Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT)

December 16, 2010 updated by: Laboratorios Leti, S.L.

Prospective, Randomised, Double Blind, Placebo Controlled Study of Treatment With Sublingual Immunotherapy of Depigmented and Polymerised Allergen Extract of O. Europaea in Two Groups of Patients With Allergic Rhinitis /Rhinoconjunctivitis

The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Olea europaea in the rhinitis or allergic rhinoconjunctivitis

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)

83

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
      • Jaén, Spain, 23007
        • Hospital Universitatio Ciudad de Jaén

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:

  • Positive suggestive clinical history of allergic seasonal rhinitis or rhinoconjunctivitis
  • Patients of both gender > 18 years old
  • Positive prick test results using non modified Olea europaea allergen extract (wheal size > 3mm2)
  • Specific IgE to Olea europaea
  • Written informed consent

Exclusion Criteria:

  • Use of immunotherapy during the last four years.
  • Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:
  • Treatment with ß-blockers
  • Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
  • Patients suffering from immune deficiencies
  • Patients with serious psychiatric / psychological disturbances
  • In addition, the following was considered as exclusion criteria:
  • Pregnant or/ in lactation patients
  • Patients aspirin intolerance

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: B
Biological: Immunotherapy with modified extract of O. europaea pollen
Sublingual (2 drops daily during 2 months)
Experimental: A
Biological Vaccine
Biological: Immunotherapy with modified extract of O. europaea pollen
Sublingual (2 drops daily during 2 months)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptom score
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Dose-response skin prick-test
Time Frame: 1 year
1 year
Record of adverse events
Time Frame: 1 year
1 year
Medication score
Time Frame: 1 year
1 year
Rhinoconjunctivitis quality of life questionnaire
Time Frame: 1 year
1 year
Analogical visual scale
Time Frame: 1 year
1 year
Serology
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Laboratorios Leti, S.L.

Investigators

  • Principal Investigator: Juan Luis Anguita, MD

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

October 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 28, 2007

First Submitted That Met QC Criteria

September 28, 2007

First Posted (Estimate)

October 1, 2007

Study Record Updates

Last Update Posted (Estimate)

December 17, 2010

Last Update Submitted That Met QC Criteria

December 16, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-001130-41
  • 6018-PG-OSL-142 (Other Identifier: Sponsor protocol number)

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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