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

Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537342
• Other study ID #: 2006-001130-41
• Secondary ID: 6018-PG-OSL-142
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2007
• Last updated: December 16, 2010
• Start date: October 2007
• Est. completion date: December 2009

Study information

• Verified date: December 2010
• Source: Laboratorios Leti, S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy
• Conjunctivitis
• Rhinoconjunctivitis

Intervention

Biological:
• Immunotherapy with modified extract of O. europaea pollen
Sublingual (2 drops daily during 2 months)

Locations

Country	Name	City	State
Spain	Hospital Universitatio Ciudad de Jaén	Jaén

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Leti, S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom score		1 year	No
Secondary	Dose-response skin prick-test		1 year	No
Secondary	Medication score		1 year	No
Secondary	Rhinoconjunctivitis quality of life questionnaire		1 year	No
Secondary	Analogical visual scale		1 year	No
Secondary	Serology		1 year	No
Secondary	Record of adverse events		1 year	Yes