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

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

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..

Study Overview

• Status: Completed
• Conditions: Immune System Diseases
• Intervention / Treatment: Diagnostic test: Allergen extracts

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Islas Canarias
    • Sta. Cruz de Tenerife, Islas Canarias, Spain, 38010,
      • Hospital Univ. Ntra. Sra. de la Candelaria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Allergen extracts; 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.

Diagnostic test: Allergen extracts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 hour

Collaborators and Investigators

• Sponsor: Inmunotek S.L.
• Investigators: Study Director: Elena Rodríguez, MD

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: August 17, 2015
• First Posted (Estimate): August 18, 2015

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Immune System Diseases; Prick Test; Dermatophagoides farinae; Dermatophagoides pteronyssinus
• Additional Relevant MeSH Terms: Immune System Diseases
• Other Study ID Numbers: MM09-STD-011; 2013-005394-45 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No