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
|
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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 |
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 |

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
|
- Symptoms and medication score [ Time Frame: 2 years ]
- Dose-response skin prick-test [ Time Frame: 2 years ]
- Medication score [ Time Frame: 2 years ]
- Rhinoconjunctivitis quality of life questionnaire [ Time Frame: 2 years ]
- Visual Analog Scales (VAS) [ Time Frame: 2 years ]
- Serology [ Time Frame: 2 years ]
- Symptoms score [ Time Frame: 2 years ]
- Exhaled nitric oxide [ Time Frame: 2 years ]
- Adverse event [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Pedro Guardia, MD |
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 |