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

NCT03349619 | Completed Phase 4

• 1 other identifier: 10/2017
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Total 5 Symptom Score (T5SS)

  Baseline and 28 days

• Visual Analogue Scale for Rhinitis (VAS)

  Baseline and 28 days

• Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)

  Baseline and 28 days

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline and 28 days

• Nasal Exhaled Nitric Oxide (nNO)

  Baseline and 28 days

Study Arms (2)

Resveratrol plus Carboxymethyl-β-Glucan

EXPERIMENTAL

Drug: Resveratrol plus Carboxymethyl-β-Glucan

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Resveratrol plus Carboxymethyl-β-Glucan DRUG

Patients in this arm will receive Resveratrol plus Carboxymethyl-β-Glucan, two sprays (100µL/spray) per nostril three times/day for 4 weeks

Resveratrol plus Carboxymethyl-β-Glucan

Placebo DRUG

Patients in this arm will receive nasal saline solution 0.9%, two sprays per nostril, three times/day for 4 weeks

Placebo

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• history of AR in the previous year;
• positive skin prick test to seasonal allergens.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo

Palermo, 90146, Italy

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 21, 2017
• Study Start: March 5, 2018
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: December 5, 2019

Record last verified: 2019-12

Locations

IT (1)