MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, TWO-ARM PARALLEL GROUPS STUDY DESIGN TO DEMONSTRATE THE EFFICACY AND TOLERABILITY OF A SINGLE DOSE OF BDP SUSPENSION FOR NEBULISATION 1600 mcg VS PLACEBO IN THE TREATMENT OF CHILDREN AGED 6 MONTHS TO 3 YEARS WITH A CLINICAL DIAGNOSIS OF MODERATE CROUP - ND
- Conditions
- CROUP (acute laryngotracheobronchitis)MedDRA version: 12.1Level: LLTClassification code 10011416Term: Croup infectious
- Registration Number
- EUCTR2009-014376-22-IT
- Lead Sponsor
- CHIESI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1)Written informed consent obtained by parents/legal representative prior to any study-related procedures; 2)Male or Female subject aged between 6 months and 3 years referring to ER with acute onset barky cough, stridor, hoarseness, and respiratory distress; 3)Children with a diagnosis of moderate croup (Westley score 3-8).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1)Symptoms or signs of any other cause of stridor; 2) Previous acute angioneurotic oedema; 3) Children with diagnosis of severe croup (Westley score > 8) 4) 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; 5)Any other severe acute or chronic medical or psychiatriccondition 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 judgement of the investigator, would make the subject inappropriate for entry into this study; 6) Treatment with oral or parenteral corticosteroids within the previous 2 weeks; 7) Treatment with epinephrine for respiratory distress before enrollment; 8) Previous visit to an emergency room department due to croup during this episode of the disease; 9) Inability of the parent to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments; 10) Enrollment in another clinical trial in the previous 4 weeks or subject already admitted in this study; 11) Lack of a telephone at home.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method