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Efficacy of Nebulised Beclometasone in Viral Wheezing Prophylaxis

NCT01265342 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2014-03-11

No results posted yet for this study

Summary

Inhaled steroids, in particular beclomethasone, are widely prescribed in Italy as symptomatic treatment of upper respiratory infections without evidence of efficacy.

The purpose of this study is to evaluate the efficacy of beclomethasone (administered by nebuliser twice a day) in preventing viral wheezing in pre-school children who had had episodes in the preceding 12 months.

Conditions

  • Bronchial Spasm
  • Respiratory Sounds
  • Respiratory Tract Infections

Interventions

DRUG

Beclomethasone

Beclomethasone nebulised suspension 400 micrograms twice a day for 10 days

DRUG

Placebo

Placebo nebulised suspension twice a day for 10 days

Sponsors & Collaborators

  • Agenzia Italiana del Farmaco

    collaborator OTHER_GOV

  • Associazione Culturale Pediatri

    collaborator UNKNOWN

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Principal Investigators

  • Antonio Clavenna, MD · Mario Negri Institute for Pharmacological Research, Milan, Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
71 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-03-31
Completion
2012-10-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT01265342 on ClinicalTrials.gov