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

• Status: Completed
• Trial end date: 2018-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy; Istituto per la Ricerca e l'Innovazione Biomedica
• Treatments: Resveratrol

Criteria

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.