Clinical trial NCT05533385: Juniperus Oxycedrus and Cupressus Arizonica Allergen Extracts Standardisation.
Official title: Juniperus Oxycedrus and Cupressus Arizonica Allergen Extracts. Determination of the in Vivo Allergenic Potency in Histamine Equivalent Units (HEP).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy Pollen
Allergic Reaction
Allergic Skin Reaction
Keywords: Allergy
Lead sponsor: Inmunotek S.L.
Sponsor class: INDUSTRY
First posted: 2022-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase II, open-label, non-randomized trial, with no control group of subjects.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Size of the induced papule on the skin
timeFrame: 15 minutes
measure: Adverse reactions
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clínica Subiza, centro de asma y alergia
Study officials:
affiliation: Clinica Subiza, centro de asma y alergia
name: Javier Subiza, DM
role: PRINCIPAL_INVESTIGATOR
References: