drugset / Trial / NCT00497523

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 ↗

Phase 3 Completed 283 enrolled Chiesi Farmaceutici S.p.A.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2006-03
Primary completion
—
Completion
2007-01

Outcome

Met primary endpoint

paper the percentage of symptom-free days was higher with regular beclomethasone (69.6%, SD 20.89; P = 0.034) PMID 19772514 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Salbutamol Unknown 1600 ug Inhaled
Comparator Salbutamol Unknown 2500 ug Inhaled
Subject beclomethasone dipropionate Other / unclassified 400 ug Inhaled
Subject beclomethasone dipropionate Other / unclassified 800 ug Inhaled

Indications