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

NCT ID: NCT00537342

Last Updated: 2010-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Allergy Rhinoconjunctivitis

Keywords

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Immunotherapy Allergoid Depigmented Polymerized Allergen-extract Rhinoconjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Biological Vaccine

Group Type EXPERIMENTAL

Immunotherapy with modified extract of O. europaea pollen

Intervention Type BIOLOGICAL

Sublingual (2 drops daily during 2 months)

B

Group Type PLACEBO_COMPARATOR

Immunotherapy with modified extract of O. europaea pollen

Intervention Type BIOLOGICAL

Sublingual (2 drops daily during 2 months)

Interventions

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Immunotherapy with modified extract of O. europaea pollen

Sublingual (2 drops daily during 2 months)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
* Pregnant or/ in lactation patients
* Patients aspirin intolerance
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratorios Leti, S.L.

INDUSTRY

Sponsor Role lead

Responsible Party

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Laboratorios LETI S.L.Unipersonal

Principal Investigators

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Juan Luis Anguita, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitatio Ciudad de Jaén

Jaén, Jaén, Spain

Site Status

Countries

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Spain

Other Identifiers

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6018-PG-OSL-142

Identifier Type: OTHER

Identifier Source: secondary_id

2006-001130-41

Identifier Type: -

Identifier Source: org_study_id