Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Olea Europaea Pollen
- Conditions
- Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen
- Interventions
- Biological: PlaceboBiological: Immunotherapy with modified extract of Olea europaea pollen
- Registration Number
- NCT00831025
- Lead Sponsor
- Laboratorios Leti, S.L.
- 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.
- 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
- 158
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo Placebo for subcutaneous injection. 1 Immunotherapy with modified extract of Olea europaea pollen Depigmented and polymerized allergen extract of Olea europaea pollen for subcutaneous injection.
- Primary Outcome Measures
Name Time Method Symptoms and medication score 2 years
- Secondary Outcome Measures
Name Time Method Exhaled nitric oxide 2 years Dose-response skin prick-test 2 years Visual Analog Scales (VAS) 2 years Serology 2 years Medication score 2 years Rhinoconjunctivitis quality of life questionnaire 2 years Symptoms score 2 years Adverse event 2 years
Trial Locations
- Locations (7)
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain
Clínica Santa Isabel
🇪🇸Sevilla, Spain
Hospital Universitario San Cecilio
🇪🇸Granada, Spain
Complejo Hospitalario de Jaén
🇪🇸Jaén, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
Hospital El Tomillar
🇪🇸Dos Hermanas, Sevilla, Spain