Biological standarization for allergenic extracts in patients with hipersensibility to extract MedDRA version: 20.0 Level: HLGT Classification code 10001708 Term: Allergic conditions System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Name: Phleum pratense
Pharmaceutical Form: Solution for skin-prick test
INN or Proposed INN: Phleum pratense
Other descriptive name: Phleum pratense
Concentration unit: mg/ml milligram(s)/mill
Sponsors
Diater, Laboratorio de Diagnóstico y Aplicaciones Terapéuticas S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The biological characterization of allergic extracts.;Secondary Objective: To determinate the specificity of extracts in patients with hipersensibility. 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Measuring the diameter of wheal and erythema produced by the study drug. 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 | — |
Countries
Spain
Contacts
Public ContactMedical Department
DIATER, Laboratorio de Diagnóstico y Aplicaciones Terapéuticas, S.A.
Outcome results
None listed