The purpose of this study is evaluate the efficacy of a depigmented grass extract in the treatment of local allergic rhinitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
Subcutaneous Immunotherapy with modified extract of Phleum pollen.
Placebo for subcutaneous administration
Hospital Infanta Leonor
Madrid, Madrid, Spain
Hospital Regional Universitario Carlos Haya
Málaga, Malaga, Spain
Symptoms and medication scores comparison between active and placebo group
Patients were provided a diary to score the severity of their symptoms and the use of rescue medication during 4 weeks in two consecutive springs. Nasal symptoms of rhinorrhea, nasal congestion, sneezing, nasal itching, and ocular symptoms were recorded using a 4-point categorical scale from 0 to 3 (0: no symptoms, 1:mild, 2:moderate; 3:severe). The use of rescue medication was recorded in the patient diary according to the following score: Oral antihistamines (1 tablet = 1 point); intranasal corticosteroids (400mcg/day of beclometasone or equivalent = 1.4 points); and ocular antihistamines (1 dose = 1 point).
Time frame: two years
Response to nasal allergen provocation test with phleum (NAPT-Phl)
The response to NAPT-Phl with increasing concentrations of phleum pratense (0.001-0.01-0.05-0.1 mcg/ml) will be evaluated by nasal symptoms and acoustic rhinometry.
Time frame: two years
Skin prick-test (SPT) with phleum.
Evaluation of SPT wheal size.
Time frame: 2 years
Intradermal test (IDT) with phleum
IDT wheal and erythema size.
Time frame: 2 years
FEV1
Time frame: 2 years
Quality of life questionnaire RQLQ
Time frame: 2 years
Flow cytometry study for determination of IFN-gamma, IL-13, IL-5, IL-8, IL-10, IL-12, IL-2 in peripheral blood and nasal lavage
Time frame: 2 years
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Determination of tryptase, eosinophil cationic protein, IgG, IgG4, specific IgE to grass (Phl p1, Phl p5, Phl p7, Phl p12) in peripheral blood and nasal lavage.
Time frame: 2 years
Heart rate
Time frame: 2 years
Blood pressure
Time frame: 2 years
Adverse events
Time frame: 2 years