Acute Bronchial Obstruction, Asthma Clinical Trial
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
| Verified date | March 2011 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Venezuela: Instituto Nacional de Higiene |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | September 2008 |
| Est. primary completion date | September 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 5 Years to 12 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Venezuela | Novartis Investigator site - five sites in Caracas | Caracas | |
| Venezuela | Novartis Investigator Site | Maracaibo |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
Venezuela,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation | Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Maximum Expiratory Flow. | Baseline,4 hours | Yes |
| Primary | Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation | 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. | Baseline,4 hours | Yes |
| Primary | Mean Change in Pulse Oxymetry From Baseline to Final Evaluation | 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. | Baseline, 4 hours | Yes |
| Primary | Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation | 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. | Baseline,4 hours | Yes |
| Secondary | Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events | Not posted: see comment in Limitations and Caveats. | 4 hours | Yes |
| Secondary | Pharmacoeconomic Analysis | Pharmacoeconomic analysis comparing the mean direct costs (total cost per prescription) of treatment with Formoterol (Foradil®) to treatment with Fenoterol 0.5 mg + Berodual®. | 4 hours | No |