Nasal Allergen Challenge Test as a Method to Detect Clinical Reactivity Against Birch Pollen (NCT06085963) | Clinical Trial Compass
CompletedNot Applicable
Nasal Allergen Challenge Test as a Method to Detect Clinical Reactivity Against Birch Pollen
Sweden89 participantsStarted 2023-02-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 conjunctivi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
TNSS
Timeframe: The symptoms are scored 5,15 and 30 minutes after provocation
2
PNIF
Timeframe: The symptoms are scored 5,15 and 30 minutes after provocation.