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

Allergic Rhinitis Clinical Trial

— RENIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349619
• Other study ID #: 10/2017
• Status: Completed
• Phase: Phase 4
• Start date: March 5, 2018
• Est. completion date: July 31, 2018

Study information

• Verified date: December 2019
• Source: Istituto per la Ricerca e l'Innovazione Biomedica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Resveratrol plus Carboxymethyl-ß-Glucan
Patients in this arm will receive Resveratrol plus Carboxymethyl-ß-Glucan, two sprays (100µL/spray) per nostril three times/day for 4 weeks
• Placebo
Patients in this arm will receive nasal saline solution 0.9%, two sprays per nostril, three times/day for 4 weeks

Locations

Country	Name	City	State
Italy	Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal Interleukin-17 (IL-17)	IL-17 level at baseline	Baseline
Primary	Nasal Interleukin-23 (IL-23)	IL-23 level at baseline	Baseline
Primary	Nasal Interferon-? (INF-?)	INF-? level at baseline	Baseline
Primary	Nasal PH	Nasal PH at baseline	Baseline
Primary	Nasal Interleukin-5 (IL-5)	Mean change in IL-5 level from baseline to the end of treatment.	Baseline and 28 days
Secondary	Total 5 Symptom Score (T5SS)	Mean change in T5SS score from baseline to the end of treatment.	Baseline and 28 days
Secondary	Visual Analogue Scale for Rhinitis (VAS)	Mean change in VAS score from baseline to the end of treatment.	Baseline and 28 days
Secondary	Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)	Mean change in PRQLQ score from baseline to the end of treatment.	Baseline and 28 days
Secondary	Pittsburgh Sleep Quality Index (PSQI)	Mean change in PSQI score from baseline to the end of treatment.	Baseline and 28 days
Secondary	Nasal Exhaled Nitric Oxide (nNO)	Mean change of nNO from baseline to the end of treatment.	Baseline and 28 days
Secondary	Nasal Cytology	Mean change in nasal cytology counts from baseline to the end of treatment.	Baseline and 28 days
Secondary	Acoustic Rhinometry: Minimal Cross-sectional Area (MCA)	Mean change of MCA from baseline to the end of treatment.	Baseline and 28 days
Secondary	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