Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT05532566
Eligibility Criteria:
Inclusion Criteria:
* Subjects must live in a geographical area where allergic problems caused by Quercus ilex and Quercus robur are relevant.
* Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to asthma) to Quercus ilex and Quercus robur.
* A positive prick-test (mean papule diameter ≥ 3 mm) with an extract of the same allergen and/or presence of specific IgE against that allergen.
* The mean papule area obtained with Histamine dichlorhydrate at 10 mg/mL should be ≥ 7 mm2.
* Age: Between 18 and 64 years old.
* Subjects must be able to give informed consent.
Exclusion Criteria:
* Subjects should not be excluded in terms of low or high sensitivity to Quercus ilex and Quercus robur.
* Subjects outside the age range.
* Subjects who have previously received immunotherapy in the last 5 years for the treatment of asthma or rhinoconjunctivitis for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with Quercus ilex and Quercus robur extracts.
* Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated.
* Subjects who have previously presented a severe secondary reaction during the performance of diagnostic skin tests by prick test.
* Subjects under treatment with ß-blockers.
* Subjects clinically unstable (acute asthma, febrile, etc.).
* Subjects with active urticaria lesions, severe active dermographism, severe atopic dermatitis, sunburn, eczema, psoriasis lesions in the area where the prick test is performed (risk of false positives).
* Subjects with active viral infection by herpes simplex or herpes varicella zoster in the area where the prick test is performed.
* Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HTA, cardiopathy, etc.).
* States of the subject in which he/she cannot offer cooperation and severe psychiatric disorders.
* Pregnant women or women at risk of pregnancy and lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT05532566
Study Brief:
Protocol Section:
NCT05532566