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Evaluate the Effect of Nasal Spray in the Prevention of RTI in Children With Pre-school Wheezing

NCT05684848 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2023-01-17

No results posted yet for this study

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.

Conditions

  • Wheezing
  • Recurrent Respiratory Tract Infections

Interventions

DEVICE

Resveratrol + CMG

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.

DEVICE

Isotonic solution

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.

Sponsors & Collaborators

  • Noos S.r.l.

    lead INDUSTRY

Principal Investigators

  • Michele Miraglia del Giudice, Prof. · University of Campania Luigi Vanvitelli - Naples; Italy 80138

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-12-31
Completion
2024-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05684848 on ClinicalTrials.gov