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

Novartis60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Acute Bronchial Obstruction, Asthma

Interventions

Formoterol fumerateDRUG

12 micrograms stat (twice if necessary). Inhaled via aerolizer

fenoterol/ipratropium bromideDRUG

0.5 micrograms/0.25 milligrams (20 drops) inhaled via nebulization diluted in 3cc of 0.9% saline.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (2)

Novartis Investigator site - five sites in Caracas

Caracas, Venezuela

Novartis Investigator Site

Maracaibo, Venezuela

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline,4 hours

Secondary Outcomes

Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events

Not posted: see comment in Limitations and Caveats.

Time frame: 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®.

Data from ClinicalTrials.gov

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