Trial Outcomes & Findings for Efficacy of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Children (5-<12 Years) With Acute Bronchial Obstruction (NCT NCT00460577)

Results Overview

Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Maximum Expiratory Flow.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

Baseline,4 hours

Results posted on

2011-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	Formoterol (Foradil®) Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.	Fenoterol 0.5 mg + Berodual® Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
Overall Study STARTED	30	30
Overall Study COMPLETED	28	24
Overall Study NOT COMPLETED	2	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Formoterol (Foradil®) Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.	Fenoterol 0.5 mg + Berodual® Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
Overall Study Protocol Violation	2	6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Formoterol (Foradil®) n=30 Participants Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.	Fenoterol 0.5 mg + Berodual® n=30 Participants Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	7.8 years STANDARD_DEVIATION 1.5 • n=5 Participants	7.8 years STANDARD_DEVIATION 2.1 • n=7 Participants	7.8 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Maximum Inspiratory Flow	77.7 Liters/minute STANDARD_DEVIATION 16.7 • n=5 Participants	79.9 Liters/minute STANDARD_DEVIATION 17.5 • n=7 Participants	78.8 Liters/minute STANDARD_DEVIATION 0 • n=5 Participants
Maximum Expiratory Flow	140.3 Liters/minute STANDARD_DEVIATION 33.1 • n=5 Participants	150.3 Liters/minute STANDARD_DEVIATION 36.6 • n=7 Participants	145.3 Liters/minute STANDARD_DEVIATION 0 • n=5 Participants
Forced Expiratory Flow 1 sec	1.06 Liters STANDARD_DEVIATION 0.280 • n=5 Participants	1.12 Liters STANDARD_DEVIATION 0.289 • n=7 Participants	1.09 Liters STANDARD_DEVIATION 0 • n=5 Participants
Forced Expiratory Flow 1 sec as a Percentage of Predicted	67.05 Percentage of Predicted STANDARD_DEVIATION 15.22 • n=5 Participants	71.17 Percentage of Predicted STANDARD_DEVIATION 15.76 • n=7 Participants	69.11 Percentage of Predicted STANDARD_DEVIATION 0 • n=5 Participants
Conway Clinical Scale	4.1 score on a scale STANDARD_DEVIATION 1.4 • n=5 Participants	4.0 score on a scale STANDARD_DEVIATION 1.5 • n=7 Participants	4.05 score on a scale STANDARD_DEVIATION 0 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline,4 hours

Population: 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.

Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Maximum Expiratory Flow.

Outcome measures

Outcome measures
Measure	Formoterol (Foradil®) n=28 Participants Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.	Fenoterol 0.5 mg + Berodual® n=24 Participants Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation	44 Liters/minute Standard Deviation 26.87	43.67 Liters/minute Standard Deviation 20.48

PRIMARY outcome

Timeframe: Baseline,4 hours

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Formoterol (Foradil®) n=28 Participants Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.	Fenoterol 0.5 mg + Berodual® n=24 Participants Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation	0.32 Liters Standard Deviation 0.2	0.34 Liters Standard Deviation 0.22

PRIMARY outcome

Timeframe: Baseline, 4 hours

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Formoterol (Foradil®) n=28 Participants Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.	Fenoterol 0.5 mg + Berodual® n=24 Participants Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
Mean Change in Pulse Oxymetry From Baseline to Final Evaluation	2.57 percentage Standard Deviation 1.67	2.83 percentage Standard Deviation 2.51

PRIMARY outcome

Timeframe: Baseline,4 hours

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Formoterol (Foradil®) n=28 Participants Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.	Fenoterol 0.5 mg + Berodual® n=24 Participants Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation	-3.18 score on a scale Standard Deviation 1.59	-3.04 score on a scale Standard Deviation 1.83

SECONDARY outcome

Timeframe: 4 hours

Not posted: see comment in Limitations and Caveats.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 hours

Population: 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.

Pharmacoeconomic analysis comparing the mean direct costs (total cost per prescription) of treatment with Formoterol (Foradil®) to treatment with Fenoterol 0.5 mg + Berodual®.

Outcome measures

Outcome measures
Measure	Formoterol (Foradil®) n=28 Participants Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.	Fenoterol 0.5 mg + Berodual® n=24 Participants Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
Pharmacoeconomic Analysis	9.21 Cost in US Dollars Interval 6.19 to 12.93	25.67 Cost in US Dollars Interval 21.95 to 29.91

Adverse Events

Formoterol (Foradil®)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fenoterol 0.5 mg + Berodual®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER