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

Phase 3

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: Resveratrol nasal spray

• Registration Number: NCT02130440
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2012-11
• Primary Completion: 2013-12
• Study Completion: 2014-04
• Study First Submitted: 2014-04-25
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-01
• Last Update Submitted: 2014-05-01
• Study First Posted: 2014-05-05
• Last Update Posted: 2014-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resveratrol nasal spray	Resveratrol nasal spray	2 sprays per nostril 3 times a day for a period of two months
Placebo	Resveratrol nasal spray	2 sprays per nostril 3 times a day for a period of two months

Primary Outcome Measures

Name	Time	Method
Nasal symptom severity	two years	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.

Secondary Outcome Measures

Name	Time	Method
Cough	two years	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.
Wheezing	two year	Wheezing will be assessed using the same four-point scale and record by parents on a daily diary card.
Albuterol use	two years	The albuterol use on demand will be record by parents on a daily diary card.
Fever	two years	The days with fever will be record by parents on a daily diary card.
School absences	two years	School absences will be record by a diary card.
Antihistamines use	two years	Evaluation of Cetirizine syrup on-demand use will be record by parents on a diary card
Emergency visits	two years	Emergency room visits for respiratory problems will be record by parents on a diary card.

Trial Locations

Locations (1)

Second University of Naples; 🇮🇹 Naples, Italy