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

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ClinicalTrials.gov Identifier: NCT00831025
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Laboratorios Leti, S.L.

Study Description
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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.

Condition or disease Intervention/treatment 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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2008
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Symptoms and medication score [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Dose-response skin prick-test [ Time Frame: 2 years ]
  2. Medication score [ Time Frame: 2 years ]
  3. Rhinoconjunctivitis quality of life questionnaire [ Time Frame: 2 years ]
  4. Visual Analog Scales (VAS) [ Time Frame: 2 years ]
  5. Serology [ Time Frame: 2 years ]
  6. Symptoms score [ Time Frame: 2 years ]
  7. Exhaled nitric oxide [ Time Frame: 2 years ]
  8. Adverse event [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Hospital Universitario Virgen Del Rocio
Sevilla, Spain, 41013
Clínica Santa Isabel
Sevilla, Spain, 41018
Hospital Virgen Macarena
Sevilla, Spain, 41071
Sponsors and Collaborators
Laboratorios Leti, S.L.
Investigators
Principal Investigator: Pedro Guardia, MD
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier: NCT00831025     History of Changes
Other Study ID Numbers: 6018-PG-PSC-148
2006-005727-41 ( EudraCT Number )
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

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

Additional relevant MeSH terms:
Rhinitis
Hypersensitivity
Conjunctivitis
Nose Diseases
Respiratory Tract Diseases
 Respiratory Tract Infections
Otorhinolaryngologic Diseases
Immune System Diseases
Conjunctival Diseases
Eye Diseases