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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
500
Jose Reyes Memorial Medical Center
Manila, Philippines
Philippine General Hospital
Manila, Philippines
Amang Rodriguez Hospital
Marikina City, Philippines
San Juan de Dios Hospital
Pasay, Philippines
The proportion of patients showing improvement in asthma severity scores from severe at baseline to mild at the end of the treatment
Change in asthma severity scores from baseline to end of treatment; number of patients needing hospitalization; number of rescue medications; oxygen saturation, number of discharged patients revisiting the ER/doctors clinic
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