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
  Purpose

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


Condition Intervention Phase
Acute Bronchial Obstruction, Asthma
Drug: Formoterol fumerate
Drug: fenoterol/ipratropium bromide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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®.


Enrollment: 60
Study Start Date: March 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460577

Locations
Venezuela
Novartis Investigator site - five sites in Caracas
Caracas, Venezuela
Novartis Investigator Site
Maracaibo, Venezuela
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis de Venezuela Novartis de Venezuela
  More Information

No publications provided

Responsible Party: External affairs, Novartis
ClinicalTrials.gov Identifier: NCT00460577     History of Changes
Other Study ID Numbers: CFOR258DVE02
Study First Received: April 13, 2007
Results First Received: December 13, 2010
Last Updated: March 23, 2011
Health Authority: Venezuela: Instituto Nacional de Higiene

Keywords provided by Novartis:
Asthma, Formoterol, Bronchial Obstruction, Children

Additional relevant MeSH terms:
Formoterol
Fenoterol, ipratropium drug combination
Fenoterol
Ipratropium
Bromides
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Central Nervous System Agents
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on September 22, 2014