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

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00460577

First received: April 13, 2007

Last updated: March 23, 2011

Last verified: March 2011

History of Changes

Results First Received: December 13, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Acute Bronchial Obstruction, Asthma
Interventions:	Drug: Formoterol fumerate Drug: fenoterol/ipratropium bromide

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Formoterol (Foradil®)	Fenoterol 0.5 mg + Berodual®
STARTED	30 ^[1]	30
COMPLETED	28	24
NOT COMPLETED	2	6
Protocol Violation	2	6

[1]	148 patients were screened; however, 22 did not consent and 66 did not meet inclusion/exclusion.

Baseline Characteristics

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Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Formoterol (Foradil®)	Fenoterol 0.5 mg + Berodual®	Total
Number of Participants [units: participants]	30	30	60
Age [units: participants]
<=18 years	30	30	60
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	7.8 ± 1.5	7.8 ± 2.1	7.8 ± 0
Gender [units: participants]
Female	12	11	23
Male	18	19	37
Maximum Inspiratory Flow ^[1] [units: Liters/minute] Mean ± Standard Deviation	77.7 ± 16.7	79.9 ± 17.5	78.8 ± 0
Maximum Expiratory Flow ^[2] [units: Liters/minute] Mean ± Standard Deviation	140.3 ± 33.1	150.3 ± 36.6	145.3 ± 0
Forced Expiratory Flow 1 sec ^[3] [units: Liters] Mean ± Standard Deviation	1.06 ± 0.280	1.12 ± 0.289	1.09 ± 0
Forced Expiratory Flow 1 sec as a Percentage of Predicted ^[4] [units: Percentage of Predicted] Mean ± Standard Deviation	67.05 ± 15.22	71.17 ± 15.76	69.11 ± 0
Conway Clinical Scale ^[5] [units: score on a scale] Mean ± Standard Deviation	4.1 ± 1.4	4.0 ± 1.5	4.05 ± 0

[1]	Mean of the Maximum Inspiratory Flow
[2]	Mean of Maximum Expiratory Flow
[3]	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.
[4]	Mean Expiratory Flow 1 second as a Percentage of Predicted
[5]	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.

Outcome Measures

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1. Primary:

Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation [ Time Frame: Baseline,4 hours ]

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2. Primary:

Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation [ Time Frame: Baseline,4 hours ]

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3. Primary:

Mean Change in Pulse Oxymetry From Baseline to Final Evaluation [ Time Frame: Baseline, 4 hours ]

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4. Primary:

Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation [ Time Frame: Baseline,4 hours ]

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5. Secondary:

Pharmacoeconomic Analysis [ Time Frame: 4 hours ]

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6. Secondary:

Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events [ Time Frame: 4 hours ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	External affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00460577 History of Changes
Other Study ID Numbers:	CFOR258DVE02
Study First Received:	April 13, 2007
Results First Received:	December 13, 2010
Last Updated:	March 23, 2011
Health Authority:	Venezuela: Instituto Nacional de Higiene

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