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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014