Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica

November 8, 2013 updated by: Laboratorios Leti, S.L.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Hospital Marina Baixa
      • Barcelona, Spain, 08840
        • Hospital Viladecans
      • Castellón, Spain
        • Hospital de Castellón
      • Murcia, Spain
        • Hospital Reina Sofía
      • Murcia, Spain
        • Hospital Virgen de la Arrixaca
      • Sagunto, Spain, 46520
        • H. de Sagunto
      • Valencia, Spain
        • Hospital La Fe
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • H. Germans Trias i Pujol
    • Orihuela
      • Alicante, Orihuela, Spain, 03314
        • Hospital Vega Baja
    • Valencia
      • Onteniente, Valencia, Spain
        • Hospital General de Onteniente
      • Xativa, Valencia, Spain
        • Hospital Luis Alcañiz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Biological: Placebo
Subcutaneous monthly treatment
Experimental: 1
A Subcutaneous Depigmented and Polymerized Allergen extract of Parietaria Judaica 1000 DPP/ml. Depigoid Parietaria judaica 1000 DPP/ml.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptoms score
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Nasal Provocation test, Dose- response skin prick test, Quality of life questionnaire, visual scales, asthma symptom scores, Medication scores, adverse event and severity adverse event,unplanned healthcare resource utilization
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Leti, S.L.

Investigators

  • Principal Investigator: Angel Ferrer, Dr, Hospital Vega Baja

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (Estimate)

June 10, 2009

Study Record Updates

Last Update Posted (Estimate)

November 11, 2013

Last Update Submitted That Met QC Criteria

November 8, 2013

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-005871-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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