Clinical trial NCT02527122: Biological Stardadization of D. Pteronyssinus and D. Farinae Allergen Extracts
Official title: Dermatophagoides Pteronyssinus and Dermatophagoides Farinae Allergen Extract. Determination of the Allergenic Potency in Vivo Histamine Equivalent Units (HEP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune System Diseases
Keywords: Immune System Diseases
Prick Test
Dermatophagoides pteronyssinus
Dermatophagoides farinae
Lead sponsor: Inmunotek S.L.
Sponsor class: INDUSTRY
First posted: 2015-08-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: 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
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Sta. Cruz de Tenerife
country: Spain
facility: Hospital Univ. Ntra. Sra. de la Candelaria
state: Islas Canarias
Study officials:
name: Elena Rodríguez, MD
role: STUDY_DIRECTOR
References: