NCT06957496

Phleum Pratense and Dactylis Glomerata Allergen Extracts Standardization

Phleum Pratense and Dactylis Glomerata Allergen Extracts. Determination of the in Vivo Histamine Equivalent Prick Test Units

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Inmunotek S.L. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Detailed description

The trial will consist of a single visit, in which the following procedures will be carried out: * Demographic data (age, race, and gender). * Medical history: Time of onset of allergic rhinitis, rhinoconjunctivitis, allergic asthma and sensitizations (positive skin prick test) to allergens other than Phleum pratense and Dactylis glomerata. * Inclusion/exclusion criteria. * Physical examination (Cardiovascular, pulmonary, neurobiological, gastrointestinal, dermatological, other body systems and height, weight). * Pregnancy test. Women of childbearing age will undergo a urine pregnancy test. * Performance of prick-tests (3 concentrations of Phleum pratense and Dactylis glomerata allergenic extracts, positive control and negative control). * Collection of blood sample (20 mL) from the subjects to create a pool of sera for the "in vitro" standardization of the allergenic extracts. Each serum sample will be stored in a tube labeled with the subject number and frozen. These serum samples will remain in the freezer until the end of the study. When the study is completed, they will be transported to the laboratory, where all sera will be pooled. This "pool" of sera will be used to perform the complementary in vitro tests necessary to standardize and characterize this extract and produce its corresponding IHRP (In-house reference preparation), as indicated by the Royal Spanish Pharmacopoeia and the European Pharmacopoeia. In addition, it will be used in the in vitro analyses necessary for the standardization of new batches of this allergenic extract. Once the pool has been formed, the tubes containing the original serum samples are destroyed. * Assesment of adverse events. The trial will also include a follow-up call 72 hours after the prick tests are performed to monitor possible adverse events.

Conditions

• Allergy Pollen
• Allergic Reaction
• Allergic Skin Reaction

Interventions

Type	Name	Description
OTHER	Allergenic extracts	In each subject, a drop of each of the 3 concentrations of the allergenic extract, in addition to the positive control (histamine) and the negative control, will be applied. The application will be duplicated on the subject's anterior forearm, with a distance of approximately 4 cm between each application to avoid overlapping reactions and false-positives results.

Timeline

• Start date: 2024-12-09
• Primary completion: 2025-01-13
• Completion: 2025-01-16
• First posted: 2025-05-04
• Last updated: 2025-10-02

Locations

1 site across 1 country: Spain