Standardizing allergen extracts from Quercus ilex and Quercus robur

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.