A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg)

Phase 4

Completed

• Conditions: Asthma

• Registration Number: NCT00273962
• Lead Sponsor: Boehringer Ingelheim

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 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 Timeline

• Study Start: 2002-05
• Primary Completion: 2003-11
• Study Completion: 2003-11
• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-09
• Study First Posted: 2006-01-10
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The proportion of patients showing improvement in asthma severity scores from severe at baseline to mild at the end of the treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

Philippine General Hospital; 🇵🇭 Manila, Philippines

Amang Rodriguez Hospital; 🇵🇭 Marikina, Philippines

Quirino Memorial Medical Center; 🇵🇭 Quezon City, Philippines

Philippine Children's Medical Center; 🇵🇭 Quezon, Philippines

East Ave Medical Center; 🇵🇭 Quezon City, Philippines

Jose Reyes Memorial Medical Center; 🇵🇭 Manila, Philippines

Quezon City General Hospital; 🇵🇭 Quezon, Philippines

Rizal Provincial Hospital; 🇵🇭 Pasig, Philippines

San Juan de Dios Hospital; 🇵🇭 Pasay, Philippines

Philipines Heart Center; 🇵🇭 Quezon City, Philippines