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

Study Overview
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Brief Summary
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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.

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

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Resveratrol plus Carboxymethyl-β-Glucan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resveratrol plus Carboxymethyl-β-Glucan<br> | Drug: Resveratrol plus Carboxymethyl-β-Glucan<br>* Patients in this arm will receive Resveratrol plus Carboxymethyl-β-Glucan, two sprays (100µL/spray) per nostril three times/day for 4 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Patients in this arm will receive nasal saline solution 0.9%, two sprays per nostril, three times/day for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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