Standardizing allergen extracts from Quercus ilex and Quercus robur
Quercus Ilex and Quercus Robur Allergen Extracts. Determination of the in Vivo Allergenic Potency in Histamine Equivalent Units (HEP).
This study is testing how strong allergen extracts from two types of oak trees are to help people with allergies by using skin tests and blood samples.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Inmunotek S.L. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05532566 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the biological activity of allergen extracts from Quercus ilex and Quercus robur using histamine equivalent prick (HEP) units. Participants will undergo a single visit where they will provide demographic data, clinical history, and undergo prick tests with various concentrations of the allergenic extracts. Blood samples will be collected to create a pool of sera for in vitro standardization tests, which are essential for characterizing the allergenic extracts and producing an in-house reference preparation (IHRP). The study adheres to guidelines set by the Royal Spanish Pharmacopoeia and the European Pharmacopoeia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 64 with a positive clinical history of inhalant allergy to Quercus ilex and Quercus robur.
Not a fit: Patients who have received immunotherapy for related allergies in the past five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved standardization of allergenic extracts, enhancing the accuracy of allergy diagnosis and treatment.
How similar studies have performed: While this approach is based on established methodologies, the specific standardization of these particular allergenic extracts is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid
- Clínica Subiza, centro de asma y alergia — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Javier Subiza, MD — Clinica Subiza, centro de asma y alergia
- Study coordinator: Miguel Casanovas, MD
- Email: mcasanovas@inmunotek.com
- Phone: +34912908942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.