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Efficacy and Safety of Nebulised Beclomethasone Dipropionate Plus as Needed Salbutamol vs as Needed Salbutamol or as Needed Salbutamol/Beclomethasone Fixed Combination in Young Children With Asthma Symptoms

NCT00497523 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 283

Last updated 2020-08-03

No results posted yet for this study

Summary

To demonstrate a superior efficacy of BDP plus rescue salbutamol suspension for nebulisation, compared to placebo plus rescue salbutamol, in the relief of symptoms of asthma in young children with persistent symptoms of asthma.

Conditions

  • Bronchial Asthma

Interventions

DRUG

Beclomethasone dipropionate

DRUG

Beclomethasone dipropionate/Salbutamol combination

DRUG

Salbutamol

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Renato Cutrera, MD · Department of Pediatric Medicine, Children's Hospital and Research Institute Bambino Gesù, Rome, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Completion
2007-01-31

Countries

  • Poland
  • Ukraine

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 NCT00497523 on ClinicalTrials.gov