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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formoterol (Foradil®) | Active Comparator | Formoterol (Foradil®) 12 micrograms administered through Aerolizer®. |
|
| Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg | Active Comparator | Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formoterol fumerate | Drug | 12 micrograms stat (twice if necessary). Inhaled via aerolizer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events | Not posted: see comment in Limitations and Caveats. | 4 hours |
| 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®. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis de Venezuela | Novartis de Venezuela | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator site - five sites in Caracas | Caracas | Venezuela | ||||
| Novartis Investigator Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Formoterol (Foradil®) | Formoterol (Foradil®) 12 micrograms administered through Aerolizer®. |
| FG001 | Fenoterol 0.5 mg + Berodual® | Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Formoterol (Foradil®) | Formoterol (Foradil®) 12 micrograms administered through Aerolizer®. |
| BG001 | Fenoterol 0.5 mg + Berodual® | Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug. | Posted | Mean | Standard Deviation | Liters/minute | Baseline,4 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Formoterol (Foradil®) | Formoterol (Foradil®) 12 micrograms administered through Aerolizer®. |
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Secondary Outcome Measure 2: Safety Assessed by Pulse Oxymetry, Clinical Assessments, Adverse Events has not been posted. Analysis of Pulse Oxymetry and Clinical Assessment was not performed. Adverse events are reported in the Adverse Event section.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D005280 | Fenoterol |
| D009241 | Ipratropium |
| ID | Term |
|---|---|
| D009921 | Metaproterenol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| fenoterol/ipratropium bromide | Drug | 0.5 micrograms/0.25 milligrams (20 drops) inhaled via nebulization diluted in 3cc of 0.9% saline. |
|
| 4 hours |
| Maracaibo |
| Venezuela |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Maximum Inspiratory Flow | Mean of the Maximum Inspiratory Flow | Mean | Standard Deviation | Liters/minute |
|
| Maximum Expiratory Flow | Mean of Maximum Expiratory Flow | Mean | Standard Deviation | Liters/minute |
|
| Forced Expiratory Flow 1 sec | Mean of Forced Expiratory Flow one second (FEV1) defined as the volume of air that can be forced out in 1 second after taking a deep breath. | Mean | Standard Deviation | Liters |
|
| Forced Expiratory Flow 1 sec as a Percentage of Predicted | Mean Expiratory Flow 1 second as a Percentage of Predicted | Mean | Standard Deviation | Percentage of Predicted |
|
| Conway Clinical Scale | Mean of Clinical Scale score measured by 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. | Mean | Standard Deviation | score on a scale |
|
|
|
| Secondary | Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events | Not posted: see comment in Limitations and Caveats. | Not Posted | Number | Participants | 4 hours |
| 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®. | Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug. | Posted | Mean | Full Range | Cost in US Dollars | 4 hours |
|
|
|
| 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. | Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug. | Posted | Mean | Standard Deviation | Liters | Baseline,4 hours |
|
|
|
| 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. | Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug. | Posted | Mean | Standard Deviation | percentage | Baseline, 4 hours |
|
|
|
| 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. | Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug. | Posted | Mean | Standard Deviation | score on a scale | Baseline,4 hours |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Fenoterol 0.5 mg + Berodual® | Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized. | 0 | 30 | 0 | 30 |
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D000588 | Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |