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Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica

NCT ID: NCT00916760

Last Updated: 2013-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Allergic Rhinoconjunctivitis

Keywords

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allergic, rhinoconjunctivitis, Immunotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

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

Group Type EXPERIMENTAL

Depigoid Parietaria judaica 1000DPP/ml

Intervention Type BIOLOGICAL

Subcutaneous monthly treatment

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Subcutaneous monthly treatment

Interventions

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Depigoid Parietaria judaica 1000DPP/ml

Subcutaneous monthly treatment

Intervention Type BIOLOGICAL

Placebo

Subcutaneous monthly treatment

Intervention Type BIOLOGICAL

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratorios Leti, S.L.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angel Ferrer, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospital Vega Baja

Locations

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H. Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Hospital Viladecans

Barcelona, Barcelona, Spain

Site Status

Hospital Vega Baja

Alicante, Orihuela, Spain

Site Status

H. de sagunto

Sagunto, Sagunto, Spain

Site Status

Hospital General de Onteniente

Ontinyent, Valencia, Spain

Site Status

Hospital Luis Alcañiz

Xàtiva, Valencia, Spain

Site Status

Hospital Marina Baixa

Alicante, , Spain

Site Status

Hospital de Castellón

Castellon, , Spain

Site Status

Hospital Reina Sofía

Murcia, , Spain

Site Status

Hospital Virgen de la Arrixaca

Murcia, , Spain

Site Status

Hospital La Fe

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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2006-005871-17

Identifier Type: -

Identifier Source: org_study_id