To determine the minimum amount of Alternaria alternata allergenextract producing a positive skin reaction.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Positive clinical history of inhalatory allergy to Alternaria alternata with (meaning: 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 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 Alternaria alternata 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 wheal area ? 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 alternaria alternata (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.
-The mean wheal diameters of the obtained with histamine dihydrochloride (10 mg / ml) in the forearm ? 3 mm.
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

Exclusion Criteria

-Immunotherapy in the past 5 years with an allergen preparation known
to interfere with the allergen to be tested (for example: fungal extracts)
-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, 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 1 or 2
-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

Secondary Outcome Measures

Name	Time	Method

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