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

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

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.

Study Overview

• Status: Completed
• Conditions: Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen
• Intervention / Treatment: Biological: Immunotherapy with modified extract of Olea europaea pollen; Biological: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Granada, Spain, 18012
    • Hospital Universitario San Cecilio
  • Jaén, Spain, 23007
    • Complejo Hospitalario de Jaen
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Sevilla, Spain, 41071
    • Hospital Virgen Macarena
  • Sevilla, Spain, 41018
    • Clinica Santa Isabel
  • Sevilla
    • Dos Hermanas, Sevilla, Spain, 41700
      • Hospital El Tomillar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Depigmented and polymerized allergen extract of Olea europaea pollen for subcutaneous injection.	Biological: Immunotherapy with modified extract of Olea europaea pollen; Subcutaneous immunotherapy with modified extract of Olea europaea. A subcutaneous monthly treatment.
PLACEBO_COMPARATOR: 2; Placebo for subcutaneous injection.	Biological: Placebo; Placebo for subcutaneous monthly administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Symptoms and medication score	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse event	2 years
Symptoms score	2 years
Dose-response skin prick-test	2 years
Medication score	2 years
Rhinoconjunctivitis quality of life questionnaire	2 years
Visual Analog Scales (VAS)	2 years
Serology	2 years
Exhaled nitric oxide	2 years

Collaborators and Investigators

• Sponsor: Laboratorios Leti, S.L.
• Investigators: Principal Investigator: Pedro Guardia, MD

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: January 27, 2009
• First Submitted That Met QC Criteria: January 27, 2009
• First Posted (ESTIMATE): January 28, 2009

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Immunotherapy; Rhinoconjunctivitis; Allergoid; Depigmented; Polymerized; Allergen-extract
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Hypersensitivity; Rhinitis
• Other Study ID Numbers: 6018-PG-PSC-148; 2006-005727-41 (EUDRACT_NUMBER)