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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
158
Subcutaneous immunotherapy with modified extract of Olea europaea. A subcutaneous monthly treatment.
Placebo for subcutaneous monthly administration
Hospital El Tomillar
Dos Hermanas, Sevilla, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Universitario San Cecilio
Granada, Spain
Complejo Hospitalario de Jaén
Jaén, Spain
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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Hospital Universitario Virgen Del Rocio
Seville, Spain
Clínica Santa Isabel
Seville, Spain
Hospital Virgen Macarena
Seville, Spain