Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica

Leti Pharma

Status and phase

Completed

Phase 3

Conditions

Allergic Rhinoconjunctivitis

Treatments

Biological: Depigoid Parietaria judaica 1000DPP/ml

Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00916760

2006-005871-17

Details and patient eligibility

About

The objective of this trial is to assess the clinical efficacy of the modified extract (depigmented and polymerized with glutaraldehyde) of the subcutaneous injection of Parietaria Judaica pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass pollen, evaluating the score regarding symptoms and consumption of the medication.

Full description

Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with two arms of treatment: placebo and active.

Enrollment

153 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed consent, signed by the subject
Positive clinical history of rhinitis/rhinoconjunctivitis allergy to Parietaria pollen
Patient of both gender aged from 18 up to 55
Diagnosed Sensitivity to Parietaria pollen base on:

Positive Nasal provocation test Positive prick test to P. Judaica Specific IgE to P.Judaica >0,7KU/L

Patients who are able to comply with the dose regime

Exclusion criteria

Relevant sensitivity to another perenne allergen
Patient with asthma
Use of immunotherapy during the last four years
Treatment with B. Blocking agents
Patient suffering from some pathology in which adrenaline was contraindicated
Subject suffers from a serious medical condition, which would interference the treatment and follow up of the subject in the study
Subject suffers from autoimmune disease(thyroiditis, lupus, etc.)
Conditions in which the patient can not offer full co-operation nad significant psychiatric disturbance.
Intolerance to aspirin
Pregnant women or with pregnancy risk and brest-feeding