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

University of Campania "Luigi Vanvitelli"

Status and phase

Completed

Phase 3

Conditions

Seasonal Allergic Rhinitis

Treatments

Drug: Resveratrol nasal spray

Study type

Interventional

Funder types

Other

Identifiers

NCT02130440

RESV_01

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

4 to 17 years old

Volunteers

No Healthy Volunteers

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