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

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

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 Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Resveratrol plus Carboxymethyl-β-Glucan; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Palermo, Italy, 90146
    • Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Patients in this arm will receive nasal saline solution 0.9%, two sprays per nostril, three times/day for 4 weeks
Experimental: Resveratrol plus Carboxymethyl-β-Glucan	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal Interleukin-17 (IL-17)	IL-17 level at baseline	Baseline
Nasal Interleukin-23 (IL-23)	IL-23 level at baseline	Baseline
Nasal Interferon-γ (INF-γ)	INF-γ level at baseline	Baseline
Nasal PH	Nasal PH at baseline	Baseline
Nasal Interleukin-5 (IL-5)	Mean change in IL-5 level from baseline to the end of treatment.	Baseline and 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total 5 Symptom Score (T5SS)	Mean change in T5SS score from baseline to the end of treatment.	Baseline and 28 days
Visual Analogue Scale for Rhinitis (VAS)	Mean change in VAS score from baseline to the end of treatment.	Baseline and 28 days
Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)	Mean change in PRQLQ score from baseline to the end of treatment.	Baseline and 28 days
Pittsburgh Sleep Quality Index (PSQI)	Mean change in PSQI score from baseline to the end of treatment.	Baseline and 28 days
Nasal Exhaled Nitric Oxide (nNO)	Mean change of nNO from baseline to the end of treatment.	Baseline and 28 days
Nasal Cytology	Mean change in nasal cytology counts from baseline to the end of treatment.	Baseline and 28 days
Acoustic Rhinometry: Minimal Cross-sectional Area (MCA)	Mean change of MCA from baseline to the end of treatment.	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.	Baseline and 28 days

Collaborators and Investigators

• Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2018
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Resveratrol
• Other Study ID Numbers: 10/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No