Trial | NCT00916760  Report issue

Title

Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica
Clinical, Multi-centre, Randomised, Double-blind Placebo-controlled Subcutaneous Immunotherapy Trial With Depigmented, Polymerized Extract of Parietaria Judaica Pollen on Patients With Hypersensitivity to This Pollen

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    153
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.
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.
Study Started
Feb 29
2008
Primary Completion
Feb 28
2013
Study Completion
Feb 28
2013
Last Update
Nov 11
2013
Estimate

Biological Depigoid Parietaria judaica 1000DPP/ml

Subcutaneous monthly treatment

  • Other names: A suspension of depigmented and glutaraldehyde-polymerised allergen extract of Parietaria judaica adsorbed onto aluminium hydroxide.

Biological Placebo

Subcutaneous monthly treatment

1 Experimental

A Subcutaneous Depigmented and Polymerized Allergen extract of Parietaria Judaica 1000 DPP/ml. Depigoid Parietaria judaica 1000 DPP/ml.

2 Placebo Comparator

Criteria 

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
No Results Posted