Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Formoterol fumerate
  • 12 micrograms stat (twice if necessary). Inhaled via aerolizer
• Drug: fenoterol/ipratropium bromide
  • 0.5 micrograms/0.25milligrams (20 drops) inhaled via nebulization diluted in 3cc of 0.9% saline.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2

Primary Measures

• Efficacy assessed by: Maximum Expiratory Flow, Forced Expiratory Volume in 1 second, Pulse Oxymetry and Conway Clinical Scale

Secondary Measures

• Safety assessed by: Pulse Oxymetry, Clinical Assessments, Adverse events
• Pharmacoeconomic Analysis

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 5 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis de Venezuela Study Chair Novartis de Venezuela  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00460577

Study ID Number: CFOR258DVE02

ClinicalTrials.gov Identifier: NCT00460577

Health Authority: Venezuela: Instituto Nacional de Higiene