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

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

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Formoterol (Foradil®)
  • Formoterol (Foradil®) 12 micrograms administered through 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.

Primary Measures

• Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation
  • Time Frame: Baseline,4 hours
    Safety Issue?: Yes
• Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation
  • Time Frame: Baseline,4 hours
    Safety Issue?: Yes
• Mean Change in Pulse Oxymetry From Baseline to Final Evaluation
  • Time Frame: Baseline, 4 hours
    Safety Issue?: Yes
• Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation
  • Time Frame: Baseline,4 hours
    Safety Issue?: Yes

Secondary Measures

• Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events
  • Time Frame: 4 hours
    Safety Issue?: Yes
• Pharmacoeconomic Analysis
  • Time Frame: 4 hours
    Safety Issue?: No

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 Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis de Venezuela Study Chair Novartis de Venezuela  

Information obtained from ClinicalTrials.gov on February 12, 2012

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