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Recruiting NCT05532566

Quercus Ilex and Quercus Robur Allergen Extracts Standardisation

Trial Parameters

Condition Allergic Reaction
Sponsor Inmunotek S.L.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 64 Years
Start Date 2023-01-24
Completion 2025-11-30
Interventions
Allergenic extract

Brief Summary

The objective of this study is to determine the biological activity of Quercus illex and Quercus robur allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

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 wi

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