To determine the minimum amount of Chenopodium album allergen extract producing a positive skin reaction.
- Conditions
- Allergy to Chenopodium albumMedDRA version: 15.0Level: LLTClassification code 10036019Term: Pollen allergySystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2012-001937-15-ES
- Lead Sponsor
- aboratorios Leti, S.L.Unipersonal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
-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.
-Positive skin prick test with a standardized commercially available preparation of chenopodium album 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 chenopodium album (CAP-RAST major or equal to 2). IgE results are valid if performed within oneyear prior to the inclusion of the subject in the study.
-Allergic symptoms during the pollen season of Chenopodium album.
-Medical history positive allergy inhalation (rhinitis and /or rhinoconjunctivitis and/or asthma) from Chenopodium album.
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 preparation known to interfere with the allergen to be tested.
-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: tricyclic or tetracyclic o IMAOs antidepressants,b-blockers or chronic use of corticosteroids or oral or use of corticoids both via oral or parenteral, in repeated patterns and intermittent (> 10 mg/día de 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.
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 Chenopodium album allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.;Secondary Objective: In this study there are no secondary objectives;Primary end point(s): Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.;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): No secondary endpoints in this study;Timepoint(s) of evaluation of this end point: Not applicable