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

Phase 4

Completed

Interventions: Drug: Formoterol fumerate
Drug: fenoterol/ipratropium bromide

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 obstruction attending emergency services

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Formoterol (Foradil®)	Formoterol fumerate	Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg	fenoterol/ipratropium bromide	Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.

Primary Outcome Measures

Name	Time	Method
Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation	Baseline,4 hours	Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Maximum Expiratory Flow.
Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation	Baseline,4 hours	Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Forced Expiratory Volume in 1 second. FEV1 is defined as the volume of air that can be forced out of the lungs in 1 second after taking a deep breath.
Mean Change in Pulse Oxymetry From Baseline to Final Evaluation	Baseline, 4 hours	Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Pulse Oximetry used to monitor the percentage of oxygen saturation of hemoglobin in the blood.
Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation	Baseline,4 hours	Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by the Conway Clinical Scale. Assessment of the following: Wheezing, Accessory Muscle Use and Pulse Frequency in a 0 to 3 point scale according to severity for a minimum of 0 points and a total of 9 points in a very severe clinical case.

Secondary Outcome Measures

Name	Time	Method
Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events	4 hours	Not posted: see comment in Limitations and Caveats.
Pharmacoeconomic Analysis	4 hours	Pharmacoeconomic analysis comparing the mean direct costs (total cost per prescription) of treatment with Formoterol (Foradil®) to treatment with Fenoterol 0.5 mg + Berodual®.