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Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Olea Europaea Pollen (OLEA)

Primary Purpose

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

Status

Completed

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Immunotherapy with modified extract of Olea europaea pollen

Placebo

About this trial

This is an interventional treatment trial for Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen focused on measuring Immunotherapy, Allergoid, Depigmented, Polymerized, Allergen-extract, Rhinoconjunctivitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital El Tomillar
Hospital Universitario Reina Sofía
Hospital Universitario San Cecilio
Complejo Hospitalario de Jaén
Hospital Universitario Virgen Del Rocio
Clínica Santa Isabel
Hospital Virgen Macarena

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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

Placebo for subcutaneous injection.

Outcomes

Primary Outcome Measures

Symptoms and medication score

Secondary Outcome Measures

Dose-response skin prick-test

Medication score

Rhinoconjunctivitis quality of life questionnaire

Visual Analog Scales (VAS)

Serology

Symptoms score

Exhaled nitric oxide

Adverse event

Full Information

NCT ID

NCT00831025

First Posted

January 27, 2009

Last Updated

February 21, 2018

Sponsor

Laboratorios Leti, S.L.

1. Study Identification

Unique Protocol Identification Number

NCT00831025

Brief Title

Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Olea Europaea Pollen

Acronym

OLEA

Official Title

Multicenter, Randomised, Double-blind Placebo-controlled, Subcutaneous Immunotherapy Clinical Trial With Depigmented and Polymerized Allergen Extract of Olea Europaea Pollen in Patients With Hypersensitivity to Olea Pollen

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratorios Leti, S.L.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

158 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo for subcutaneous injection.

Intervention Type

Biological

Intervention Name(s)

Immunotherapy with modified extract of Olea europaea pollen

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Placebo for subcutaneous monthly administration

Primary Outcome Measure Information:

Title

Symptoms and medication score

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Dose-response skin prick-test

Time Frame

2 years

Title

Medication score

Time Frame

2 years

Title

Rhinoconjunctivitis quality of life questionnaire

Time Frame

2 years

Title

Visual Analog Scales (VAS)

Time Frame

2 years

Title

Serology

Time Frame

2 years

Title

Symptoms score

Time Frame

2 years

Title

Exhaled nitric oxide

Time Frame

2 years

Title

Adverse event

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pedro Guardia, MD

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital El Tomillar

City

Dos Hermanas

State/Province

Sevilla

ZIP/Postal Code

41700

Country

Spain

Facility Name

Hospital Universitario Reina Sofía

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Hospital Universitario San Cecilio

City

Granada

ZIP/Postal Code

18012

Country

Spain

Facility Name

Complejo Hospitalario de Jaén

City

Jaén

ZIP/Postal Code

23007

Country

Spain

Facility Name

Hospital Universitario Virgen Del Rocio

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Clínica Santa Isabel

City

Sevilla

ZIP/Postal Code

41018

Country

Spain

Facility Name

Hospital Virgen Macarena

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

12. IPD Sharing Statement

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Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Olea Europaea Pollen

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