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Completed

NCT Number: NCT03349619

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

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.

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Key information

Conditions

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

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Palermo, 90146, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Placebo

Drug

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

Primary outcomes

  1. Nasal Interleukin-17 (IL-17)

    Time frame: Baseline

    IL-17 level at baseline

  2. Nasal Interleukin-23 (IL-23)

    Time frame: Baseline

    IL-23 level at baseline

  3. Nasal Interferon-γ (INF-γ)

    Time frame: Baseline

    INF-γ level at baseline

  4. Nasal PH

    Time frame: Baseline

    Nasal PH at baseline

  5. Nasal Interleukin-5 (IL-5)

    Time frame: Baseline and 28 days

    Mean change in IL-5 level from baseline to the end of treatment.

Secondary outcomes

  1. Total 5 Symptom Score (T5SS)

    Time frame: Baseline and 28 days

    Mean change in T5SS score from baseline to the end of treatment.

  2. Visual Analogue Scale for Rhinitis (VAS)

    Time frame: Baseline and 28 days

    Mean change in VAS score from baseline to the end of treatment.

  3. Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)

    Time frame: Baseline and 28 days

    Mean change in PRQLQ score from baseline to the end of treatment.

  4. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and 28 days

    Mean change in PSQI score from baseline to the end of treatment.

  5. Nasal Exhaled Nitric Oxide (nNO)

    Time frame: Baseline and 28 days

    Mean change of nNO from baseline to the end of treatment.

  6. Nasal Cytology

    Time frame: Baseline and 28 days

    Mean change in nasal cytology counts from baseline to the end of treatment.

  7. Acoustic Rhinometry: Minimal Cross-sectional Area (MCA)

    Time frame: Baseline and 28 days

    Mean change of MCA from baseline to the end of treatment.

  8. Acoustic Rhinometry: Nasal Volume from the first 5 cm from the nostril (V.0-5)

    Time frame: Baseline and 28 days

    Mean change of V.0-5 from baseline to the end of treatment.

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Registry information

Official study title

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

Acronym: RENIM

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 21, 2017
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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