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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00537342
Recruitment Status : Completed
First Posted : October 1, 2007
Last Update Posted : December 17, 2010
Information provided by:
Laboratorios Leti, S.L.

Brief Summary:
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 or disease Intervention/treatment Phase
Allergy Rhinoconjunctivitis Biological: Immunotherapy with modified extract of O. europaea pollen Phase 3

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  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Symptom score [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Dose-response skin prick-test [ Time Frame: 1 year ]
  2. Medication score [ Time Frame: 1 year ]
  3. Rhinoconjunctivitis quality of life questionnaire [ Time Frame: 1 year ]
  4. Analogical visual scale [ Time Frame: 1 year ]
  5. Serology [ Time Frame: 1 year ]
  6. Record of adverse events [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00537342

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

Responsible Party: Mª José Gómez, Laboratorios LETI S.L.Unipersonal Identifier: NCT00537342     History of Changes
Other Study ID Numbers: 2006-001130-41
6018-PG-OSL-142 ( Other Identifier: Sponsor protocol number )
First Posted: October 1, 2007    Key Record Dates
Last Update Posted: December 17, 2010
Last Verified: December 2010

Keywords provided by Laboratorios Leti, S.L.:

Additional relevant MeSH terms:
Conjunctival Diseases
Eye Diseases