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

Laboratorios Leti, S.L.1 site in 1 country83 target enrollmentOctober 2007

ConditionsAllergy Rhinoconjunctivitis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Allergy
Sponsor: Laboratorios Leti, S.L.
Enrollment: 83
Locations: 1
Primary Endpoint: Symptom score
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

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.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

December 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Laboratorios Leti, S.L.

Eligibility 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