Status:
COMPLETED
Efficacy of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Children (5-<12 Years) With Acute Bronchial Obstruction
Lead Sponsor:
Novartis
Conditions:
Acute Bronchial Obstruction, Asthma
Eligibility:
All Genders
5-12 years
Phase:
PHASE4
Brief Summary
To determine efficacy and tolerability of inhaled Formoterol vs nebulized Ipatropioum Bromide plus Fenoterol in cumulative sequential doses in asthmatic children (5-\<12 years) with acute bronchial ob...
Eligibility Criteria
Inclusion
- Asthmatic children 5-\<12 years old, requiring emergency services for acute bronchial obstruction mild to moderate determined by functional and clinical evidence
Exclusion
- Patients with severe acute bronchial obstruction determined by functional and clinical evidence
- Patients unable to use the inhaling device at time of treatment
- Patients who received a bronchodilator drug within the last 12 hours
- Patients who received inhaled steroids within the last 72 hours
- Patients who received systemic steroids within the last 7 days
- Patients with near fatal asthma history
- Patients with fever (\>38.5°C axillar temp)
- Patients with any clinical significance condition
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00460577
Start Date
March 1 2007
End Date
September 1 2008
Last Update
April 19 2011
Active Locations (2)
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1
Novartis Investigator site - five sites in Caracas
Caracas, Venezuela
2
Novartis Investigator Site
Maracaibo, Venezuela