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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00273962 |
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
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: ipratropium plus salbutamol UDV Drug: salbutamol UDV |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Combivent UDV vs. Salbutamol UDV (2.5mg) for Treatment of an Acute Exacerbation of Asthma in Children |
Estimated Enrollment: | 490 |
Study Start Date: | May 2002 |
Estimated Study Completion Date: | November 2003 |
A Comparison of Ipratropium 500mcg and salbutamol 2.5mg (Combivent UDV) and salbutamol UDV alone (2.5mg) 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.
Comparison(s):
Ipratropium bromide 500 mcg plus salbutamol 2.5mg (Combivent) vs salbutamol (2.5mg) alone given every 20 minutes for 3 doses
Ages Eligible for Study: | 2 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
EXCLUSION CRITERIA
Philippines | |
Philipines Heart Center | |
Quezon City, Philippines | |
San Juan de Dios Hospital | |
Pasay, Philippines | |
Philippine Children's Medical Center | |
Quezon, Philippines, 1104 | |
Philippine General Hospital | |
Manila, Philippines | |
Rizal Provincial Hospital | |
Pasig, Philippines | |
Quirino Memorial Medical Center | |
Quezon City, Philippines | |
Amang Rodriguez Hospital | |
Marikina, Philippines | |
Quezon City General Hospital | |
Quezon, Philippines | |
East Ave Medical Center | |
Quezon City, Philippines | |
Jose Reyes Memorial Medical Center | |
Manila, Philippines |
Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. (Phil) Inc. |
Study ID Numbers: | 1012.45 |
Study First Received: | January 9, 2006 |
Last Updated: | March 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00273962 History of Changes |
Health Authority: | Philippines: Bureau of Food and Drugs |
Neurotransmitter Agents Cholinergic Antagonists Adrenergic beta-Agonists Adrenergic Agents Bronchial Diseases Albuterol Asthma Anti-Asthmatic Agents Cholinergic Agents Adrenergic Agonists |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Ipratropium Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Respiratory System Agents Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Bronchial Diseases Adrenergic Agents Albuterol Physiological Effects of Drugs Reproductive Control Agents Cholinergic Agents Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases |
Tocolytic Agents Therapeutic Uses Immune System Diseases Adrenergic beta-Agonists Asthma Anti-Asthmatic Agents Pharmacologic Actions Ipratropium Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |