NCT00831025
Completed
Phase 3
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
Laboratorios Leti, S.L.7 sites in 1 country158 target enrollmentStarted: January 2008Last updated:
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Laboratorios Leti, S.L.
- Enrollment
- 158
- Locations
- 7
- Primary Endpoint
- Symptoms and medication score
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- 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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Symptoms and medication score
Time Frame: 2 years
Secondary Outcomes
- Visual Analog Scales (VAS)(2 years)
- Serology(2 years)
- Exhaled nitric oxide(2 years)
- Dose-response skin prick-test(2 years)
- Medication score(2 years)
- Rhinoconjunctivitis quality of life questionnaire(2 years)
- Symptoms score(2 years)
- Adverse event(2 years)
Investigators
Study Sites (7)
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