NCT03349619

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

ReNIM Study - Nebulized Resveratrol Plus Carboxymethyl-β-Glucan for Reducing Nasal Interleukin-5 (IL-5) Measurements in Children With Allergic Rhinitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Resveratrol plus Carboxymethyl-β-Glucan	Patients in this arm will receive Resveratrol plus Carboxymethyl-β-Glucan, two sprays (100µL/spray) per nostril three times/day for 4 weeks
DRUG	Placebo	Patients in this arm will receive nasal saline solution 0.9%, two sprays per nostril, three times/day for 4 weeks

Timeline

• Start date: 2018-03-05
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2017-11-21
• Last updated: 2019-12-05

Locations

1 site across 1 country: Italy