Efficacy of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Children (5-<12 Years) With Acute Bronchial Obstruction
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Bronchial Obstruction, Asthma
Intervention: Formoterol fumerate (Drug); fenoterol/ipratropium bromide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis de Venezuela, Study Chair, Affiliation: Novartis de Venezuela
Summary
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
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean Change in Maximum Expiratory Flow From Baseline to Final EvaluationMean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation Mean Change in Pulse Oxymetry From Baseline to Final Evaluation Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation
Secondary outcome: Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse EventsPharmacoeconomic Analysis
Eligibility
Minimum age: 5 Years.
Maximum age: 12 Years.
Gender(s): Both.
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
Locations and Contacts
Novartis Investigator site - five sites in Caracas, Caracas, Venezuela
Novartis Investigator Site, Maracaibo, Venezuela
Additional Information
Starting date: March 2007
Last updated: March 23, 2011
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