Status:
TERMINATED
Efficacy of Nebulized Beclomethasone Dipropionate (BDP) in the Treatment of Moderate Croup
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Croup
Eligibility:
All Genders
6-3 years
Phase:
PHASE3
Brief 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 yea...
Eligibility Criteria
Inclusion
- Written informed consent obtained by parents/legal representative prior to any study-related procedures.
- Male or female subject aged between 6 months and 3 years referring to ER with acute onset barky cough, stridor, hoarseness, and respiratory distress
- Children with a diagnosis of moderate croup (Westley score 3-8)
Exclusion
- Symptoms or signs of any other cause of stridor;
- Previous acute angioneurotic oedema;
- Children with diagnosis of severe croup (Wesley score \>8);
- History of congenital or acquired stridor, diagnosis of epiglottitis, chronic pulmonary disease, asthma, severe systemic disease, exposure to chickenpox virus within the previous 21 days, or known immune dysfunction;
- Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study;
- Treatment with oral or parenteral corticosteroids within the previous 2 weeks; Treatment with epinephrine for respiratory distress before enrollment;
- Previous visit to an emergency room department due to croup during this episode of the disease;
- Inability of the parent to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments;
- Enrollment in another clinical trial in the previous 4 weeks or subject already admitted in this study
- Lack of a telephone at home;
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00938353
Start Date
April 1 2010
End Date
September 1 2010
Last Update
April 29 2011
Active Locations (1)
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1
Ospedale San Giuseppe Moscati
Avellino, Italy, 83100