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

NCT02130440 | Completed Phase 3

• 1 other identifier: RESV_01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Keywords

nasal obstruction; sneezing; itching; rhinorrhea; respiratory infections; wheezing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Cough

  two years

• Wheezing

  two year

• Albuterol use

  two years

• Fever

  two years

• School absences

  two years

Study Arms (2)

Resveratrol nasal spray

ACTIVE COMPARATOR

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

Drug: Resveratrol nasal spray

Placebo

PLACEBO COMPARATOR

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

Drug: Resveratrol nasal spray

Interventions

Resveratrol nasal spray DRUG

Placebo; Resveratrol nasal spray

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Second University of Naples

Naples, Italy, Italy

Location

Related Publications (1)

• 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.

  PMID: 24983742 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Nasal Obstruction; Sneezing; Pruritus; Rhinorrhea; Respiratory Tract Infections; Respiratory Sounds

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Michele Miraglia del Giudice

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: May 5, 2014
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2014
• Last Updated: May 5, 2014

Record last verified: 2014-05

Locations

IT (1)