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Quercus Ilex and Quercus Robur Allergen Extracts Standardisation

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ClinicalTrials.gov Identifier: NCT05532566
Recruitment Status : Not yet recruiting
First Posted : September 8, 2022
Last Update Posted : September 8, 2022
Sponsor:
Information provided by (Responsible Party):
Inmunotek S.L.

Tracking Information
First Submitted Date  ICMJE September 5, 2022
First Posted Date  ICMJE September 8, 2022
Last Update Posted Date September 8, 2022
Estimated Study Start Date  ICMJE January 2, 2023
Estimated Primary Completion Date January 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2022)
  • Size of the induced papule on the skin [ Time Frame: 15 minutes ]
    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 [ Time Frame: 30 minutes ]
    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.).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quercus Ilex and Quercus Robur Allergen Extracts Standardisation
Official Title  ICMJE Quercus Ilex and Quercus Robur Allergen Extracts. Determination of the in Vivo Allergenic Potency in Histamine Equivalent Units (HEP).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Phase II, open-label, non-randomized trial, with no control group of subjects.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Allergic Reaction
  • Allergic Skin Reaction
  • Allergy Pollen
Intervention  ICMJE Other: 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.
Other Name: Allergenic Quercus ilex and Quercus robur extract
Study Arms  ICMJE Experimental: Extract Q. ilex + extract Q. robur + 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 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

Intervention: Other: Allergenic extract
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2022)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2024
Estimated Primary Completion Date January 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Miguel Casanovas 912908942 ext 34 mcasanovas@inmunotek.com
Contact: Raquel Caballero 607600638 ext 34 rcaballero@inmunotek.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05532566
Other Study ID Numbers  ICMJE T525-STD-043
2020-005388-30 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Inmunotek S.L.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Inmunotek S.L.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Javier Subiza, DM Clinica Subiza, centro de asma y alergia
PRS Account Inmunotek S.L.
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP