Nebulized Resveratrol Plus Carboxymethyl-β-Glucan for Reducing IL-5 in Children With Allergic Rhinitis (RENIM)

Istituto per la Ricerca e l'Innovazione Biomedica

Status and phase

Completed

Phase 4

Conditions

Allergic Rhinitis

Treatments

Drug: Resveratrol plus Carboxymethyl-β-Glucan

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03349619

10/2017

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

history of AR in the previous year;
positive skin prick test to seasonal allergens.

Exclusion criteria

acute upper respiratory infections in the last 4 weeks;
lifetime history of asthma (doctor diagnosis);
use of nasal or oral corticosteroids, nasal or oral decongestants, antihistamines in the last 4 weeks;
anatomic nasal defects (ie, septum deviation), or nasal polyps;
active smoker.