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

Inmunotek

Status: Completed

Conditions: Immune System Diseases

Treatments: Diagnostic Test: Allergen extracts

Study type: Interventional

Funder types: Industry

Identifiers

NCT02527122

2013-005394-45 (EudraCT Number)

MM09-STD-011

Details and patient eligibility

About

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..

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Allergen extracts

Experimental group

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.

Treatment:

Diagnostic Test: Allergen extracts