ImmunotherapyNCT05621356
Monitoring Allergen Immunotherapy in Allergic Rhinitis
An observational study of Immunotherapy and Rhinitis, Allergic, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Allergic rhinitis (hay fever) can be treated successfully with allergen-specific immunotherapy (AIT) for 3-5 years. This relative expensive and prolonged treatment is not suitable for everyone and therefore it is important to predict who will benefit from this therapy early after the start of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunotherapy, Rhinitis, Allergic, Treatment Outcome
- What is being tested?
- A nasal fluid Basophil Activation Test (BAT)
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Oct 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Birch pollen allergic patients who are treated with Itulazax (birch pollen SLIT-tablet) and birch pollen allergic patients who are treated with immunosuppressive medication (control group).
Who may be able to join
- IgE-sensitized birch pollen allergy
- Start of Itulazax therapy or immunosuppressive therapy (nasal corticosteroid and/or antihistamine eye drops)
- Signed informed consent
Who cannot join
- Other underlying chronic conditions (immunological (autoimmune or immunodeficiency), oncological)
- Unstable uncontrolled asthma
- Smoking
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Rijnstate Hospital
Arnhem, 6815 AD
Janneke Ruinemans-Koerts, 0031 88 005 8888
About this study
Official title: Monitoring Allergen Immunotherapy in Allergic Rhinitis; is Nasal Fluid the Way to Precision Medicine?
Allergic rhinitis (hay fever) can be treated successfully with allergen-specific immunotherapy (AIT) for 3-5 years. This relative expensive and prolonged treatment is not suitable for everyone and therefore it is important to predict who will benefit from this therapy early after the start of treatment.
This project will investigate whether a BAT with nasal fluid can detect inhibition during immunotherapy in comparison with a BAT with blood.
Read the detailed description
Allergic rhinitis (hay fever) can be treated successfully with allergen-specific immunotherapy (AIT) for 3-5 years. This relative expensive and prolonged treatment is not suitable for everyone and therefore it is important to predict who will benefit from this therapy early after the start of treatment. Biomarkers, like Basophil Activation Test (BAT) and IgE-facilitated allergen binding (FAB), using nasal fluid instead of blood, probably better reflect therapy effect (inhibition of an IgE-mediated allergic reaction) as the nose is the main target organ for AIT in allergic rhinitis.
This project will investigate whether a BAT with nasal fluid can detect inhibition during immunotherapy in comparison with a BAT with blood. Nasal fluid and blood samples are collected at baseline and after 8 and 16 weeks of treatment. A nasal fluid inhibition BAT is developed and validated by comparison with a BAT using serum and an IgE-FAB assay.
15 adults with birch pollen allergy, who are treated with AIT (Itulazax birch pollen tablet) and 10 adults with birch pollen allergy, who are treated with immunosuppressive medication (control group) will be included in the study.
- Conditions
- Immunotherapy, Rhinitis, Allergic, Treatment Outcome
- Being tested
- A nasal fluid Basophil Activation Test (BAT)
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A nasal fluid Basophil Activation Test (BAT)Other
a BAT technique for monitoring the inhibitory effect of nasal fluid on basophil activation.
| Study group | Role | What they receive |
|---|---|---|
| allergen-specific immunotherapy (AIT) | Adults with birch pollen allergy, who are treated with allergen-specific immunotherapy (AIT) Receives: Other: A nasal fluid Basophil Activation Test (BAT) | |
| control | Adults with birch pollen allergy, who are treated with immunosuppressive medication Receives: Other: A nasal fluid Basophil Activation Test (BAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
BAT outcome nasal fluid
Measured: 8 weeks
BAT outcome nasal fluid
Measured: 16 weeks
BAT outcome serum
Measured: 8 weeks
BAT outcome serum
Measured: 16 weeks
Secondary outcomes (4)
IgG4/IgA-associated inhibitory activity in nasal fluid
Measured: 8 weeks
IgG4/IgA-associated inhibitory activity in nasal fluid
Measured: 16 weeks
IgG4/IgA-associated inhibitory activity in serum
Measured: 8 weeks
IgG4/IgA-associated inhibitory activity in serum
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start25 Oct 2022
- Primary completion23 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunotherapyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621356
- Sponsor's protocol ID
- 2021-1924
- Other IDs
- NL78278.091.21
- Status last verified
- Nov 2022
- First submitted
- 10 Nov 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Allergen Immunotherapy in Allergic Rhinitis; is Nasal Fluid the Way to Precision Medicine?
- ClinicalTrials.gov ID
- NCT05621356
- Acronym / sponsor ID
- 2021-1924
- Conditions
- Immunotherapy, Rhinitis, Allergic, Treatment Outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Wageningen University
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 23 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 18 Nov 2022 (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.
Allergic rhinitis (hay fever) can be treated successfully with allergen-specific immunotherapy (AIT) for 3-5 years. This relative expensive and prolonged treatment is not suitable for everyone and therefore it is important to predict who will benefit from this therapy early after the start of treatment.
This project will investigate whether a BAT with nasal fluid can detect inhibition during immunotherapy in comparison with a BAT with blood.
Detailed description
Allergic rhinitis (hay fever) can be treated successfully with allergen-specific immunotherapy (AIT) for 3-5 years. This relative expensive and prolonged treatment is not suitable for everyone and therefore it is important to predict who will benefit from this therapy early after the start of treatment. Biomarkers, like Basophil Activation Test (BAT) and IgE-facilitated allergen binding (FAB), using nasal fluid instead of blood, probably better reflect therapy effect (inhibition of an IgE-mediated allergic reaction) as the nose is the main target organ for AIT in allergic rhinitis.
This project will investigate whether a BAT with nasal fluid can detect inhibition during immunotherapy in comparison with a BAT with blood. Nasal fluid and blood samples are collected at baseline and after 8 and 16 weeks of treatment. A nasal fluid inhibition BAT is developed and validated by comparison with a BAT using serum and an IgE-FAB assay.
15 adults with birch pollen allergy, who are treated with AIT (Itulazax birch pollen tablet) and 10 adults with birch pollen allergy, who are treated with immunosuppressive medication (control group) will be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| allergen-specific immunotherapy (AIT) | – | Other: A nasal fluid Basophil Activation Test (BAT)Adults with birch pollen allergy, who are treated with allergen-specific immunotherapy (AIT) |
| control | – | Other: A nasal fluid Basophil Activation Test (BAT)Adults with birch pollen allergy, who are treated with immunosuppressive medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Birch pollen allergic patients who are treated with Itulazax (birch pollen SLIT-tablet) and birch pollen allergic patients who are treated with immunosuppressive medication (control group).
Key inclusion criteria (3 listed)
- IgE-sensitized birch pollen allergy
- Start of Itulazax therapy or immunosuppressive therapy (nasal corticosteroid and/or antihistamine eye drops)
- Signed informed consent
Key exclusion criteria (3 listed)
- Other underlying chronic conditions (immunological (autoimmune or immunodeficiency), oncological)
- Unstable uncontrolled asthma
- Smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A nasal fluid Basophil Activation Test (BAT)a BAT technique for monitoring the inhibitory effect of nasal fluid on basophil activation. | Other | allergen-specific immunotherapy (AIT), control |
Primary outcome
BAT outcome nasal fluid
Time frame: 8 weeks
BAT outcome nasal fluid
Time frame: 16 weeks
BAT outcome serum
Time frame: 8 weeks
BAT outcome serum
Time frame: 16 weeks
4 secondary outcomes
IgG4/IgA-associated inhibitory activity in nasal fluid
Time frame: 8 weeks
IgG4/IgA-associated inhibitory activity in nasal fluid
Time frame: 16 weeks
IgG4/IgA-associated inhibitory activity in serum
Time frame: 8 weeks
IgG4/IgA-associated inhibitory activity in serum
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
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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. This study is not recruiting at the moment.
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 Immunotherapy and Rhinitis, Allergic, run by Rijnstate Hospital at 1 site in Netherlands.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Nov 2022. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janneke Ruinemans-Koerts (0031 88 005 8888, j.ruinemans-koerts@rijnstate.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BAT outcome nasal fluid (time frame: 8 weeks). The study lists 4 primary outcomes in all. 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 18 Nov 2022.