Allergic Rhinitis
Conditions
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.
Interventions
DRUGResveratrol 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
DRUGPlacebo
Patients in this arm will receive nasal saline solution 0.9%, two sprays per nostril, three times/day for 4 weeks
Sponsors
Istituto per la Ricerca e l'Innovazione Biomedica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Interleukin-17 (IL-17) | Baseline | IL-17 level at baseline |
| Nasal Interleukin-23 (IL-23) | Baseline | IL-23 level at baseline |
| Nasal Interferon-γ (INF-γ) | Baseline | INF-γ level at baseline |
| Nasal PH | Baseline | Nasal PH at baseline |
| Nasal Interleukin-5 (IL-5) | Baseline and 28 days | Mean change in IL-5 level from baseline to the end of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Cytology | Baseline and 28 days | Mean change in nasal cytology counts from baseline to the end of treatment. |
| Total 5 Symptom Score (T5SS) | Baseline and 28 days | Mean change in T5SS score from baseline to the end of treatment. |
| Acoustic Rhinometry: Nasal Volume from the first 5 cm from the nostril (V.0-5) | Baseline and 28 days | Mean change of V.0-5 from baseline to the end of treatment. |
| Acoustic Rhinometry: Minimal Cross-sectional Area (MCA) | Baseline and 28 days | Mean change of MCA from baseline to the end of treatment. |
| Visual Analogue Scale for Rhinitis (VAS) | Baseline and 28 days | Mean change in VAS score from baseline to the end of treatment. |
| Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) | Baseline and 28 days | Mean change in PRQLQ score from baseline to the end of treatment. |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline and 28 days | Mean change in PSQI score from baseline to the end of treatment. |
| Nasal Exhaled Nitric Oxide (nNO) | Baseline and 28 days | Mean change of nNO from baseline to the end of treatment. |
Countries
Italy
Outcome results
None listed