Evaluation of the Beneficial Effects of a Nasal Spray of Resveratrol in Children With Seasonal Allergic Rhinitis

University of Campania Luigi Vanvitelli100 enrolled

Overview

The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe.

The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe. The primary objective is to assess whether the treatment with nasal spray based resveratrol is able to improve the allergic rhinitis symptoms during the two months of treatment. The secondary aim is to evaluate if the resveratrol nasal spray is able to reduce respiratory infections and wheezing episodes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

100

Conditions

Seasonal Allergic Rhinitis

Interventions

Resveratrol nasal sprayDRUG

Eligibility

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children of both sexes, ranging in age from 4 to 17 years * History of seasonal allergic rhinitis, mild, moderate or severe, defined according to the ARIA guidelines in 2010, documented by recurrent episodes in the previous year and confirmed by a positive skin test results * Written informed consent from at least one parent or a legal representative Exclusion Criteria: * Lack of informed consent in writing by at least one parent or a legal representative * Concomitant disorders, such as infection of the upper (sinusitis, etc..) or lower respiratory tract, nasal surgery in the last year, abnormalities of the respiratory tract, immune diseases * Use of antihistamines, nasal or systemic corticosteroids, leukotriene modifiers, cromolyn sodium, in the last six weeks

Locations (1)

Second University of Naples

Naples, Italy, Italy

Outcomes

Primary Outcomes

Nasal symptom severity

Nasal symptoms (itching, sneezing, rhinorrhea, and obstruction) will be scored by a four-point scale (0=no symptom; 1=mild; 2= moderate; 3= severe) and record by parents on a daily diary card.

Time frame: two years

Secondary Outcomes

Cough

The cough presence and severity will be assessed during the day and the night by four-point scale and recorded by parents on a daily diary card.

Time frame: two years

Wheezing

Wheezing will be assessed using the same four-point scale and record by parents on a daily diary card.

Time frame: two year

Albuterol use

The albuterol use on demand will be record by parents on a daily diary card.

Time frame: two years

Fever

The days with fever will be record by parents on a daily diary card.

Time frame: two years

School absences

School absences will be record by a diary card.

Time frame: two years

Antihistamines use

Evaluation of Cetirizine syrup on-demand use will be record by parents on a diary card

Time frame: two years

Emergency visits

Emergency room visits for respiratory problems will be record by parents on a diary card.

Time frame: two years

Data from ClinicalTrials.gov

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