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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00460577
First received: April 13, 2007
Last updated: March 23, 2011
Last verified: March 2011

April 13, 2007
March 23, 2011
March 2007
September 2008   (final data collection date for primary outcome measure)
  • Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation [ Time Frame: Baseline,4 hours ] [ Designated as safety issue: Yes ]
    Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Maximum Expiratory Flow.
  • Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation [ Time Frame: Baseline,4 hours ] [ Designated as safety issue: Yes ]
    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.
  • Mean Change in Pulse Oxymetry From Baseline to Final Evaluation [ Time Frame: Baseline, 4 hours ] [ Designated as safety issue: Yes ]
    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.
  • Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation [ Time Frame: Baseline,4 hours ] [ Designated as safety issue: Yes ]
    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.
  • Efficacy assessed by: Maximum Expiratory Flow, Forced Expiratory Volume in 1 second, Pulse Oxymetry and Conway Clinical Scale measured at 20, 60, 120 and 240 minutes after treatment
  • Efficacy:
  • Conway Clinical Scale. All measured at 20, 60, 120 and 240 minutes after treatment
Complete list of historical versions of study NCT00460577 on ClinicalTrials.gov Archive Site
  • Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
    Not posted: see comment in Limitations and Caveats.
  • Pharmacoeconomic Analysis [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    Pharmacoeconomic analysis comparing the mean direct costs (total cost per prescription) of treatment with Formoterol (Foradil®) to treatment with Fenoterol 0.5 mg + Berodual®.
  • Safety assessed by: Pulse Oxymetry, Clinical Assessments at 20, 60, 120 and 240 minutes after treatment, and adverse events within the 240 minute observation
  • Pharmacoeconomic Analysis
Not Provided
Not Provided
 
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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Bronchial Obstruction, Asthma
  • 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.
  • Active Comparator: Formoterol (Foradil®)
    Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
    Intervention: Drug: Formoterol fumerate
  • 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.
    Intervention: Drug: fenoterol/ipratropium bromide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2008
September 2008   (final data collection date for primary outcome measure)

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

Both
5 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Venezuela
 
NCT00460577
CFOR258DVE02
Not Provided
External affairs, Novartis
Novartis
Not Provided
Study Chair: Novartis de Venezuela Novartis de Venezuela
Novartis
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP