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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130440
• Other study ID #: RESV_01
• Status: Completed
• Phase: Phase 3
• First received: April 25, 2014
• Last updated: May 1, 2014
• Start date: November 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Second University of Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Resveratrol nasal spray

Locations

Country	Name	City	State
Italy	Second University of Naples	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Second University of Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Wheezing	Wheezing will be assessed using the same four-point scale and record by parents on a daily diary card.	two year	No
Secondary	Albuterol use	The albuterol use on demand will be record by parents on a daily diary card.	two years	No
Secondary	Fever	The days with fever will be record by parents on a daily diary card.	two years	No
Secondary	School absences	School absences will be record by a diary card.	two years	No
Secondary	Antihistamines use	Evaluation of Cetirizine syrup on-demand use will be record by parents on a diary card	two years	No
Secondary	Emergency visits	Emergency room visits for respiratory problems will be record by parents on a diary card.	two years	No