Allergic Rhinitis Due to PollenNACNCT06085963
Nasal Allergen Challenge Test as a Method to Detect Clinical Reactivity Against Birch Pollen
A study testing ITULAZAX 12 SQ-Bet and Nacl in people with Allergic Rhinitis Due to Pollen, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Clinical efficacy and tolerability for allergen specific immunotherapy (AIT) with Itulazax (birch pollen extract tablet) is well established. Allergen challenges are used by clinicians to confirm correct diagnosis and by researchers to evaluate the efficacy of different interventions, eg. AIT. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis Due to Pollen
- What is being tested?
- ITULAZAX 12 SQ-Bet and Nacl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2023to 31 Dec 2024
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent obtained before any trial related assessments are performed
- Male or female aged 18-65 years at the time of consent
- A female subject of child-bearing potential must have a negative pregnancy test and be willing to practise appropriate highly effective birth control methods. The definition of a female patient of childbearing potential is a nonmenopausal female who has not had a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure.
- The subject must be willing and able to comply with the trial protocol
- Birch pollen allergy group: A documented clinically relevant history of moderate to severe persistent birch pollen allergy symptoms since at least 2 years with troublesome symptoms despite the use of symptomatic medication with or without asthma; positive SPT(skin prick testing) response (wheal diameter ≥3 mm) to birch pollen (birch) and positive specific IgE (immunoglobulin E) to birch (≥ IgE CAP(quantitative test that measures the overall quantity of circulating IgE in the blood) class 2; ≥0.70 kU/L) at screening.
- Non-allergic control group: A documented negative clinical history for allergic rhinitis, negative SPT response (wheal diameter <3 mm) and negative sIgE (IgE CAP class 0) to birch pollen (birch), grasses, house dust mite, cat, horse, dog, ragweed, mugwort and mould (Alternaria alternata).
Who cannot join
- A subject in the birch pollen allergy group with rhinitis and/or conjunctivitis caused by animal hair and dander to which the subject is regularly exposed is not eligible for the trial. In terms of seasonal and perennial allergens like moulds etc. the subject can be sensitised to these allergens but is not eligible for the trial if the subject has symptoms induced by these allergens during the trial period.
- Patients who have experienced a severe asthma exacerbation within the last 3 months.
- Reduced lung function (in adults: FEV1 (Forced Expiratory Volume 1 sec) < 70% of predicted value after adequate pharmacologic treatment).
- SLIT (sublingual immunotherapy) treatment with birch pollen for more than 1 month within the last 5 years. In addition, any SLIT treatment with birch pollen within the previous 12 months.
- SCIT (subcutaneous immunotherapy) treatment with birch pollen reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with birch pollen within the previous 12 months.
- Ongoing treatment with any allergy immunotherapy product
Show all 19Show fewer
- Has any nasal oropharyngeal condition that might mimic birch pollen allergy symptoms (e.g. strong septal deviation, nasal polyps, a history of paranasal sinus surgery or surgery of nasal turbinate's; choanal atresia, hypertrophy of pharyngeal tonsil, naso/oropharyngeal tumours, hypertrophy of palatial tonsils). For exclusion both sided nasal endoscopy including endoscopy of the epipharynx is required.
- Any general condition that might induce birch pollen allergy symptoms (hypothyroidism, pregnancy).
- Any pharmacotherapy that might induce birch pollen symptoms (e.g. treatment with antihypertensive drugs, treatment with cholinergic acting drugs like antidepressants).
- History of any other (allergic) rhinitis symptoms than to birch pollen during the whole study period for subjects in the birch pollen allergy group.
- A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema that in the opinion of the investigator may constitute an increased safety concern.
- Any clinically relevant chronic disease incl. malignancy that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subject.
- Active or poorly controlled autoimmune diseases, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic diseases with current disease relevance.
- Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit.
- ·-Treatment with medications with potential impact on NAC (e.g. treatment with anti-IgE or anti IL-5 (interleukin 5) drugs within 130 days/5 half-lives of the drug (which ever longest) or treatment with antidepressant or antipsychotic medications with antihistaminic effect).
- Current participation in other clinical trials and or use of an investigational drug within 30 days/5 half-lives of the drug, which ever the longest, prior to screening.
- A history of allergy, hypersensitivity or intolerance to the IMP (investigation medicinal product) (except birch pollen).
- Smoking / significant history of smoking.
- A history of alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Clinical efficacy and tolerability for allergen specific immunotherapy (AIT) with Itulazax (birch pollen extract tablet) is well established.
Allergen challenges are used by clinicians to confirm correct diagnosis and by researchers to evaluate the efficacy of different interventions, eg. AIT. The challenge is performed by using a specific controlled administration schedule of an allergen product in the shock organ (nose, eye, or airway) and then monitor the result. Nasal Allergen Challenge (NAC) is the most common allergen challenge used.
Read more
Aquagen SQ (birch pollen extract) has since decades been golden standard for this purpose, but production of this product ended 2019. Clinicians as well as researchers are now in need for an alternative product.
To evaluate a new method for NAC would be of value from a clinical- and research perspective. From a Nordic perspective a NAC study with dissolved Itulazax would be of special interest since birch allergy is a dominant allergen in the region. In a recently published article it was shown that dissolved Grazax and Aquagen Phleum pratense gave comparable result used in grass allergic patients. Therefore, it seems reasonable to assume that the same method could be used with dissolved Itulazax.
The aim of this clinical trial is to evaluate the feasibility of nasal allergen challenge tests with dissolved Itulazax tablets. The main benefit of this proposal is that the allergen composition of the provocation test product is the same as the final product to be treated with. This is likely to increase the treatment motivation of the patient. In addition, the dissolving process is easier for the physician compared to the dissolving of the previously used Aquagen.
Read the detailed description
The objective of the trial is to establish a method for Nasal Allergen Challenge (NAC) with dissolved Itulazax.
This trial is an open-label, national, one-centre trial comparing the results of NAC applied by solutions of dilutions of dissolved Itulazax tablets with the clinical diagnosis of birch pollen allergy by an experienced physician.
To ensure negative reactivity to the excipients of the tablet and the nasal provocation itself a non-atopic control group of 20 subjects will be challenged with both a dissolved placebo-tablet and 0.9% saline solution. This provocation will be performed as a one-sided blinded challenge which will demonstrate that the NAC is truly negative.
Thereafter 70 patients will initially receive a NAC with 0,9% saline solution to ensure negative reactivity to the challenge as method. If negative after 30 minutes NAC will continue with one puff (1x0.1 ml) dissolved Itulazax (1 SQ-Bet/ml) in each nostril. Total nasal symptom scores (TNSS, 0-12) and peak nasal inspiratory flow (PNIF) will be recorded before NAC and then at 5, 15 and 30 minutes.
- Conditions
- Allergic Rhinitis Due to Pollen
- Being tested
- ITULAZAX 12 SQ-Bet, Placebo tablet, Nacl
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITULAZAX 12 SQ-BetDrug
Active ingredients: Birch (Betula verrucosa) extracts Dosage form: Oral lyophilisate (referred to as allergy immunotherapy tablet in text) Dose/strength: 12 SQ-Bet Excipients: Gelatine (fish source), mannitol and sodium hydroxide
Placebo tabletDrug
Active ingredients: None Dosage form: Oral lyophilisate (referred to as allergy immunotherapy tablet in text) Excipients: Gelatine (fish source), mannitol and sodium hydroxide
NaclDrug
Sodium chloride solution 9mg/ml
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | 20 subjects will be challenged with both a dissolved placebo-tablet and 0.9% saline solution. This provocation will be performed as a one-sided blinded challenge which will demonstrate that the NAC is truly negative.
Subjects will be randomized to dissolved placebo-tablet or saline solution in a cross over design. 10 subjects will start with dissolved placebo-tablet and 10 will start with 0.9% saline solution. After 30 minutes the subjects will switch to receive a challenge with the other solution. This will ensure negative reactivity to the excipients and challenge as a method. The placebo solution will be prepared the same as way as the active ITULAZAX® stock solutio Receives: Drug: Placebo tablet; Drug: Nacl |
| Birch group | Active comparator | NAC will be applied to 70 patients with birch pollen allergy. Subjects will initially receive a NAC with 0,9% saline solution to ensure negative reactivity to the challenge as method. If negative after 30 minutes NAC will continue with one puff (1x0.1 ml) dissolved ITULAZAX® (1 SQ-Bet/ml) in each nostril. Receives: Drug: ITULAZAX 12 SQ-Bet; Drug: Nacl |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNSS
0,1 x ml of dissolved Itulazax or NaCl will be sprayed into each nostril. The change from baseline (TNSS before provocation) in Total Nasal Symptom Score (TNSS) will be measured 5,15 and 30 minutes after negative (NaCl) and positive provocation (Itulazax). Subjective measures will be made by a Total Nasal Symptom Score (TNSS) on a 0-12 Likert scale. Increase of ≥5 points indicates clearly positive test. Increase of ≥3 points indicates moderately positive test
Measured: The symptoms are scored 5,15 and 30 minutes after provocation
PNIF
0,1 x ml of dissolved Itulazax or NaCl will be sprayed into each nostril. Peak nasal inspiratory flow (PNIF) wil be meaused with a PNIF Meter. The change from baseline (PNIF before provocation) in Peak Nasal Inspiratory Flow (PNIF) will be measured 5,15 and 30 minutes after negative (NaCl) and positive provocation (Itulazax). Objective measures will be an assessment of the Peak Nasal Inspiratory Flow (PNIF). Flow decrease of ≥40% indicates clearly positive test. Flow decrease of ≥20% indicates moderately positive test.
Measured: The symptoms are scored 5,15 and 30 minutes after provocation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 Feb 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis Due to PollenStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 20 non-atopic controls will be randomized to dissolved placebo-tablet or saline solution in a cross over design. . This will be performed in a one side blinded challenge where 10 subjects will start with placebo-tablet dissolved in 0,9% saline solution and 10 will start with 0,9% saline solution only. After 30 minutes subjects will receive the other solution. Thereafter 70 patients will initially receive a NAC with 0,9% saline solution to ensure negative reactivity to the challenge as method. If negative after 30 minutes NAC will continue with one puff (1x0.1 ml) dissolved ITULAZAX® (1 SQ-Bet/ml) in each nostril.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Olaf Cardell, Karolinska Institutet
- Investigators
- Lars-Olaf Cardell, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085963
- Sponsor's protocol ID
- EudraCT: 2021-004632-29
- Other IDs
- K 2023-7697
- Acronym
- NAC
- Status last verified
- Sep 2025
- First submitted
- 27 Sep 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Allergen Challenge Test as a Method to Detect Clinical Reactivity Against Birch Pollen
- ClinicalTrials.gov ID
- NCT06085963
- Acronym / sponsor ID
- NAC / EudraCT: 2021-004632-29
- Conditions
- Allergic Rhinitis Due to Pollen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 17 Oct 2023 (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.
Clinical efficacy and tolerability for allergen specific immunotherapy (AIT) with Itulazax (birch pollen extract tablet) is well established.
Allergen challenges are used by clinicians to confirm correct diagnosis and by researchers to evaluate the efficacy of different interventions, eg. AIT. The challenge is performed by using a specific controlled administration schedule of an allergen product in the shock organ (nose, eye, or airway) and then monitor the result. Nasal Allergen Challenge (NAC) is the most common allergen challenge used.
Aquagen SQ (birch pollen extract) has since decades been golden standard for this purpose, but production of this product ended 2019. Clinicians as well as researchers are now in need for an alternative product.
To evaluate a new method for NAC would be of value from a clinical- and research perspective. From a Nordic perspective a NAC study with dissolved Itulazax would be of special interest since birch allergy is a dominant allergen in the region. In a recently published article it was shown that dissolved Grazax and Aquagen Phleum pratense gave comparable result used in grass allergic patients. Therefore, it seems reasonable to assume that the same method could be used with dissolved Itulazax.
The aim of this clinical trial is to evaluate the feasibility of nasal allergen challenge tests with dissolved Itulazax tablets. The main benefit of this proposal is that the allergen composition of the provocation test product is the same as the final product to be treated with. This is likely to increase the treatment motivation of the patient. In addition, the dissolving process is easier for the physician compared to the dissolving of the previously used Aquagen.
Detailed description
The objective of the trial is to establish a method for Nasal Allergen Challenge (NAC) with dissolved Itulazax.
This trial is an open-label, national, one-centre trial comparing the results of NAC applied by solutions of dilutions of dissolved Itulazax tablets with the clinical diagnosis of birch pollen allergy by an experienced physician.
To ensure negative reactivity to the excipients of the tablet and the nasal provocation itself a non-atopic control group of 20 subjects will be challenged with both a dissolved placebo-tablet and 0.9% saline solution. This provocation will be performed as a one-sided blinded challenge which will demonstrate that the NAC is truly negative.
Thereafter 70 patients will initially receive a NAC with 0,9% saline solution to ensure negative reactivity to the challenge as method. If negative after 30 minutes NAC will continue with one puff (1x0.1 ml) dissolved Itulazax (1 SQ-Bet/ml) in each nostril. Total nasal symptom scores (TNSS, 0-12) and peak nasal inspiratory flow (PNIF) will be recorded before NAC and then at 5, 15 and 30 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 20 non-atopic controls will be randomized to dissolved placebo-tablet or saline solution in a cross over design. . This will be performed in a one side blinded challenge where 10 subjects will start with placebo-tablet dissolved in 0,9% saline solution and 10 will start with 0,9% saline solution only. After 30 minutes subjects will receive the other solution. Thereafter 70 patients will initially receive a NAC with 0,9% saline solution to ensure negative reactivity to the challenge as method. If negative after 30 minutes NAC will continue with one puff (1x0.1 ml) dissolved ITULAZAX® (1 SQ-Bet/ml) in each nostril.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Placebo tablet, Drug: Nacl20 subjects will be challenged with both a dissolved placebo-tablet and 0.9% saline solution. This provocation will be performed as a one-sided blinded challenge which will demonstrate that the NAC is truly negative. Subjects will be randomized to dissolved placebo-tablet or saline solution in a cross over design. 10 subjects will start with dissolved placebo-tablet and 10 will start with 0.9% saline solution. After 30 minutes the subjects will switch to receive a challenge with the other solution. This will ensure negative reactivity to the excipients and challenge as a method. The placebo solution will be prepared the same as way as the active ITULAZAX® stock solutio |
| Birch group | Active comparator | Drug: ITULAZAX 12 SQ-Bet, Drug: NaclNAC will be applied to 70 patients with birch pollen allergy. Subjects will initially receive a NAC with 0,9% saline solution to ensure negative reactivity to the challenge as method. If negative after 30 minutes NAC will continue with one puff (1x0.1 ml) dissolved ITULAZAX® (1 SQ-Bet/ml) in each nostril. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent obtained before any trial related assessments are performed
- Male or female aged 18-65 years at the time of consent
- A female subject of child-bearing potential must have a negative pregnancy test and be willing to practise appropriate highly effective birth control methods. The definition of a female patient of childbearing potential is a nonmenopausal female who has not had a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure.
- The subject must be willing and able to comply with the trial protocol
- Birch pollen allergy group: A documented clinically relevant history of moderate to severe persistent birch pollen allergy symptoms since at least 2 years with troublesome symptoms despite the use of symptomatic medication with or without asthma; positive SPT(skin prick testing) response (wheal diameter ≥3 mm) to birch pollen (birch) and positive specific IgE (immunoglobulin E) to birch (≥ IgE CAP(quantitative test that measures the overall quantity of circulating IgE in the blood) class 2; ≥0.70 kU/L) at screening.
Key exclusion criteria (19 listed)
- A subject in the birch pollen allergy group with rhinitis and/or conjunctivitis caused by animal hair and dander to which the subject is regularly exposed is not eligible for the trial. In terms of seasonal and perennial allergens like moulds etc. the subject can be sensitised to these allergens but is not eligible for the trial if the subject has symptoms induced by these allergens during the trial period.
- Patients who have experienced a severe asthma exacerbation within the last 3 months.
- Reduced lung function (in adults: FEV1 (Forced Expiratory Volume 1 sec) < 70% of predicted value after adequate pharmacologic treatment).
- SLIT (sublingual immunotherapy) treatment with birch pollen for more than 1 month within the last 5 years. In addition, any SLIT treatment with birch pollen within the previous 12 months.
- SCIT (subcutaneous immunotherapy) treatment with birch pollen reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with birch pollen within the previous 12 months.
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 |
|---|---|---|
| ITULAZAX 12 SQ-BetActive ingredients: Birch (Betula verrucosa) extracts Dosage form: Oral lyophilisate (referred to as allergy immunotherapy tablet in text) Dose/strength: 12 SQ-Bet Excipients: Gelatine (fish source), mannitol and sodium hydroxide | Drug | Birch group |
| Placebo tabletActive ingredients: None Dosage form: Oral lyophilisate (referred to as allergy immunotherapy tablet in text) Excipients: Gelatine (fish source), mannitol and sodium hydroxide | Drug | Control group |
| NaclSodium chloride solution 9mg/ml | Drug | Birch group, Control group |
Primary outcome
TNSS
Time frame: The symptoms are scored 5,15 and 30 minutes after provocation
0,1 x ml of dissolved Itulazax or NaCl will be sprayed into each nostril. The change from baseline (TNSS before provocation) in Total Nasal Symptom Score (TNSS) will be measured 5,15 and 30 minutes after negative (NaCl) and positive provocation (Itulazax). Subjective measures will be made by a Total Nasal Symptom Score (TNSS) on a 0-12 Likert scale. Increase of ≥5 points indicates clearly positive test. Increase of ≥3 points indicates moderately positive test
PNIF
Time frame: The symptoms are scored 5,15 and 30 minutes after provocation.
0,1 x ml of dissolved Itulazax or NaCl will be sprayed into each nostril. Peak nasal inspiratory flow (PNIF) wil be meaused with a PNIF Meter. The change from baseline (PNIF before provocation) in Peak Nasal Inspiratory Flow (PNIF) will be measured 5,15 and 30 minutes after negative (NaCl) and positive provocation (Itulazax). Objective measures will be an assessment of the Peak Nasal Inspiratory Flow (PNIF). Flow decrease of ≥40% indicates clearly positive test. Flow decrease of ≥20% indicates moderately positive test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Lars-Olaf Cardell, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ITULAZAX 12 SQ-Bet and Nacl in people with Allergic Rhinitis Due to Pollen, run by Karolinska Institutet at 1 site in Sweden.
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 6 inclusion and 19 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: finished, as of the sponsor's last update on 17 Sep 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
TNSS (time frame: The symptoms are scored 5,15 and 30 minutes after provocation). The study lists 2 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 17 Sep 2025.