Status:
COMPLETED
A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Asthma
Eligibility:
All Genders
2-10 years
Phase:
PHASE4
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 Exacerbati...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- All patients must have a known history of asthma and present to the hospital/clinic with severe acute exacerbation.
- Male or female patients 2 to 10 years of age.
- Parents or legal guardians of patients must sign an Informed Consent Form prior to participation in the trial.
- EXCLUSION CRITERIA
- Patients with known or suspected hypersensitivity to study drugs
- Patients with medical condition that would contraindicate the use of beta2-adrenergic or anticholinergic medications
- Patients with first wheezing episode only
- Prior intubation for asthma for more than 24 hours
- Patients who used ipratropium within six hours prior to consultation
- Patients with concurrent stridor or possible presence of intra-thoracic foreign body
- Patients with disease known to have chronic effect on respiratory function ( e.g., cystic fibrosis or cardiac disease)
- Patients requiring immediate resuscitation or airway intervention
- With psychiatric disease or psychosocial problems
- Patients on other investigational drugs or have used any other investigational drugs within the past month
Exclusion
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2003
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00273962
Start Date
May 1 2002
End Date
November 1 2003
Last Update
October 29 2013
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Jose Reyes Memorial Medical Center
Manila, Philippines
2
Philippine General Hospital
Manila, Philippines
3
Amang Rodriguez Hospital
Marikina City, Philippines
4
San Juan de Dios Hospital
Pasay, Philippines