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

Leti Pharma

Status and phase

Completed

Phase 3

Conditions

Rhinoconjunctivitis

Allergy

Treatments

Biological: Immunotherapy with modified extract of O. europaea pollen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00537342

2006-001130-41

6018-PG-OSL-142 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

83 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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