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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier:
NCT00831025
First received: January 27, 2009
Last updated: November 8, 2013
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Rhinitis or Rhinoconjunctivitis (With or Without Asthma) Induced by Hypersensitivity to Olea Europea Pollen.
Biological: Immunotherapy with modified extract of Olea europaea pollen
Biological: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Laboratorios Leti, S.L.:

Primary Outcome Measures:
  • Symptoms and medication score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dose-response skin prick-test [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Medication score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Rhinoconjunctivitis quality of life questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Visual Analog Scales (VAS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Serology [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Symptoms score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Exhaled nitric oxide [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Adverse event [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 158
Study Start Date: January 2008
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831025

Locations
Spain
Hospital El Tomillar
Dos Hermanas, Sevilla, Spain, 41700
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004
Hospital Universitario San Cecilio
Granada, Spain, 18012
Complejo Hospitalario de Jaén
Jaén, Spain, 23007
Clínica Santa Isabel
Sevilla, Spain, 41018
Hospital Universitario Virgen Del Rocio
Sevilla, Spain, 41013
Hospital Virgen Macarena
Sevilla, Spain, 41071
Sponsors and Collaborators
Laboratorios Leti, S.L.
Investigators
Principal Investigator: Pedro Guardia, MD
  More Information

No publications provided

Responsible Party: Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier: NCT00831025     History of Changes
Other Study ID Numbers: 6018-PG-PSC-148, 2006-005727-41
Study First Received: January 27, 2009
Last Updated: November 8, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Laboratorios Leti, S.L.:
Immunotherapy
Allergoid
Depigmented
Polymerized
Allergen-extract
Rhinoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Hypersensitivity
Conjunctival Diseases
Eye Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 23, 2014