Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT) - Full Text View

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 III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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: One 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 ]

Enrollment:	30
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Biological: Immunotherapy with modified extract of O europaea pollen Sublingual (2 drops daily during 2 months)
B: Placebo Comparator	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 and older
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	Unaffiliated

More Information

Responsible Party:	Laboratorios LETI S.L.Unipersonal ( María José Gómez )
Study ID Numbers:	2006-001130-41, 6018-PG-OSL-142
First Received:	September 28, 2007
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00537342
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Laboratorios Leti, S.L.:

Immunotherapy

Allergoid

Depigmented

Polymerized

Allergen-extract

Rhinoconjunctivitis

Study placed in the following topic categories:

Hypersensitivity

Hypersensitivity, Immediate

Rhinitis

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Laboratorios Leti, S.L.
Information provided by:	Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier:	NCT00537342