanding this mechanism governing natural tolerance development in the context of allergy is critical for the development of new therapeutic approaches and thus the aim of the proposed study. To address this question, the investigators plan to conduct a nasal allergen challenge study in patients aged 60+ who (1) are currently suffering from birch pollen allergy, (2) have a history of birch pollen allergy but absence of symptoms for at least three seasons and (3) never suffered from birch pollen allergy. After signing informed consent and fulfilling selection criteria, 38 patients per group will be intranasally challenged with birch pollen extract outside of the birch pollen season (October) and followed closely for up to 10 weeks to assess clinical parameters, cytokines, allergen-specific Immunoglobulin (Ig) levels as well as inflammatory cell subsets under controlled pollen exposure. In summary, this study will yield important information on the mechanisms underlying natural tolerance development in respiratory allergy with advanced age.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's planned enrollment of 152 is above the median of 120 across 143 observational studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →This is the only study on the registry with Sven Schneider, MD as lead sponsor.
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Patients aged ≥ 60 years with or without current or former allergy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient group specific inclusion criteria (n=38 per group):
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
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
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 ≥60 y
History of intermittent allergic rhinoconjunctivitis to birch pollen ongoing with moderate to severe symptoms according ARIA guidelines26 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 ≥60 y
No history of and no ongoing allergic rhinoconjunctivitis to birch pollen Negative SPT to birch pollen and Bet v 1-specific IgE ≤ 0.35kUA/L ≥60 y
Nasal IgG4
To demonstrate that Bet v 1-specific nasal IgG4 responses 5 weeks after controlled nasal birch pollen provocation are significantly higher in subjects aged ≥60y without ongoing respiratory allergic symptoms with a history of allergy (group1) as compared to age-matched subjects currently suffering from allergic rhinoconjunctivitis (group 2).
Time frame: 5 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2025; primary completion for Oct 2027, 22 months later.
Of 36 non-industry observational studies under Rhinitis, Allergic, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's planned 22 months is above that.
Counting every sponsor, half of 49 studies reached it within 21 months; a quarter within 12 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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