To determine the minimum amount of Artemisia vulgaris allergen extract producing a positive skin reaction.
- Conditions
- Allergy to Artermisia vulgarisMedDRA version: 14.1Level: LLTClassification code 10036019Term: Pollen allergySystem Organ Class: 100000004870Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2013-001310-15-ES
- Lead Sponsor
- ABORATORIOS LETI, S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Positive clinical history of inhalatory allergy to Artemisia vulgaris with (rhinitis and/or rhinoconjunctivitis and / or asthma)
-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 ethinic group
- Age ? 18 years and ? 60 years at the study inclusion day
- A positive prick test with a standardized commercially Artemisia vulgaris allergen extract (Wheal medium diameter ? 3mm or wheal area ? 7 mm2). The 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 Artemisia vulgaris (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.
- Allergy symptoms during the Artemisia vulgaris pollen season.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Immunotherapy in the past 5 years with an allergen extract Artemisia vulgaris or other allergen extract that may interfere with the allergene to be tested (for example: Helianthus annuus (sunflower) elatior Ambrosia eiator (ambrosia) or peach.
-Use of drugs that may interfere before and after with the skin reactions (for example: antihistamines). See appendix 1 of the protocol.
-Treatment with any of the following medications: oral tricyclic or tetracyclic
antidepressants, beta-blockers, corticosteroids (major 10 mg/daily of prednisone or equivalent).
- Women who are pregnant or breastfeeding period and women with positive pregnancy test at Visit 2, before skin 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.
-Subjects who have received anti-IgE (Omalizumab)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to assess the concentration of Artemisia vulgaris allergen extract that elictis a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.;Secondary Objective: The secondary objective is to perform the in vitro characterization of the internal reference preparation from subjects' serum, to determine their in vitro biological potency and to guarantee the cosistency of the biological potency of the product batch by batch;Primary end point(s): The wheal size area (mm2) which is produced on the skin after application of Artemisia vulgaris allergen extract at various concentrations, along with the wheal area induced by the positive control and the negative by Skin prick Test technique.;Timepoint(s) of evaluation of this end point: The primary endpoint will be determined after the last patient last visit (end of study)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The power of the PRI in vitro will determinate througth the implementation of inmunoassays, and shall be expressed in units of biolofical activity: <br>-Specific IgE.<br>-Competitive inhibition of specific IgE.;Timepoint(s) of evaluation of this end point: The secondary endpoint will be determined after the last patient last visit (end of study)