Clinical trial NCT01821716: Biological Standardization of Dermatophagoides Pteronyssinus Allergen Extract
Official title: Biological Standardization of Dermatophagoides Pteronyssinus Allergen Extract to Determine the Biological Activity in HEP Units.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergy Dermatophagoides Pteronyssinus
Allergic Rhinitis
Allergic Asthma
Keywords: standardization
skin prick test
inmunotherapy
Lead sponsor: Laboratorios Leti, S.L.
Sponsor class: INDUSTRY
First posted: 2013-04-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to determine the biologic activity of a Dermatophagoides pteronyssinus allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

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.

Three concentrations of Dermatophagoides 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 the forearm.

Eligibility criteria: Inclusion Criteria:

* Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).
* Subject can be male or female of any race and ethnic group.
* Age \> and =18 years and \< and =60 years at the study inclusion day.
* Medical history of allergy with respiratory symptoms (rhinitis and /or rhinoconjunctivitis and/or asthma) to Dermatophagoides pteronyssinus.
* Positive skin prick test with a standardized commercially available preparation of Dermatophagoides pteronyssinus allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm or an area at least 7 mm2. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study
* A positive test for specific IgE to Dermatophagoides pteronyssinus (CAP-RAST major or equal to 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.

Exclusion Criteria:

* Immunotherapy in the past 5 years with a Dermatophagoides pteronyssinus allergen extract or other mites allergen extracts known to interfere with the allergen to be tested, due to a high degree of cross-reactivity.
* Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1 of the protocol.
* Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants or IMAOs, beta-blockers, chronic use of corticosteroids or use of oral or parenteral corticosteroids in repeated and intermittent patterns (10 mg/daily of prednisone or equivalent).
* Women who are pregnant or period of breastfeeding and women with a pregnancy test positive during the visit 2, prior to the prick test.
* Dermographism affecting the skin area at the test site at either study visit.
* Atopic dermatitis affecting the skin area at the test site at either study visit.
* Urticaria affecting the skin area at the test site at either study visit.
* Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies.
* Serious diseases not controlled that may increase the risk for the safety of the subjects involved in this study, including, but not limited to the following: heart failure, uncontrolled or severe respiratory diseases,endocrine diseases, clinically relevant kidney or liver diseases or hematological diseases.
* Participation in any other clinical trial within 30 days (or 5 times the biological half-life of the research of the study product, whichever is longer) prior to the inclusion of the subject in this clinical trial.
* Patients with diseases or conditions that limit the use of adrenaline (heart disease, severe hypertension...)
* Severe psychiatric, psychological or neurological disorders
* Abuse of alcohol, drugs or medicines in the previous year.

Primary outcomes:
measure: Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.
timeFrame: Test sites should be inspected and recorded 15-20 min after application
Secondary outcomes:
Other outcomes:
Locations:
city: Denia
country: Spain
facility: Hospital de Denia (Marina Salud)
state: Alicante
city: La Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña (Hospital Abente y Lago)
Study officials:
References: