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

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

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 Overview

• Status: Completed
• Conditions: Acute Bronchial Obstruction, Asthma
• Intervention / Treatment: Drug: Formoterol fumerate; Drug: fenoterol/ipratropium bromide

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Venezuela
  • Caracas, Venezuela
    • Novartis Investigator site - five sites in Caracas
  • Maracaibo, Venezuela
    • Novartis Investigator Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Formoterol (Foradil®); Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.	Drug: Formoterol fumerate; 12 micrograms stat (twice if necessary). Inhaled via aerolizer
ACTIVE_COMPARATOR: 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.	Drug: fenoterol/ipratropium bromide; 0.5 micrograms/0.25 milligrams (20 drops) inhaled via nebulization diluted in 3cc of 0.9% saline.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis
• Investigators: Study Chair: Novartis de Venezuela, Novartis de Venezuela

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (ACTUAL): September 1, 2008
• Study Completion (ACTUAL): September 1, 2008

Study Registration Dates

• First Submitted: April 13, 2007
• First Submitted That Met QC Criteria: April 13, 2007
• First Posted (ESTIMATE): April 16, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): April 19, 2011
• Last Update Submitted That Met QC Criteria: March 23, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Asthma, Formoterol, Bronchial Obstruction, Children
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Adrenergic Agonists; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Sympathomimetics; Bromides; Ipratropium; Formoterol Fumarate; Fenoterol
• Other Study ID Numbers: CFOR258DVE02