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

NCT ID: NCT03349619

Last Updated: 2019-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-05
• Study Completion Date: 2018-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Resveratrol plus Carboxymethyl-β-Glucan

Group Type: EXPERIMENTAL

Resveratrol plus Carboxymethyl-β-Glucan

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto per la Ricerca e l'Innovazione Biomedica

OTHER

Sponsor Role: lead

Responsible Party

Stefania La Grutta, MD

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.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Palermo, , Italy

Countries

Italy

Other Identifiers

10/2017

Identifier Type: -

Identifier Source: org_study_id