Single-center, randomized, placebo-controlled study to: * characterize the subjects at baseline and discriminate groups of children based on IL-5, IL-17, IL-23 and INF-γ; * investigate the effect of Resveratrol plus Carboxymethyl-β-Glucan, two sprays (100µL/spray) for nostril three times/day for 4 weeks, in comparison with placebo, in reducing nasal interleukin-5 (IL-5) in children with Allergic Rhinitis (AR). Secondary objectives are to examine the effect of resveratrol plus carboxymethyl-β-glucan, in comparison with placebo, on subjective parameters, i.e. symptom scores, visual analogue scales for rhinitis, quality of life and quality of sleep, and the effect on objective parameters, i.e. nasal nitric oxide (nNO) levels, nasal cytology and acoustic rhinometry.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Patients in this arm will receive Resveratrol plus Carboxymethyl-β-Glucan, two sprays (100µL/spray) per nostril three times/day for 4 weeks
Patients in this arm will receive nasal saline solution 0.9%, two sprays per nostril, three times/day for 4 weeks
Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo
Palermo, Italy
Nasal Interleukin-17 (IL-17)
IL-17 level at baseline
Time frame: Baseline
Nasal Interleukin-23 (IL-23)
IL-23 level at baseline
Time frame: Baseline
Nasal Interferon-γ (INF-γ)
INF-γ level at baseline
Time frame: Baseline
Nasal PH
Nasal PH at baseline
Time frame: Baseline
Nasal Interleukin-5 (IL-5)
Mean change in IL-5 level from baseline to the end of treatment.
Time frame: Baseline and 28 days
Total 5 Symptom Score (T5SS)
Mean change in T5SS score from baseline to the end of treatment.
Time frame: Baseline and 28 days
Visual Analogue Scale for Rhinitis (VAS)
Mean change in VAS score from baseline to the end of treatment.
Time frame: Baseline and 28 days
Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
Mean change in PRQLQ score from baseline to the end of treatment.
Time frame: Baseline and 28 days
Pittsburgh Sleep Quality Index (PSQI)
Mean change in PSQI score from baseline to the end of treatment.
Time frame: Baseline and 28 days
Nasal Exhaled Nitric Oxide (nNO)
Mean change of nNO from baseline to the end of treatment.
Time frame: Baseline and 28 days
Nasal Cytology
Mean change in nasal cytology counts from baseline to the end of treatment.
Time frame: Baseline and 28 days
Acoustic Rhinometry: Minimal Cross-sectional Area (MCA)
Mean change of MCA from baseline to the end of treatment.
Time frame: Baseline and 28 days
Acoustic Rhinometry: Nasal Volume from the first 5 cm from the nostril (V.0-5)
Mean change of V.0-5 from baseline to the end of treatment.
Time frame: Baseline and 28 days
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