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

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Resveratrol nasal spray
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seasonal Allergic Rhinitis focused on measuring nasal obstruction, sneezing, itching, rhinorrhea, respiratory infections, wheezing

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Second University of Naples

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Resveratrol nasal spray

Placebo

Arm Description

2 sprays per nostril 3 times a day for a period of two months

2 sprays per nostril 3 times a day for a period of two months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 25, 2014
Last Updated
May 1, 2014
Sponsor
University of Campania "Luigi Vanvitelli"
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1. Study Identification

Unique Protocol Identification Number
NCT02130440
Brief Title
Evaluation of the Beneficial Effects of a Nasal Spray of Resveratrol in Children With Seasonal Allergic Rhinitis
Official Title
Evaluation of the Beneficial Effects of a Nasal Spray of Resveratrol in Children With Seasonal Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
nasal obstruction, sneezing, itching, rhinorrhea, respiratory infections, wheezing

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resveratrol nasal spray
Arm Type
Active Comparator
Arm Description
2 sprays per nostril 3 times a day for a period of two months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 sprays per nostril 3 times a day for a period of two months
Intervention Type
Drug
Intervention Name(s)
Resveratrol nasal spray
Primary Outcome Measure Information:
Title
Nasal symptom severity
Description
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.
Time Frame
two years
Secondary Outcome Measure Information:
Title
Cough
Description
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.
Time Frame
two years
Title
Wheezing
Description
Wheezing will be assessed using the same four-point scale and record by parents on a daily diary card.
Time Frame
two year
Title
Albuterol use
Description
The albuterol use on demand will be record by parents on a daily diary card.
Time Frame
two years
Title
Fever
Description
The days with fever will be record by parents on a daily diary card.
Time Frame
two years
Title
School absences
Description
School absences will be record by a diary card.
Time Frame
two years
Title
Antihistamines use
Description
Evaluation of Cetirizine syrup on-demand use will be record by parents on a diary card
Time Frame
two years
Title
Emergency visits
Description
Emergency room visits for respiratory problems will be record by parents on a diary card.
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Second University of Naples
City
Naples
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24983742
Citation
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.
Results Reference
derived

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

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