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Trial record 67 of 150 for:    Ipratropium OR atrovent

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

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ClinicalTrials.gov Identifier: NCT00460577
Recruitment Status : Completed
First Posted : April 16, 2007
Results First Posted : April 19, 2011
Last Update Posted : April 19, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Bronchial Obstruction, Asthma
Interventions Drug: Formoterol fumerate
Drug: fenoterol/ipratropium bromide
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual®
Hide Arm/Group Description Formoterol (Foradil®) 12 micrograms administered through Aerolizer®. Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
Period Title: Overall Study
Started 30 [1] 30
Completed 28 24
Not Completed 2 6
Reason Not Completed
Protocol Violation             2             6
[1]
148 patients were screened; however, 22 did not consent and 66 did not meet inclusion/exclusion.
Arm/Group Title Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual® Total
Hide Arm/Group Description Formoterol (Foradil®) 12 micrograms administered through Aerolizer®. Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized. Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
30
 100.0%
30
 100.0%
60
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
7.8  (1.5) 7.8  (2.1) 7.8  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
12
  40.0%
11
  36.7%
23
  38.3%
Male
18
  60.0%
19
  63.3%
37
  61.7%
Maximum Inspiratory Flow   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters/minute
Number Analyzed 30 participants 30 participants 60 participants
77.7  (16.7) 79.9  (17.5) 78.8  (0)
[1]
Measure Description: Mean of the Maximum Inspiratory Flow
Maximum Expiratory Flow   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters/minute
Number Analyzed 30 participants 30 participants 60 participants
140.3  (33.1) 150.3  (36.6) 145.3  (0)
[1]
Measure Description: Mean of Maximum Expiratory Flow
Forced Expiratory Flow 1 sec   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 30 participants 30 participants 60 participants
1.06  (0.280) 1.12  (0.289) 1.09  (0)
[1]
Measure Description: 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.
Forced Expiratory Flow 1 sec as a Percentage of Predicted   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of Predicted
Number Analyzed 30 participants 30 participants 60 participants
67.05  (15.22) 71.17  (15.76) 69.11  (0)
[1]
Measure Description: Mean Expiratory Flow 1 second as a Percentage of Predicted
Conway Clinical Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 30 participants 30 participants 60 participants
4.1  (1.4) 4.0  (1.5) 4.05  (0)
[1]
Measure Description: 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.
1.Primary Outcome
Title Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation
Hide Description Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Maximum Expiratory Flow.
Time Frame Baseline,4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual®
Hide Arm/Group Description:
Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
Overall Number of Participants Analyzed 28 24
Mean (Standard Deviation)
Unit of Measure: Liters/minute
44  (26.87) 43.67  (20.48)
2.Primary Outcome
Title Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual®
Hide Arm/Group Description:
Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
Overall Number of Participants Analyzed 28 24
Mean (Standard Deviation)
Unit of Measure: Liters
0.32  (0.2) 0.34  (0.22)
3.Primary Outcome
Title Mean Change in Pulse Oxymetry From Baseline to Final Evaluation
Hide Description 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.
Time Frame Baseline, 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual®
Hide Arm/Group Description:
Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
Overall Number of Participants Analyzed 28 24
Mean (Standard Deviation)
Unit of Measure: percentage
2.57  (1.67) 2.83  (2.51)
4.Primary Outcome
Title Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation
Hide Description 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.
Time Frame Baseline,4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual®
Hide Arm/Group Description:
Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
Overall Number of Participants Analyzed 28 24
Mean (Standard Deviation)
Unit of Measure: score on a scale
-3.18  (1.59) -3.04  (1.83)
5.Secondary Outcome
Title Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events
Hide Description Not posted: see comment in Limitations and Caveats.
Time Frame 4 hours
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Pharmacoeconomic Analysis
Hide Description Pharmacoeconomic analysis comparing the mean direct costs (total cost per prescription) of treatment with Formoterol (Foradil®) to treatment with Fenoterol 0.5 mg + Berodual®.
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual®
Hide Arm/Group Description:
Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
Overall Number of Participants Analyzed 28 24
Mean (Full Range)
Unit of Measure: Cost in US Dollars
9.21
(6.19 to 12.93)
25.67
(21.95 to 29.91)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual®
Hide Arm/Group Description Formoterol (Foradil®) 12 micrograms administered through Aerolizer®. Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
All-Cause Mortality
Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
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.
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 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: External affairs, Novartis
ClinicalTrials.gov Identifier: NCT00460577     History of Changes
Other Study ID Numbers: CFOR258DVE02
First Submitted: April 13, 2007
First Posted: April 16, 2007
Results First Submitted: December 13, 2010
Results First Posted: April 19, 2011
Last Update Posted: April 19, 2011