Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Olea Europaea Pollen

NCT ID: NCT00831025

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2013-01-31

Brief Summary

The objective of this trial is to assess the clinical efficacy of a modified allergen extract of Olea europaea pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis (with or without episodic asthma) induced by hypersensitivity to olea europaea pollen, evaluating the Score regarding Symptoms and consumption of the medication.

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.

Conditions

Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Depigmented and polymerized allergen extract of Olea europaea pollen for subcutaneous injection.

Group Type: EXPERIMENTAL

Immunotherapy with modified extract of Olea europaea pollen

Intervention Type: BIOLOGICAL

Subcutaneous immunotherapy with modified extract of Olea europaea. A subcutaneous monthly treatment.

2

Placebo for subcutaneous injection.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo for subcutaneous monthly administration

Interventions

Immunotherapy with modified extract of Olea europaea pollen

Subcutaneous immunotherapy with modified extract of Olea europaea. A subcutaneous monthly treatment.

Intervention Type: BIOLOGICAL

Placebo

Placebo for subcutaneous monthly administration

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Prior to study specific examinations the patient and if applicable both legal guardians has to give his/her written informed consent
• Patients of both gender aged from 18 and 55 years
• Patient's perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS)
• FEV1 greater or equal than 80% of the expected value, and if not, improvement of FEV1 greater than 12% after bronchodilation
• Patients have to suffer from allergic complaints (rhinitis and/or rhinoconjunctivitis with or without mild intermittent allergic asthma) caused by clinical sensitization against Olea europaea pollen. The IgE mediated sensitization has to be verified by:
• Suggestive medical history
• Specific IgE against Olea europaea pollen CAP RAST ≥0.7Ku/l
• Positive skin prick test (SPT) to grass Olea pollen resulting in a wheal diameter of at least 3 mm.

Exclusion Criteria

• History of significant clinical manifestations of allergy as a result of sensitization against weed pollen allergens and perennial (e.g. house dust mite.
• Participation in an immunotherapy with comparable extracts within the last five years.
• Treatment with β-blocker
• Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism)
• Cardiovascular insufficiency or any severe or unstable pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant
• Immunopathological diseases
• Patients who are expected to be non-compliant and/or not co-operative
• Women, where pregnancy is defined as the state of a female after conception and until the termination of gestation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorios Leti, S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pedro Guardia, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital El Tomillar

Dos Hermanas, Sevilla, Spain

Hospital Universitario Reina Sofía

Córdoba, , Spain

Hospital Universitario San Cecilio

Granada, , Spain

Complejo Hospitalario de Jaén

Jaén, , Spain

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Clínica Santa Isabel

Seville, , Spain

Hospital Virgen Macarena

Seville, , Spain

Countries

Spain

Other Identifiers

2006-005727-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

6018-PG-PSC-148

Identifier Type: -

Identifier Source: org_study_id