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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Resveratrol plus Carboxymethyl-β-Glucan
Placebo
Sponsored by
Istituto per la Ricerca e l'Innovazione Biomedica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Resveratrol plus Carboxymethyl-β-Glucan

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Nasal Interleukin-17 (IL-17)
IL-17 level at baseline
Nasal Interleukin-23 (IL-23)
IL-23 level at baseline
Nasal Interferon-γ (INF-γ)
INF-γ level at baseline
Nasal PH
Nasal PH at baseline
Nasal Interleukin-5 (IL-5)
Mean change in IL-5 level from baseline to the end of treatment.

Secondary Outcome Measures

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

Full Information

First Posted
November 17, 2017
Last Updated
December 3, 2019
Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
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1. Study Identification

Unique Protocol Identification Number
NCT03349619
Brief Title
Nebulized Resveratrol Plus Carboxymethyl-β-Glucan for Reducing IL-5 in Children With Allergic Rhinitis
Acronym
RENIM
Official Title
ReNIM Study - Nebulized Resveratrol Plus Carboxymethyl-β-Glucan for Reducing Nasal Interleukin-5 (IL-5) Measurements in Children With Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resveratrol plus Carboxymethyl-β-Glucan
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Resveratrol plus Carboxymethyl-β-Glucan
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Patients in this arm will receive nasal saline solution 0.9%, two sprays per nostril, three times/day for 4 weeks
Primary Outcome Measure Information:
Title
Nasal Interleukin-17 (IL-17)
Description
IL-17 level at baseline
Time Frame
Baseline
Title
Nasal Interleukin-23 (IL-23)
Description
IL-23 level at baseline
Time Frame
Baseline
Title
Nasal Interferon-γ (INF-γ)
Description
INF-γ level at baseline
Time Frame
Baseline
Title
Nasal PH
Description
Nasal PH at baseline
Time Frame
Baseline
Title
Nasal Interleukin-5 (IL-5)
Description
Mean change in IL-5 level from baseline to the end of treatment.
Time Frame
Baseline and 28 days
Secondary Outcome Measure Information:
Title
Total 5 Symptom Score (T5SS)
Description
Mean change in T5SS score from baseline to the end of treatment.
Time Frame
Baseline and 28 days
Title
Visual Analogue Scale for Rhinitis (VAS)
Description
Mean change in VAS score from baseline to the end of treatment.
Time Frame
Baseline and 28 days
Title
Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
Description
Mean change in PRQLQ score from baseline to the end of treatment.
Time Frame
Baseline and 28 days
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Mean change in PSQI score from baseline to the end of treatment.
Time Frame
Baseline and 28 days
Title
Nasal Exhaled Nitric Oxide (nNO)
Description
Mean change of nNO from baseline to the end of treatment.
Time Frame
Baseline and 28 days
Title
Nasal Cytology
Description
Mean change in nasal cytology counts from baseline to the end of treatment.
Time Frame
Baseline and 28 days
Title
Acoustic Rhinometry: Minimal Cross-sectional Area (MCA)
Description
Mean change of MCA from baseline to the end of treatment.
Time Frame
Baseline and 28 days
Title
Acoustic Rhinometry: Nasal Volume from the first 5 cm from the nostril (V.0-5)
Description
Mean change of V.0-5 from baseline to the end of treatment.
Time Frame
Baseline and 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo
City
Palermo
ZIP/Postal Code
90146
Country
Italy

12. IPD Sharing Statement

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

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