Juniperus Oxycedrus and Cupressus Arizonica Allergen Extracts Standardisation.

NCT ID: NCT05533385

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2024-01-22

Brief Summary

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

Detailed Description

The trial will consist of a single visit, in which the following procedures will be carried out:

• Demographic data.
• Clinical history.
• Inclusion/exclusion criteria.
• Physical examination.
• Pregnancy test.
• Performance of prick-tests (3 concentrations of Juniperus oxycedrus and Cupressus arizonica allergenic extract, positive control and negative control).
• Obtaining a blood sample from the patient to create a pool of sera for the "in vitro" standardization of the allergenic extract.
• 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.
• Evaluation of adverse events.

Conditions

Allergy Pollen; Allergic Reaction; Allergic Skin Reaction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Extract J. oxycedrus + extract C. arizonica + positive control + negative control

There is only one treatment arm. In each subject, one drop of each of the 3 concentrations of each allergenic extract (2 extracts) will be applied in addition to the positive control (histamine 10 mg/mL) and the negative control, with prick test.

Juniperus oxycedrus: 300, 60 and 12 µg/mL Cupressus arizonica: 100, 20 and 4 µg/mL

Group Type: EXPERIMENTAL

Allergenic extract

Intervention Type: OTHER

In each subject a drop of each of the 3 concentrations of both allergenic extracts will be applied in addition to the positive control (histamine) and the negative control. The application will be made in duplicate on the anterior face of the subject's arm. The distance between each application should be approximately 4 cm.

Interventions

Allergenic extract

In each subject a drop of each of the 3 concentrations of both allergenic extracts will be applied in addition to the positive control (histamine) and the negative control. The application will be made in duplicate on the anterior face of the subject's arm. The distance between each application should be approximately 4 cm.

Intervention Type: OTHER

Other Intervention Names

Allergenic Juniperus oxycedrus and Cupressus arizonica extract

Eligibility Criteria

Inclusion Criteria

• Subjects must live in a geographical area where allergic problems caused by Juniperus oxycedrus and Cupressus arizonica are relevant.
• Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to asthma) to Juniperus oxycedrus and Cupressus arizonica.
• 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.
• Both sexes.
• Subjects must be able to give informed consent.
• Women of childbearing age (since menarche) must present a negative urine pregnancy test at the time of enrollment in the trial.

Exclusion Criteria

• Subjects should not be excluded in terms of low or high sensitivity to Juniperus oxycedrus and Cupressus arizonica.
• 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 Juniperus oxycedrus and Cupressus arizonica 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inmunotek S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier Subiza, DM

Role: PRINCIPAL_INVESTIGATOR

Clinica Subiza, centro de asma y alergia

Locations

Clínica Subiza, centro de asma y alergia

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

2020-005389-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

T521-STD-044

Identifier Type: -

Identifier Source: org_study_id