Phleum Pratense and Dactylis Glomerata Allergen Extracts Standardization
Spain31 participantsStarted 2024-12-09
Plain-language summary
The primary objective is to assess the concentration of each allergen extract (Phleum pratense and Dactylis glomerata) that induces a wheal size equivalent to that produced by a 10 mg/mL histamine dihydrochloride solution. The standardization procedure is carried out according to the Aas Method as specified in the guideline developed by the Nordic Council on Medicines
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion Criteria:
* Subjects who have signed and dated informed consent form.
* Female or male aged 18 to 64 years, both included.
* Subjects must reside in a geographical area where allergic problems caused by Phleum pratense and Dactylis glomerata are relevant.
* Positive medical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to Phleum pratense and Dactylis glomerata.
* A positive prick-test (mean wheal diameter ≥ 3 mm) with extracts of the same allergens and/or presence of specific IgE against complete extract or any molecular component to the allergenic sources.
* The area of the wheal obtained with 10 mg/mL histamine dihydrochloride should be ≥ 7 mm², which corresponds to a mean wheal diameter ≥ 3 mm.
* The area of the wheal obtained with negative control should be \< 7 mm², which corresponds to a mean wheal diameter \< 3 mm.
* Women of childbearing age (i.e following menarche and until postmenopause, defined as no menses for 12 months without an alternative medical cause, or non-subject to permanent sterilization methods, such as hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) must present a negative urine pregnancy test at the time of enrollment in the trial, as well as a confirmed menstrual period.
* Women of childbearing age must commit to using a highly effective and adequate contraception method during the trial and up to 72 hours after the end of treatment with the investigational medicinal product. Such metho…