Croup Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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