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

Study Overview
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Brief Summary
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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

Official Title
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Randomized, Double Blind, Double Dummy, Placebo Controlled Trial to Compare the Effectiveness of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Asthmatic Children (5-<12 Years) With Acute Bronchial Obstruction Attending Emergency Services

Conditions
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Acute Bronchial Obstruction, Asthma

Intervention / Treatment
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* Drug: Formoterol fumerate
* Drug: fenoterol/ipratropium bromide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Formoterol (Foradil®)<br>Formoterol (Foradil®) 12 micrograms administered through Aerolizer®. | Drug: Formoterol fumerate<br>* 12 micrograms stat (twice if necessary). Inhaled via aerolizer<br>|
| Active Comparator: Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg<br>Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized. | Drug: fenoterol/ipratropium bromide<br>* 0.5 micrograms/0.25 milligrams (20 drops) inhaled via nebulization diluted in 3cc of 0.9% saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation | Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Maximum Expiratory Flow. | Baseline,4 hours | 
| Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation | 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. | Baseline,4 hours | 
| Mean Change in Pulse Oxymetry From Baseline to Final Evaluation | 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. | Baseline, 4 hours | 
| Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation | 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. | Baseline,4 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Formoterol, Bronchial Obstruction, Children