Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Olea Europaea Pollen (OLEA)
This study is ongoing, but not recruiting participants.
Sponsor:
Laboratorios Leti, S.L.
Information provided by:
Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier:
NCT00831025
First received: January 27, 2009
Last updated: August 10, 2011
Last verified: August 2011
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Purpose
Detailed Description:
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 ]
Estimated Enrollment: | 150 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (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
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 | |
Hospital Universitario Virgen Del Rocio | |
Sevilla, Spain, 41013 | |
Hospital Virgen Macarena | |
Sevilla, Spain, 41071 | |
Clínica Santa Isabel | |
Sevilla, Spain, 41018 |
Sponsors and Collaborators
Laboratorios Leti, S.L.
Investigators
Principal Investigator: | Pedro Guardia, MD |
More Information
No publications provided
Keywords provided by Laboratorios Leti, S.L.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 18, 2012
No publications provided
Responsible Party: | María José Gómez / Clinical Development Manager, Laboratorios LETI S.L.Unipersonal |
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: | August 10, 2011 |
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:
Hypersensitivity Rhinitis Conjunctivitis Immune System Diseases Nose Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Conjunctival Diseases Eye Diseases |
ClinicalTrials.gov processed this record on October 18, 2012