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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00537342

Enrollment

Registered

2007-10-01

Start date

2007-10-31

Completion date

2009-12-31

Last updated

2010-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy, Rhinoconjunctivitis

Keywords

Immunotherapy, Allergoid, Depigmented, Polymerized, Allergen-extract, Rhinoconjunctivitis

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.

Interventions

BIOLOGICALImmunotherapy with modified extract of O. europaea pollen

Sublingual (2 drops daily during 2 months)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
Symptom score	1 year

Secondary

Measure	Time frame
Medication score	1 year
Rhinoconjunctivitis quality of life questionnaire	1 year
Dose-response skin prick-test	1 year
Serology	1 year
Record of adverse events	1 year
Analogical visual scale	1 year

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026