Status:
COMPLETED
Biological Standardization of Dermatophagoides Pteronyssinus Allergen Extract
Lead Sponsor:
Laboratorios Leti, S.L.
Conditions:
Allergy Dermatophagoides Pteronyssinus
Allergic Rhinitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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 refere...
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 Dermatophag...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01821716
Start Date
March 1 2013
End Date
January 1 2014
Last Update
February 23 2018
Active Locations (2)
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1
Hospital de Denia (Marina Salud)
Denia, Alicante, Spain, 03700
2
Complexo Hospitalario Universitario A Coruña (Hospital Abente y Lago)
A Coruña, Spain, 15001