Efficacy of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Children (5-<12 Years) With Acute Bronchial Obstruction

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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 obstruction attending emergency services

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Bromides; Fenoterol; Fenoterol, ipratropium drug combination; Formoterol Fumarate; Ipratropium

Criteria

Inclusion Criteria:

• Asthmatic children 5-<12 years old, requiring emergency services for acute bronchial obstruction mild to moderate determined by functional and clinical evidence

Exclusion Criteria:

• 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