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

May 1, 2014 updated by: Prof. Michele Miraglia del Giudice, University of Campania "Luigi Vanvitelli"
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy
        • Second University of Naples

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
two years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESV_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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