A Phase 3 interventional study of beclomethasone dipropionate suspension for nebulisation 800 mcg/2 ml and Placebo solution for nebulisation 2 ml in Croup, sponsored by Chiesi Farmaceutici S.p.A.. Terminated at 1 site in Italy. Open to participants aged 6 Months to 3 Years. Per ClinicalTrials.gov, last updated 2011-04-29.
Sponsored by Chiesi Farmaceutici S.p.A. · Phase 3, Interventional, and Treatment
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.
18 studies on the registry are indexed under Croup; 2 are open to participants now.
This study's enrollment of 6 is below the median of 86 across 12 interventional studies indexed under Croup.
Browse Croup studies →Chiesi Farmaceutici S.p.A. is the lead sponsor of 185 studies on the registry; 22 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 11 (61%) have results posted.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: beclomethasone dipropionate suspension for nebulisation 800 mcg/2 ml
Drug: Placebo solution for nebulisation 2 ml
Single dose 1600 mcg/4 ml
single dose: 4 ml
To demonstrate superiority of nebulized BDP vs placebo in Westley croup score at 6 h
Time frame: 6 h
This study is terminated, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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