NCT00938353

Efficacy of Nebulized Beclomethasone Dipropionate (BDP) in the Treatment of Moderate Croup

Multicentre, Randomized, Double-blind, Placebo-controlled, Two-arm Parallel Groups Study Design to Demonstrate the Efficacy and Tolerability of a Single Dose of BDP Suspension for Nebulisation 1600 µg vs Placebo in the Treatment of Children Aged 6 Months to 3 Years With a Clinical Diagnosis of Moderate Croup

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 6 Months – 3 Years
• Healthy volunteers: Not accepted

Summary

Acute laryngotracheobronchitis, better known as croup, is one of the common respiratory complaints among children and the most common cause of airway obstruction in children aged six months to six years. Patients with croup are typically visited by physicians during two peak time periods throughout the year. The first one is in the autumn, usually as a result of parainfluenza virus, and the second peak occurs in early winter, a consequence of RSV. Croup affects males more commonly than females and affects children between the ages of 6 months to 6 years. The incidence of croup peaks in children at 2 years of age; croup in older children is uncommon, and recurrent episodes are frequently observed. Croup symptoms are generally short-lived, with about 60% of children showing resolution of their barky cough within 48 h. However, a few children continue to have symptoms for up to 1 week. Although most children with croup recover without specific treatment, up to 15% require hospital admission, and, among those admitted, up to 5% may require intubation. Nebulised adrenaline is effective but it has a short duration of action and potentially dangerous side effects, and it is therefore not recommended for use in the community in mild-moderate Croup. Oral and intramuscular steroid treatment, when given in adequate doses in hospital, has been shown to be effective for moderate to severe croup in a number of trials and a meta analysis. It has been suggested that nebulised administration is superior to the oral or intramuscular route of administration for a more rapid onset of action and fewer side-effects. This study is aimed to demonstrate the effectiveness of nebulised steroid administration as beclomethasone dipropionate in croup patients compare to placebo.

Conditions

• Croup

Interventions

Type	Name	Description
DRUG	beclomethasone dipropionate suspension for nebulisation 800 mcg/2 ml	Single dose 1600 mcg/4 ml
DRUG	Placebo solution for nebulisation 2 ml	single dose: 4 ml

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-07-13
• Last updated: 2011-04-29

Locations

1 site across 1 country: Italy