The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with Olea europaea pollen extract in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity
An study conducted througout Spain with 4000 allergic patients (Alergoloógica 2005) showed that 47% of patients with rhinoconjuncitivits and 51% of asthmatic patients were sentitized to olive pollen. This gives us an idea of the importance of this allergen sensitization in Spain.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Subcutaneous immunotherapy in depot presentation in a rapid dose escalation scheme: 6 weekly increasing dose injections at the initiation phase plus 3 maintenance monthly injections.
Complejo Hospitalario de Jaén
Jaén, Andalusia, Spain
Hospital Santa Bárbara
Puertollano, Ciudad Real, Spain
Hospital Infanta Cristina
Badajoz, Spain
Hospital Costa de la Luz
Huelva, Spain
Hospital Nisar Sevilla
Number and severity of adverse reactions as a measure of Safety and tolerability
Time frame: 17 weeks treatment period
Immunoglobulin changes from baseline
Time frame: At baseline and 1 week after last administered dose
Cutaneous reactivity changes from baseline
Skin prick test will be conducted at baseline and 1 week after last administered dose to measure the wheal área changes in mm2
Time frame: At baseline and 1 week after last administered dose
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Seville, Spain