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Determination of Biological Activity of Three Allergen Extracts

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ClinicalTrials.gov Identifier: NCT02474836
Recruitment Status : Completed
First Posted : June 18, 2015
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Roxall Medicina España S.A

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.


Condition or disease Intervention/treatment Phase
Hypersensitivity Biological: Skin Prick Test - Atopic subjects Biological: Skin Prick Test - Non Atopic subjects Biological: Skin Prick Test - Allergic subjects Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Biological Standardization of Artemisia Vulgaris and/or Platanus Acerifolia Pollen Extract and Dermatophagoides Farinae Mite Extract in Patients Sensitized to Them
Study Start Date : November 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Atopic subjects
Patients sensitized to other allergenic sources but the allergen extracts under investigation.
Biological: Skin Prick Test - Atopic subjects
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.

Active Comparator: Non atopic subjects
Healthy volunteers
Biological: Skin Prick Test - Non Atopic subjects
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.

Allergic Subjects Biological: Skin Prick Test - Allergic subjects
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 Measures :
  1. Wheal size area [ Time Frame: 15 minutes after skin prick test ]
    The primary efficacy variable will be the wheal size area at the site of the puncture of the immediate phase reaction in mm2.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474836


Locations
Spain
Hospital de Vinalopó
Elche, Alicante, Spain
Alergoclínica Virgen de Loreto
Córdoba, Andalucía, Spain
Hospital General de Asturias
Oviedo, Asturias, Spain
Al-lergo centre
Barcelona, Cataluña, Spain
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Spain
Clínica de asma y alergia
Madrid, Spain
Hospital Nuestra Señora De Candelaria
Santa Cruz de Tenerife, Spain
Hospital Arnau de Vilanova
Valencia, Spain
Hospital Clínico de Valencia
Valencia, Spain
Sponsors and Collaborators
Roxall Medicina España S.A
Investigators
Study Chair: Araitz Landeta Roxall Medicina España S.A

Responsible Party: Roxall Medicina España S.A
ClinicalTrials.gov Identifier: NCT02474836     History of Changes
Other Study ID Numbers: BIA-STD-003
2012-000672-42 ( EudraCT Number )
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017

Keywords provided by Roxall Medicina España S.A:
Allergy

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs