Nasal Resveratrol and Wheezing Episodes in Preschool Children

NCT04689412 | Completed

• 1 other identifier: RSV01Ped
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

As most of the upper airways infections (UAI) leading to wheezing are secondary to viral triggers, the possible antinflammatory and antiviral role of resveratrol has been suggested in several studies, both in vitro and in vivo. However, its efficacy has been studied only when evaluating upper respiratory symptoms. With the aim to define new approaches in patients with recurrent wheezing triggered by UAI we have performed a prospective observational study to evaluate the efficacy of a short-course of intranasal resveratrol, administered for 7 days at the beginning of UAI, when compared to standard nasal lavage with 0.9% saline solution, in terms of reduction in wheezing episodes.

Conditions

Wheezing; Upper Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Wheezing days

  number of wheezing days during the follow-up period

  october 2017 - march 2018

Secondary Outcomes (2)

• Severity index

  october 2017 - march 2018

• Severity index

  october 2017 - march 2018

Study Arms (2)

Cases

Children spontaneously treated with nasal resveratrol at the beginning of each upper airways infection

Drug: Resveratrol

Controls

Children spontaneously treated with nasal lavage at the beginning of each upper airways infection

Interventions

Resveratrol DRUG

Nasal administration of resveratrol

Cases

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients were selected from those referring to our centre for recurrent wheezing in the previous year.

You may qualify if:

• Presence of at least 8 episodes of wheezing in the previous October-March period
• Negative skin prick test (SPT) for the most common allergens.
• Age less than 6 years

You may not qualify if:

• Sensitization to food allergens
• Sensitization to perennial allergens or to tree pollen allergens.
• Presence of atopic dermatitis

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

Università di Perugia

Perugia, 06100, Italy

Location

MeSH Terms

Conditions

Respiratory Sounds; Respiratory Tract Infections

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Giuseppe Di Cara

Study Record Dates

• First Submitted: December 27, 2020
• First Posted: December 30, 2020
• Study Start: April 1, 2018
• Primary Completion: March 31, 2019
• Study Completion: April 30, 2019
• Last Updated: December 30, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)