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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
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 ]

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

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

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

5.  Secondary:   Pharmacoeconomic Analysis   [ Time Frame: 4 hours ]

6.  Secondary:   Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events   [ Time Frame: 4 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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:
unchecked 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.
unchecked 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.


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