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

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.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Resveratrol nasal spray

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy
    • Second University of Naples

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"

Publications and helpful links

General Publications

• Miraglia Del Giudice M, Maiello N, Capristo C, Alterio E, Capasso M, Perrone L, Ciprandi G. Resveratrol plus carboxymethyl-beta-glucan reduces nasal symptoms in children with pollen-induced allergic rhinitis. Curr Med Res Opin. 2014 Oct;30(10):1931-5. doi: 10.1185/03007995.2014.938731. Epub 2014 Jul 7.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: April 25, 2014
• First Submitted That Met QC Criteria: May 1, 2014
• First Posted (Estimate): May 5, 2014

Study Record Updates

• Last Update Posted (Estimate): May 5, 2014
• Last Update Submitted That Met QC Criteria: May 1, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: wheezing; nasal obstruction; itching; sneezing; rhinorrhea; respiratory infections
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Resveratrol
• Other Study ID Numbers: RESV_01