Biological standarization of pollen of Phleum pratense, Lolium perenne, Poa pratensis y Dactylis glomerata and its mixture to obtain extracts of these pollens with a potency provokes the same skin reaction in sensitive patients that the reaction the histamine produces in the subjects.

Phase 1

• Conditions: Biological standarization for allergenic extracts in patients with hipersensibility to extract; 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: EUCTR2019-002644-24-ES
• Lead Sponsor: Diater, Laboratorio de Diagnóstico y Aplicaciones Terapéuticas S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-02
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Informed consent signed and dated by patients/witness.
Age range between 18 and 65 years old for both sexs.
Positive case history with inhalant allergy to exposure to the allergen.
Positive diagnosis to the allergens by SPT
Specific IgE positive for any of the allergens
Negative pregnancy in urine 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 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who had received Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergens to be tested.
Use of drugs which may interfere with the skin reaction (antihistaminic drugs received in the previous 7 days, oral corticoids, tricyclic antidepressants, MAOI, beta blockers).
Pregnant women or breast feeding.
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, urticaria).
Patients treated with pimecrolimus and/or topic corticoids within the previous 21 days.
Immune system diseases clinically relevant.
Uncontrolled diseases severe that may increase the risk to the safety of patients participating in this study.
Patients with diseases or disorders that limit the use of adrenaline.
Patients with a history of serious reactions during the course of previous skin tests.
Patients who have received anti-IgE treatment (Omalizumab).
Patients participating in another clinical trial

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 allergic extracts.;Secondary Objective: To determinate the specificity of extracts in patients with hipersensibility.<br>Evaluate of the tolerability and safety of the extracts;Primary end point(s): Cutaneous reaction to the extracts;Timepoint(s) of evaluation of this end point: 30 minutes

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Measuring the diameter of wheal and erythema produced by the study drug.<br>Safety Assessment through documentation and monitoring of adverse events local and / or systemic that may arise in the course of the trial.;Timepoint(s) of evaluation of this end point: 30 minutes