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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-09-30

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

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Detailed Description

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Conditions

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Acute Bronchial Obstruction, Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Formoterol (Foradil®)

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

Group Type ACTIVE_COMPARATOR

Formoterol fumerate

Intervention Type DRUG

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

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

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

Group Type ACTIVE_COMPARATOR

fenoterol/ipratropium bromide

Intervention Type DRUG

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

Interventions

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Formoterol fumerate

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

Intervention Type DRUG

fenoterol/ipratropium bromide

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

Intervention Type DRUG

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

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No