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

This study has been completed.
Sponsor:
Information provided by:
Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier:
NCT00537342
First received: September 28, 2007
Last updated: December 16, 2010
Last verified: December 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Allergy
Rhinoconjunctivitis
 Biological: Immunotherapy with modified extract of O. europaea pollen
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Laboratorios Leti, S.L.:

Primary Outcome Measures:
  • Symptom score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dose-response skin prick-test [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Medication score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Rhinoconjunctivitis quality of life questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Analogical visual scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Serology [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Record of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 83
Study Start Date: October 2007
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Biological Vaccine
 Biological: Immunotherapy with modified extract of O. europaea pollen
Sublingual (2 drops daily during 2 months)
Placebo Comparator: B Biological: Immunotherapy with modified extract of O. europaea pollen
Sublingual (2 drops daily during 2 months)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00537342

Locations
Spain
Hospital Universitatio Ciudad de Jaén
Jaén, Spain, 23007
Sponsors and Collaborators
Laboratorios Leti, S.L.
Investigators
Principal Investigator: Juan Luis Anguita, MD
  More Information

No publications provided

Responsible Party: Mª José Gómez, Laboratorios LETI S.L.Unipersonal
ClinicalTrials.gov Identifier: NCT00537342     History of Changes
Other Study ID Numbers: 2006-001130-41, 6018-PG-OSL-142
Study First Received: September 28, 2007
Last Updated: December 16, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Laboratorios Leti, S.L.:
Immunotherapy
Allergoid
Depigmented
 Polymerized
Allergen-extract
Rhinoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013