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

Phase 4

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: Resveratrol plus Carboxymethyl-β-Glucan; Drug: Placebo

• Registration Number: NCT03349619
• Lead Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-21
• Study Start: 2018-03-05
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resveratrol plus Carboxymethyl-β-Glucan	Resveratrol plus Carboxymethyl-β-Glucan	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Total 5 Symptom Score (T5SS)	Baseline and 28 days	Mean change in T5SS score from baseline to the end of treatment.
Visual Analogue Scale for Rhinitis (VAS)	Baseline and 28 days	Mean change in VAS score from baseline to the end of treatment.
Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)	Baseline and 28 days	Mean change in PRQLQ score from baseline to the end of treatment.
Pittsburgh Sleep Quality Index (PSQI)	Baseline and 28 days	Mean change in PSQI score from baseline to the end of treatment.
Nasal Exhaled Nitric Oxide (nNO)	Baseline and 28 days	Mean change of nNO from baseline to the end of treatment.
Nasal Cytology	Baseline and 28 days	Mean change in nasal cytology counts from baseline to the end of treatment.
Acoustic Rhinometry: Minimal Cross-sectional Area (MCA)	Baseline and 28 days	Mean change of MCA from baseline to the end of treatment.
Acoustic Rhinometry: Nasal Volume from the first 5 cm from the nostril (V.0-5)	Baseline and 28 days	Mean change of V.0-5 from baseline to the end of treatment.

Trial Locations

Locations (1)

Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo; 🇮🇹 Palermo, Italy