The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Phleum pratense in the rhinoconjunctivitis and/or asthma of slight or moderate intensity, due to allergy to grass pollen.
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 three arms of treatment: placebo and two active (one of the active arms will receive a dose that is 10x the dose of the other arm).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Sublingual (2 drops daily)
Placebo 2 drops daily
Hospital Clínico de Salamanca
Salamanca, Salamanca, Spain
Symptom scores
Time frame: 1 year
Nasal provocation test
Time frame: 1 year
Dose-response skin prick-test
Time frame: 1 year
Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ)
Time frame: 1 year
Medication scores
Time frame: 1 year
Visual scales
Time frame: 1 year
"In vitro" immunological tests
Time frame: 1 year
Record of adverse events
Time frame: 1 year
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