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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Resveratrol nasal spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resveratrol nasal spray<br>2 sprays per nostril 3 times a day for a period of two months | Drug: Resveratrol nasal spray<br> <br> |
| Placebo Comparator: Placebo<br>2 sprays per nostril 3 times a day for a period of two months | Drug: Resveratrol nasal spray<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | two years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal obstruction, sneezing, itching, rhinorrhea, respiratory infections, wheezing