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Quercus Ilex and Quercus Robur Allergen Extracts Standardisation

Primary Purpose

Allergic Reaction, Allergic Skin Reaction, Allergy Pollen

Status

Not yet recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Allergenic extract

About this trial

This is an interventional other trial for Allergic Reaction focused on measuring Allergy

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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 with Quercus ilex and Quercus robur 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.

Sites / Locations

Clínica Subiza, centro de asma y alergia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Extract Q. ilex + extract Q. robur + positive control + negative control

Arm Description

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 10mg/mL) and the negative control, with prick test. Quercus ilex: 2,500, 500 and 100 μg/mL Quercus robur: 2,500, 500 and 100 μg/mL

Outcomes

Primary Outcome Measures

Size of the induced papule on the skin

Size of the induced papule on the skin when applying each of the concentrations of the allergenic extracts and the positive (histamine) and negative controls, using the prick test.

Adverse reactions

Mild secondary reactions such as pruritus, erythema, local edema, etc. There is a risk, infrequent and exceptional, of systemic reactions, sometimes severe (urticaria, asthma, anaphylactic shock, etc.).

Secondary Outcome Measures

Full Information

NCT ID

NCT05532566

First Posted

September 5, 2022

Last Updated

September 5, 2022

Sponsor

Inmunotek S.L.

1. Study Identification

Unique Protocol Identification Number

NCT05532566

Brief Title

Quercus Ilex and Quercus Robur Allergen Extracts Standardisation

Official Title

Quercus Ilex and Quercus Robur Allergen Extracts. Determination of the in Vivo Allergenic Potency in Histamine Equivalent Units (HEP).

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2, 2023 (Anticipated)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Inmunotek S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

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. General examination. Performance of prick-tests (3 concentrations of Quercus ilex allergenic extract, 3 concentrations of Quercus robur 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. This pool of sera is necessary for the characterization of the Company's standard. Each serum sample will be stored in a tube that will be labeled with the subject number and frozen. These serum samples will remain in the freezer until the study is completed. 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 standardization tests. These include ELISA for measurement of inhibition against specific IgE, etc. These serum samples are not destroyed. They are pooled together to form a pool that will be used, as described in the previous paragraph, in all the in vitro tests necessary to standardize and characterize this extract and produce its corresponding HIRP (In-house reference preparation), as indicated by the Royal Spanish Pharmacopoeia and the European Pharmacopoeia. This pool of sera is not destroyed, it is 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Reaction, Allergic Skin Reaction, Allergy Pollen

Keywords

Allergy

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Phase II, open-label, non-randomized trial, with no control group of subjects.

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Extract Q. ilex + extract Q. robur + positive control + negative control

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Allergenic extract

Other Intervention Name(s)

Allergenic Quercus ilex and Quercus robur extract

Intervention Description

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.

Primary Outcome Measure Information:

Title

Size of the induced papule on the skin

Description

Size of the induced papule on the skin when applying each of the concentrations of the allergenic extracts and the positive (histamine) and negative controls, using the prick test.

Time Frame

15 minutes

Title

Adverse reactions

Description

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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 with Quercus ilex and Quercus robur 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Miguel Casanovas

Phone

912908942

Ext

mcasanovas@inmunotek.com

First Name & Middle Initial & Last Name or Official Title & Degree

Raquel Caballero

Phone

607600638

Ext

rcaballero@inmunotek.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Javier Subiza, DM

Organizational Affiliation

Clinica Subiza, centro de asma y alergia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clínica Subiza, centro de asma y alergia

City

Madrid

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Javier Subiza, DM

12. IPD Sharing Statement

Citations:

PubMed Identifier

9383897

Citation

Sjoholm I. Standardisation of allergens in Europe. Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M. 1997;(91):107-10.

Results Reference

background

PubMed Identifier

31177492

Citation

Larsen JN, Dreborg S. Standardization of Allergen Extracts. Methods Mol Biol. 2019;2020:63-76. doi: 10.1007/978-1-4939-9591-2_5.

Results Reference

background

PubMed Identifier

6625583

Citation

Arntzen FC. Progress in common Nordic Guidelines for the Registration of Allergen Preparations. Arb Paul Ehrlich Inst Georg Speyer Haus Ferdinand Blum Inst Frankf A M. 1983;(78):25-8. No abstract available.

Results Reference

background

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Quercus Ilex and Quercus Robur Allergen Extracts Standardisation

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