Alergia: badanie kliniczne

Kryteria wyłączenia kto nie może wziąć udziału (11)

1. Allergic reaction at the lowest challenge dose of 1 mg of allergen protein for any allergen, or no allergic reaction after administration of the maximum dose of 3000 mg of allergen protein for at least four of the analyzed allergens;
2. History of anaphylaxis with a grade V reaction according to the WAO classification, either during an oral food challenge or in the patient's medical history;
3. Severe asthma;
4. Poorly controlled asthma according to GINA 2025 (lack of symptom control and/or ≥2 exacerbations requiring systemic glucocorticoids or ≥1 exacerbation requiring hospitalization within the last 12 months), or in children able to perform spirometry: FEV1 < -1.64 Z-score and/or FEV1/FVC < -1.64 Z-score;
5. Eosinophilic gastrointestinal disease;
6. Other chronic diseases requiring ongoing treatment which, in the investigator's opinion, may increase the risk associated with study participation or interfere with the interpretation of results, including severe cardiac disease, epilepsy, metabolic disorders, or diabetes;
7. Previous immunotherapy with food allergens;
8. Concurrent immunotherapy with aeroallergens;
9. Treatment with biologic agents, beta-blockers, ACE inhibitors, or calcium channel blockers;
10. Oral corticosteroid therapy meeting any of the following criteria: daily treatment for >1 month within the last 12 months; at least two courses lasting ≥7 days within the last 12 months; one course lasting ≥7 days within the last 3 months;
11. Lack of consent to participate in the study or insufficient cooperation of the patient and/or caregivers. In such cases, patients will receive standard medical care, including allergen avoidance and provision of emergency medication. Well-controlled asthma, allergic rhinitis, and atopic dermatitis are not exclusion criteria.