Could a dissolved allergy tablet replace the old nasal test for birch pollen?
NCT ID NCT06085963
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This completed study tested whether a dissolved allergy tablet (Itulazax) can be used as a nasal spray to diagnose birch pollen allergy. 89 participants received either the dissolved tablet or a saltwater spray, and their nasal symptoms and airflow were measured. The goal was to see if this new method works as well as the old test, which is no longer available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dissolved Itulazax (birch pollen extract) tablet
- What this could lead to
- If successful, this could provide a new, easier-to-use nasal test to confirm birch pollen allergy and motivate patients for treatment.
- What could go wrong
- This is a small, completed feasibility study, not a treatment trial. The new test may not work as well as the old one, and results may not apply to all patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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89 people
The number who actually took part.
- Started
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Feb 2023
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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). Exclusion Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Karolinska University Hospital
Stockholm, 17176, Sweden
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Other studies related to the condition(s) this trial covers.