Biological standardization of pollen of Phleum pratense, Olea europaea, mite extract Dermatophagoides pteronyssinus and animal allergen Felis domesticus.

Phase 1

Conditions: Biological standardization for allergenic extracts in patients with hipersensibility to extracts
MedDRA version: 20.0Level: HLGTClassification code 10001708Term: Allergic conditionsSystem Organ Class: 10021428 - Immune system disorders
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2012-005362-35-ES

Lead Sponsor: Instituto de Inmunología y Alergia INMUNAL SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Informed consent signed and dated by the patient/witness.
Patients living inan area where the allergen is considered as a relevant health problem.
Medical history supporting the allergy to the allergen.
Positive diagnosis to the allergen
Specific IgE positive for any of the allergens
Age range between 18 and 64 years old for both genders
Negative pregnancy test for fertile women
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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who had received previous immunotherapy within the previous 2 years
Patients who had received within the previous 15 day sany intake of drugs able to interfere in the Skin Prick test (e.g. anti histaminic, topic corticoids, ? blockers or tryciclic antidepresives).
Pregnant women or breast feeding
Patients who has received systemic corticoids (dose greater than 30 mg prednisone/day) for longer than a week.
Patients with cutaneous reactions which can modify the response (e.g. Dermographism, dermatitis, severe asthma, hipersensibility to phenol or any of the components of the prick test)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The biological characterization of allergen extracts;Secondary Objective: To determine the specificity of extracts in patients with hipersensibility.<br>To determine the optimal dose of the allergen extract on skin test.;Primary end point(s): Cutaneous reaction to the extract;Timepoint(s) of evaluation of this end point: 30 minutes

Secondary Outcome Measures