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Determination of Biological Activity of Three Allergen Extracts

Primary Purpose

Hypersensitivity

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Skin Prick Test - Atopic subjects
Skin Prick Test - Non Atopic subjects
Skin Prick Test - Allergic subjects
Sponsored by
Roxall Medicina España S.A
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypersensitivity focused on measuring Allergy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

A. Subjects sensitized to one or more allergen extracts:

  1. Positive clinical history with inhalant allergy to at least one of the allergen to be standardized.
  2. At least one positive prick test (mean wheal diameter greater or equal than 3mm)
  3. Positive prick test (wheal diameter greater or equal to 3 mm) to Histamine 10 mg/ml
  4. Age: 18-60 years
  5. Written informed consent

  6. Patients will be:preferably be monosensitized, or with clinically relevant sensitization , or with primary sensitization (maximum cutaneous reactivity) to the extracts under investigation.Patient who belongs to one of the following group:

    • Monosensitized patient to one of the extracts under investigation
    • Patient with clinically relevant sensitization to the extracts under investigation.
    • Patient with primary sensitization to one of the extracts under investigation
  7. Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.

B. Atopic Subjects:

  1. Age: 18-60 years
  2. Written informed consent
  3. Positive prick test (wheal diameter greater or equal to 3 mm) to Histamine 10 mg/ml
  4. Negative prick test (mean wheal diameter less or equal to 3mm) when tested with already standardized extracts of the allergens under investigation or with cross reactive extracts.
  5. Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.

C. No Atopic Subjects:

  1. Age: 18-60 years.
  2. Written informed consent
  3. Positive prick test (wheal diameter greater or equal to 3 mm) to Histamine 10 mg/ml

  4. Wheal diameter greater or equal to 3 mm for:

    • Any allergen, except pollen for the cases of Artemisia vulgaris and/or Platanus acerifolia pollen extracts.
    • Any allergen, except mites for the case of Dermatophagoides farinae mite extract.

  5. In order to dismiss sensitization to other allergens, the wheal diameter should be less than 3 mm for:

    • Any pollen (for the cases of Artemisia vulgaris and/or Platanus acerifolia pollen extracts)
    • Any mites(for the case of Dermatophagoides farinae mite extract)
  6. Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.

Exclusion Criteria (shared by the 3 groups):

  1. Immunotherapy in the 5 years prior to the study against either the allergen to be tested or an allergen which is cross-reactive. (it is not applicable to no atopic patients)
  2. Any drug which may interfere with the cutaneous test or with its result.
  3. Any medical condition that from investigator's point of view the skin prick test cannot be done .
  4. Women who are pregnant or breast-feeding or are child-bearing age and who have not demonstrated that they have been surgically sterilized or have other means of not bearing children.
  5. Subjects who have participated in another clinical trial within 3 months prior to this study.

Sites / Locations

  • Hospital de Vinalopó
  • Alergoclínica Virgen de Loreto
  • Hospital General de Asturias
  • Al-lergo centre
  • Hospital Universitario de Gran Canaria Dr. Negrín
  • Clínica de asma y alergia
  • Hospital Nuestra Señora De Candelaria
  • Hospital Arnau de Vilanova
  • Hospital Clínico de Valencia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Atopic subjects

Non atopic subjects

Allergic Subjects

Arm Description

Patients sensitized to other allergenic sources but the allergen extracts under investigation.

Healthy volunteers

Outcomes

Primary Outcome Measures

Wheal size area
The primary efficacy variable will be the wheal size area at the site of the puncture of the immediate phase reaction in mm2.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2013
Last Updated
April 28, 2017
Sponsor
Roxall Medicina España S.A
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1. Study Identification

Unique Protocol Identification Number
NCT02474836
Brief Title
Determination of Biological Activity of Three Allergen Extracts
Official Title
Biological Standardization of Artemisia Vulgaris and/or Platanus Acerifolia Pollen Extract and Dermatophagoides Farinae Mite Extract in Patients Sensitized to Them
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roxall Medicina España S.A

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. Many factors such as the variability, differences in extraction process and subsequent handling of allergens can affect the final composition, potency, and stability of allergen preparations. Genetic diversity of affected people adds another level of complexity. In order to control variability and to achieve consistency and reproducibility for optimal safety and sensitivity/specificity, it is essential to standardize the amount of allergen used in prick tests. Therefore, the system for biological standardization mainly used in Europe still is the biological calibration of in-House Reference Preparations (IHRP). The method has been adopted by the Nordic Council on Medicines as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick Test (SPT) value. The aim of this procedure is to estimate the biological activity of allergen extracts. The activity of an allergen extract is defined as 1 SPT per ml, when the extract provokes a specific skin reaction with a wheal of the same size as a wheal provoked by reference histamine at a concentration of 10 mg/ml, when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are sensitized to the allergen concerned. The present study aims to standardize the allergen extracts of Artemisia vulgaris, Platanus acerifolia, Dermatophagoides farinae by using this method.
Detailed Description
The present study aims to standardize the allergen extracts of Artemisa vulgaris, Platanus acerifolia and Dermatophagoides farinae by using this method. Standardized extracts will then be used for diagnostics and treatment of allergies as mentioned above.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atopic subjects
Arm Type
Active Comparator
Arm Description
Patients sensitized to other allergenic sources but the allergen extracts under investigation.
Arm Title
Non atopic subjects
Arm Type
Active Comparator
Arm Description
Healthy volunteers
Arm Title
Allergic Subjects
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Skin Prick Test - Atopic subjects
Intervention Description
Skin prick test of 4 concentrations of each allergenic source, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. Assessment of the wheal size after 15 minutes.
Intervention Type
Biological
Intervention Name(s)
Skin Prick Test - Non Atopic subjects
Intervention Description
Skin prick test of 4 concentrations of each allergenic source, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every subjects in duplicate on the volar surface of the forearm. Assessment of the wheal size after 15 minutes.
Intervention Type
Biological
Intervention Name(s)
Skin Prick Test - Allergic subjects
Intervention Description
Skin prick test of 4 concentrations of each allergenic source, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. Assessment of the wheal size after 15 minutes.
Primary Outcome Measure Information:
Title
Wheal size area
Description
The primary efficacy variable will be the wheal size area at the site of the puncture of the immediate phase reaction in mm2.
Time Frame
15 minutes after skin prick test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A. Subjects sensitized to one or more allergen extracts: Positive clinical history with inhalant allergy to at least one of the allergen to be standardized. At least one positive prick test (mean wheal diameter greater or equal than 3mm) Positive prick test (wheal diameter greater or equal to 3 mm) to Histamine 10 mg/ml Age: 18-60 years Written informed consent Patients will be:preferably be monosensitized, or with clinically relevant sensitization , or with primary sensitization (maximum cutaneous reactivity) to the extracts under investigation.Patient who belongs to one of the following group: Monosensitized patient to one of the extracts under investigation Patient with clinically relevant sensitization to the extracts under investigation. Patient with primary sensitization to one of the extracts under investigation Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study. B. Atopic Subjects: Age: 18-60 years Written informed consent Positive prick test (wheal diameter greater or equal to 3 mm) to Histamine 10 mg/ml Negative prick test (mean wheal diameter less or equal to 3mm) when tested with already standardized extracts of the allergens under investigation or with cross reactive extracts. Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study. C. No Atopic Subjects: Age: 18-60 years. Written informed consent Positive prick test (wheal diameter greater or equal to 3 mm) to Histamine 10 mg/ml Wheal diameter greater or equal to 3 mm for: Any allergen, except pollen for the cases of Artemisia vulgaris and/or Platanus acerifolia pollen extracts. Any allergen, except mites for the case of Dermatophagoides farinae mite extract. In order to dismiss sensitization to other allergens, the wheal diameter should be less than 3 mm for: Any pollen (for the cases of Artemisia vulgaris and/or Platanus acerifolia pollen extracts) Any mites(for the case of Dermatophagoides farinae mite extract) Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study. Exclusion Criteria (shared by the 3 groups): Immunotherapy in the 5 years prior to the study against either the allergen to be tested or an allergen which is cross-reactive. (it is not applicable to no atopic patients) Any drug which may interfere with the cutaneous test or with its result. Any medical condition that from investigator's point of view the skin prick test cannot be done . Women who are pregnant or breast-feeding or are child-bearing age and who have not demonstrated that they have been surgically sterilized or have other means of not bearing children. Subjects who have participated in another clinical trial within 3 months prior to this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Araitz Landeta
Organizational Affiliation
Roxall Medicina España S.A
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Vinalopó
City
Elche
State/Province
Alicante
Country
Spain
Facility Name
Alergoclínica Virgen de Loreto
City
Córdoba
State/Province
Andalucía
Country
Spain
Facility Name
Hospital General de Asturias
City
Oviedo
State/Province
Asturias
Country
Spain
Facility Name
Al-lergo centre
City
Barcelona
State/Province
Cataluña
Country
Spain
Facility Name
Hospital Universitario de Gran Canaria Dr. Negrín
City
Las Palmas de Gran Canaria
Country
Spain
Facility Name
Clínica de asma y alergia
City
Madrid
Country
Spain
Facility Name
Hospital Nuestra Señora De Candelaria
City
Santa Cruz de Tenerife
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Valencia
Country
Spain
Facility Name
Hospital Clínico de Valencia
City
Valencia
Country
Spain

12. IPD Sharing Statement

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Determination of Biological Activity of Three Allergen Extracts

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