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

• Conditions: Treatment and diagnosis of allergy to Artemisa vulgaris, Platanus acerifolia and Dermatophagoides farinae.; MedDRA version: 14.1Level: LLTClassification code 10036019Term: Pollen allergySystem Organ Class: 10021428 - Immune system disorders; MedDRA version: 14.1Level: LLTClassification code 10066092Term: Acaridae allergySystem Organ Class: 10021428 - Immune system disorders; MedDRA version: 14.1Level: PTClassification code 10048908Term: Seasonal allergySystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-000672-42-ES
• Lead Sponsor: Bial Industrial Farmacéutica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-26
• Last Update Posted: 19 November 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In-vivo determination of the biological activity of pollen extracts of Artemisa vulgaris, Platanus acerifoia and Dermatophagoides farinae.;Secondary Objective: In-vivo determination of the biological activity of pollen extracts of Artemisa vulgaris, Platanus acerifoia and Dermatophagoides farinae.;Primary end point(s): Planimetry:<br>The size of the wheal was calculated by planimetry in Bial SA Pharmaceutical Industry and measured in units of mm2. The test is considered positive if the wheal diameter is 3mm, if the diameter is <3 mm the test is considered negative.;Timepoint(s) of evaluation of this end point: 15 minutes after prick test

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A