Allergic RhinitisAllergyAgeNCT06459219
Factors Determining Tolerance to Nasal Allergen Exposure With Advanced Age in a Subset of Birch Pollen Allergic Subjects
An observational study of Allergic Rhinitis and Allergic Conjunctivitis, run by Sven Schneider, MD at 1 site in Austria.
Trial summary
Nasal allergen study in patients aged 60+ with or without current respiratory allergy Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis, Allergic Conjunctivitis
- How many people
- 152 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2025to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged ≥ 60 years with or without current or former allergy
Who may be able to join
- 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):
- 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
- 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/
Who cannot join
- - 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Nasal allergen study in patients aged 60+ with or without current respiratory allergy
Read the detailed description
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.
- Conditions
- Allergic Rhinitis, Allergic Conjunctivitis
- Medical subject headings
- Rhinitis, Allergic, Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ongoing (symptoms min 3 years) | 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 | |
| Previous (no symptoms past 3 years) | 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 (never symptoms) | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Dec 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sven Schneider, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sven Schneider, MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459219
- Sponsor's protocol ID
- AllergyAge
- Acronym
- AllergyAge
- Status last verified
- May 2025
- First submitted
- 10 Jun 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Determining Tolerance to Nasal Allergen Exposure With Advanced Age in a Subset of Birch Pollen Allergic Subjects
- ClinicalTrials.gov ID
- NCT06459219
- Acronym / sponsor ID
- AllergyAge / AllergyAge
- Conditions
- Allergic Rhinitis, Allergic Conjunctivitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Sven Schneider, MDUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nasal allergen study in patients aged 60+ with or without current respiratory allergy
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ongoing (symptoms min 3 years) | – | –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 |
| Previous (no symptoms past 3 years) | – | –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 (never symptoms) | – | –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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥ 60 years with or without current or former allergy
Key inclusion criteria (8 listed)
- 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):
- 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
- 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/
Key exclusion criteria (16 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nasal IgG4
Time frame: 5 weeks
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis and Allergic Conjunctivitis, run by Sven Schneider, MD at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal IgG4 (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.