Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273962
Status:
COMPLETED
Last Update Posted:
2013-10-29
First Post:
2006-01-09
Brief Title:
A Comparison of Combivent UDV Ipratropium 500mcg and Salbutamol 25mg and Salbutamol UDV Alone 25mg
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Comparison of Combivent UDV Ipratropium 500mcg and Salbutamol 25mg and Salbutamol UDV Alone 25mg in a Double-Blind Efficacy and Safety Study in Asthmatic Children With Severe Acute Exacerbation
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the bronchodilator efficacy of ipratropium plus salbutamol Combivent with salbutamol alone given every 20 minutes for three doses in asthmatic children with severe acute exacerbation
Detailed Description:
A Comparison of Ipratropium 500mcg and salbutamol 25mg Combivent UDV and salbutamol UDV alone 25mg in a Double-blind Efficacy and Safety Study in Asthmatic Children with Severe Acute Exacerbation
Study Hypothesis
Several studies including a study conducted in an emergency room setting demonstrated that the addition of ipratropium bromide an anticholinergic drug to standard salbutamol therapy significantly improves pulmonary function as compared to salbutamol alone
Comparisons
Ipratropium bromide 500 mcg plus salbutamol 25mg Combivent vs salbutamol 25mg alone given every 20 minutes for 3 doses
Study Hypothesis
Several studies including a study conducted in an emergency room setting demonstrated that the addition of ipratropium bromide an anticholinergic drug to standard salbutamol therapy significantly improves pulmonary function as compared to salbutamol alone
Comparisons
Ipratropium bromide 500 mcg plus salbutamol 25mg Combivent vs salbutamol 25mg alone given every 20 minutes for 3 doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None