Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT)
Phase 3
Completed
- Conditions
- AllergyRhinoconjunctivitis
- Interventions
- Biological: Immunotherapy with modified extract of O. europaea pollen
- Registration Number
- NCT00537342
- Lead Sponsor
- Laboratorios Leti, S.L.
- Brief Summary
The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Olea europaea in the rhinitis or allergic rhinoconjunctivitis
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
Inclusion Criteria
- Positive suggestive clinical history of allergic seasonal rhinitis or rhinoconjunctivitis
- Patients of both gender > 18 years old
- Positive prick test results using non modified Olea europaea allergen extract (wheal size > 3mm2)
- Specific IgE to Olea europaea
- Written informed consent
Exclusion Criteria
- Use of immunotherapy during the last four years.
- Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:
- Treatment with ß-blockers
- Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
- Patients suffering from immune deficiencies
- Patients with serious psychiatric / psychological disturbances
- In addition, the following was considered as exclusion criteria:
- Pregnant or/ in lactation patients
- Patients aspirin intolerance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Immunotherapy with modified extract of O. europaea pollen Biological Vaccine B Immunotherapy with modified extract of O. europaea pollen -
- Primary Outcome Measures
Name Time Method Symptom score 1 year
- Secondary Outcome Measures
Name Time Method Dose-response skin prick-test 1 year Medication score 1 year Rhinoconjunctivitis quality of life questionnaire 1 year Analogical visual scale 1 year Serology 1 year Record of adverse events 1 year
Trial Locations
- Locations (1)
Hospital Universitatio Ciudad de Jaén
🇪🇸Jaén, Spain