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

Novartis

Status and phase: Completed; Phase 4

Conditions: Acute Bronchial Obstruction, Asthma

Treatments: Drug: Formoterol fumerate; Drug: fenoterol/ipratropium bromide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00460577

CFOR258DVE02

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Formoterol (Foradil®)

Active Comparator group

Description:

Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.

Treatment:

Drug: Formoterol fumerate

Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg

Active Comparator group

Description:

Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.

Treatment:

Drug: fenoterol/ipratropium bromide