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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00460577

Enrollment

Registered

2007-04-16

Start date

2007-03-31

Completion date

2008-09-30

Last updated

2011-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bronchial Obstruction, Asthma

Keywords

Asthma, Formoterol, Bronchial Obstruction, Children

Brief 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

Interventions

DRUGFormoterol fumerate

12 micrograms stat (twice if necessary). Inhaled via aerolizer

DRUGfenoterol/ipratropium bromide

0.5 micrograms/0.25 milligrams (20 drops) inhaled via nebulization diluted in 3cc of 0.9% saline.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 12 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame	Description
Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation	Baseline,4 hours	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	Baseline,4 hours	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	Baseline, 4 hours	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	Baseline,4 hours	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

Measure	Time frame	Description
Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events	4 hours	Not posted: see comment in Limitations and Caveats.
Pharmacoeconomic Analysis	4 hours	Pharmacoeconomic analysis comparing the mean direct costs (total cost per prescription) of treatment with Formoterol (Foradil®) to treatment with Fenoterol 0.5 mg + Berodual®.

Countries

Venezuela

Participant flow

Participants by arm

Arm	Count
Formoterol (Foradil®) Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.	30
Fenoterol 0.5 mg + Berodual® Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.	30
Total	60

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Protocol Violation	2	6

Baseline characteristics

Characteristic	Formoterol (Foradil®)	Fenoterol 0.5 mg + Berodual®	Total
Age, Categorical <=18 years	30 Participants	30 Participants	60 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age Continuous	7.8 years STANDARD_DEVIATION 1.5	7.8 years STANDARD_DEVIATION 2.1	7.8 years STANDARD_DEVIATION 0
Conway Clinical Scale	4.1 score on a scale STANDARD_DEVIATION 1.4	4.0 score on a scale STANDARD_DEVIATION 1.5	4.05 score on a scale STANDARD_DEVIATION 0
Forced Expiratory Flow 1 sec	1.06 Liters STANDARD_DEVIATION 0.28	1.12 Liters STANDARD_DEVIATION 0.289	1.09 Liters STANDARD_DEVIATION 0
Forced Expiratory Flow 1 sec as a Percentage of Predicted	67.05 Percentage of Predicted STANDARD_DEVIATION 15.22	71.17 Percentage of Predicted STANDARD_DEVIATION 15.76	69.11 Percentage of Predicted STANDARD_DEVIATION 0
Maximum Expiratory Flow	140.3 Liters/minute STANDARD_DEVIATION 33.1	150.3 Liters/minute STANDARD_DEVIATION 36.6	145.3 Liters/minute STANDARD_DEVIATION 0
Maximum Inspiratory Flow	77.7 Liters/minute STANDARD_DEVIATION 16.7	79.9 Liters/minute STANDARD_DEVIATION 17.5	78.8 Liters/minute STANDARD_DEVIATION 0
Sex: Female, Male Female	12 Participants	11 Participants	23 Participants
Sex: Female, Male Male	18 Participants	19 Participants	37 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 30	0 / 30
serious Total, serious adverse events	0 / 30	0 / 30

Outcome results

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.

Time frame: Baseline,4 hours