Biological standardization of allergen extracts of pollen of Artemisa vulgaris and Platanus acerifolia and the acarus Dermatophagoides farinae in patients sensitized to them.

Bial Industrial Farmacéutica S.A.0 个研究点开始时间: 2012年6月26日最近更新: 2012年11月19日

适应症

试验速览

暂无简介。

•1. History consistent with the allergen to be tested.
•2. Subject monosensitized, or clinically relevant sensitization to allergen test only, or primary sensitization (maximum skin reactivity and IgE) to the allergen in question.
•3. Wheal diameter to histamine 10 mg / ml ? 3 mm.
•4. Age: 18-60 years.
•5. Signed written informed consent.
•6. Environment correlated with the allergen.
•7. Women of childbearing age must submit a urine pregnancy test with negative result at the time of his entering the study
•Atopic subjects: wheal diameter <3 mm for the pollen of Artemisa vulgaris, Platanus acerifolia and / or Dermatophagoides farinae or other allergens that cross-reactivity with him.
•Nonatopic subjects: No wheal or papule with a diameter <3 mm for all allergens tested in the baseline visit
•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 165
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Allergen-specific immunotheraphy in the last 5 years with Artemisa vulgaris and/or Platanus acerifolia and/or Dermatophagoides farinae.
•2. Administration of medication that may interfere with the performance or results of testing (prick test).
•3. Patients with clinical history of anaphylaxis
•4. Patients with chronic urticaria
•5. Patients with atopic dermatitis moderate to severe
•6. Any medical condition that contraindicates the performance of skin testing by prick test.
•7. Pregnant or lactating women.
•8. Subjects who participated in another clinical trial 3 months before.

发起方

Bial Industrial Farmacéutica S.A.