NCT05684848

Brief Summary

To determine whether or not preventive administration of resveratrol in the form of a nasal spray is effective in reducing the number of asthma exacerbations typical of preschool wheezing children who develop viral infections.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

January 5, 2023

Last Update Submit

January 13, 2023

Conditions

WheezingRecurrent Respiratory Tract Infections

Keywords

RRIWheezingMedical DeviceResveratrol

Outcome Measures

Primary Outcomes (1)

  • Change of the number of days with respiratory symptoms compared to placebo

    To determine whether taking resveratrol in the form of a nasal spray changes the number of days with respiratory symptoms compared to placebo.

    3 months

Secondary Outcomes (1)

  • In case of exacerbations, verify the change in the number of respiratory exacerbations and their duration of the group treated with resveratrol in the form of nasal spray vs the control group.

    3 months

Study Arms (2)

Resveratrol + CMG

ACTIVE COMPARATOR

Medical device: nasal spray based on resveratrol associated with carboxymethylbetaglucan in isotonic solution

Device: Resveratrol + CMG

Isotonic solution

PLACEBO COMPARATOR

Medical Device with isotonic solution

Device: Isotonic solution

Interventions

Resveratrol + CMGDEVICE

As prevention (resveratrol or its placebo) 2 puffs per nostril 2 times a day (morning and evening) for a period of 3 months. If during the preventive administration of the spray the first symptoms of a viral infection should appear, the parent should increase the dosage of the nasal spray to 2 puffs per nostril 4 times a day.

Resveratrol + CMG
Isotonic solutionDEVICE

As prevention (resveratrol or its placebo) 2 puffs per nostril 2 times a day (morning and evening) for a period of 3 months. If during the preventive administration of the spray the first symptoms of a viral infection should appear, the parent should increase the dosage of the nasal spray to 2 puffs per nostril 4 times a day.

Isotonic solution

Eligibility Criteria

Age3 Years - 6 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children diagnosed with wheezing
  • Patients aged between 3 and 6 years (inclusive) at the time of enrollment of both genders
  • Signature of the informed consent
  • Availability of a mobile phone capable of installing VIR@PP

You may not qualify if:

  • Inability to adequately understand the Italian language
  • Presence of autoimmune pathologies, immunodeficiency, neuromuscular diseases, congenital cardiomyopathies, metabolic diseases
  • Presence of other syndromes and genetic pathologies
  • Patients on therapy with other drugs (steroids for topical and/or oral use)
  • Abnormalities of the nose or other conditions (e.g. severe hypotonia etc…) which make the administration of a nasal spray impossible or unsafe
  • Denial of informed consent
  • Participation in other clinical studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Campania Luigi Vanvitelli

Naples, 80138, Italy

RECRUITING

MeSH Terms

Conditions

Respiratory SoundsRespiratory Tract Infections

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsInfectionsRespiratory Tract Diseases

Study Officials

  • Michele Miraglia del Giudice, Prof.

    University of Campania Luigi Vanvitelli - Naples; Italy 80138

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Miraglia del Giudice, Prof

CONTACT

0815665470Michele.MIRAGLIADELGIUDICE@unina2.it

Michele Miraglia del Giudice, Prof.

CONTACT

0815665470Michele.MIRAGLIADELGIUDICE@unina2.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 13, 2023

Study Start

November 1, 2022

Primary Completion

December 31, 2023

Study Completion

May 31, 2024

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)