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Biological Stardadization of D. Pteronyssinus and D. Farinae Allergen Extracts (MM09)

Primary Purpose

Immune System Diseases

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Allergen extracts

About this trial

This is an interventional diagnostic trial for Immune System Diseases focused on measuring Immune System Diseases, Prick Test, Dermatophagoides pteronyssinus, Dermatophagoides farinae

Eligibility Criteria

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

Inclusion Criteria:

Clinical history positive inhalation allergy (rhinitis I rhinoconjunctivitis I asthma) against Dermatophagoides pteronyssinus or Dermatophagoides farinae.
A prick-test positive (average of the papule ≥ 3 mm diameter) with a summary of the same allergen I presence against the allergen specific Immunoglobulin E.
The average area of the papule obtained by histamine dihydrochloride to 10 mgml must be greater than or equal 7 mm2.
Age: over 18 years of age.
Both sexes.

Exclusion Criteria:

Subjects outside of the age range.
Individuals who have previously received immunotherapy in the last 5 years for the treatment of asthma or the allergic rhinoconjunctivitis induced by allergens that may interfere with the extract mixture of Dermatophagoides pteronyssinus or farinae.
Subjects with important symptoms of rhinoconjunctivitis I bronchial asthma in which the suspension of the antihistamine treatment for systemic is contraindicated.
Subjects that have previously submitted a serious secondary reaction during skin prick test diagnostic tests.
Subjects in treatment with ss-blockers.
Unstable subjects of clinical point of view (asthma acute, febrile, etc.).
Subjects with lesions of active hives, severe active dermographism, severe atopic dermatitis, sunburn, eczema, lesions of psoriasis in the area of realization of the prick test (risk of false positives).
Subjects with viral infection activates the herpes simplex or herpes varicella-zoster in the area of realization of the prick test.
Subjects that have some pathology in which the administration of adrenaline (hyperthyroidism, hypertension, heart disease, etc.) is contraindicated.
States of the subject that can not offer cooperation and severe psychiatric disorders.
Pregnant or women at risk of pregnancy and breastfeeding women.

Sites / Locations

Hospital Univ. Ntra. Sra. de la Candelaria

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allergen extracts

Arm Description

Skin prick test of 4 concentrations of D. pteronyssinus allergen extract, 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 one forearm. Assessment of the wheal size after 15 minutes. Skin prick test of 4 concentrations of D. farinae allergen extract, 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 other forearm. Assessment of the wheal size after 15 minutes.

Outcomes

Primary Outcome Measures

The wheal size diameter on the skin at the site of the puncture during the immediate phase when applied each concentration of the allergen extract

wheal size diameter OF THE SKIN PRICK TEST

Secondary Outcome Measures

Full Information

NCT ID

NCT02527122

First Posted

August 17, 2015

Last Updated

August 7, 2018

Sponsor

Inmunotek S.L.

1. Study Identification

Unique Protocol Identification Number

NCT02527122

Brief Title

Biological Stardadization of D. Pteronyssinus and D. Farinae Allergen Extracts

Acronym

MM09

Official Title

Dermatophagoides Pteronyssinus and Dermatophagoides Farinae Allergen Extract. Determination of the Allergenic Potency in Vivo Histamine Equivalent Units (HEP)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

July 21, 2016 (Actual)

Primary Completion Date

July 2018 (Actual)

Study Completion Date

August 2018 (Actual)

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

Four concentrations of Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen extracts, 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..

Detailed Description

This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.

6. Conditions and Keywords

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

Immune System Diseases

Keywords

Immune System Diseases, Prick Test, Dermatophagoides pteronyssinus, Dermatophagoides farinae

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Allergen extracts

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Allergen extracts

Primary Outcome Measure Information:

Title

The wheal size diameter on the skin at the site of the puncture during the immediate phase when applied each concentration of the allergen extract

Description

wheal size diameter OF THE SKIN PRICK TEST

Time Frame

1 hour

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: Clinical history positive inhalation allergy (rhinitis I rhinoconjunctivitis I asthma) against Dermatophagoides pteronyssinus or Dermatophagoides farinae. A prick-test positive (average of the papule ≥ 3 mm diameter) with a summary of the same allergen I presence against the allergen specific Immunoglobulin E. The average area of the papule obtained by histamine dihydrochloride to 10 mgml must be greater than or equal 7 mm2. Age: over 18 years of age. Both sexes. Exclusion Criteria: Subjects outside of the age range. Individuals who have previously received immunotherapy in the last 5 years for the treatment of asthma or the allergic rhinoconjunctivitis induced by allergens that may interfere with the extract mixture of Dermatophagoides pteronyssinus or farinae. Subjects with important symptoms of rhinoconjunctivitis I bronchial asthma in which the suspension of the antihistamine treatment for systemic is contraindicated. Subjects that have previously submitted a serious secondary reaction during skin prick test diagnostic tests. Subjects in treatment with ss-blockers. Unstable subjects of clinical point of view (asthma acute, febrile, etc.). Subjects with lesions of active hives, severe active dermographism, severe atopic dermatitis, sunburn, eczema, lesions of psoriasis in the area of realization of the prick test (risk of false positives). Subjects with viral infection activates the herpes simplex or herpes varicella-zoster in the area of realization of the prick test. Subjects that have some pathology in which the administration of adrenaline (hyperthyroidism, hypertension, heart disease, etc.) is contraindicated. States of the subject that can not offer cooperation and severe psychiatric disorders. Pregnant or women at risk of pregnancy and breastfeeding women.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elena Rodríguez, MD

Official's Role

Study Director

Facility Information:

Facility Name

Hospital Univ. Ntra. Sra. de la Candelaria

City

Sta. Cruz de Tenerife

State/Province

Islas Canarias

ZIP/Postal Code

38010,

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Biological Stardadization of D. Pteronyssinus and D. Farinae Allergen Extracts

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