Clinical Trial Results:
Double blind, double dummy, placebo controlled, randomized
study to compare efficacy of Formoterol (Foradil®) Aerolizer®
and Ipratropium Bromide plus Fenoterol (Berodual®)
nebulized, in 5 to 12 year old asthmatic patients being treated
in emergency rooms with symptoms of bronchial obstruction
Summary
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EudraCT number |
2015-004464-11 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
23 Sep 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Nov 2016
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First version publication date |
18 Nov 2016
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CFOR258DVE02
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Novartis Pharma AG
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Sponsor organisation address |
CH 4002, Basel, Switzerland,
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Public contact |
Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
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Scientific contact |
Clinical Study Director, Novartis Pharma AG, 41 613241111,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
23 Sep 2008
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Sep 2008
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To compare the efficacy of two treatment modalities: Fenoterol 0.5 mg plus Ipratropium Bromide, Berodual® (Boeringher Ingelheim Laboratories) nebulized versus Formoterol, Foradil® administered through Aerolizer®, using clinical parameters, Maximum Espiratory Flow or Peek Flow and the One second Forced Espiratory Flow, in pediatric patients being treated in Emergency rooms with bronchial obstruction symptoms
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP)
Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
06 Mar 2007
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Venezuela, Bolivarian Republic of: 60
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Worldwide total number of subjects |
60
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
55
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Adolescents (12-17 years) |
5
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||
Pre-assignment
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Screening details |
This was a multicenter, double-blind, double-dummy, placebo-controlled of parallel groups study of 4 hour duration, assessing and comparing efficacy and tolerability of two treatment schemes in pediatric asthmatic patients being treated in the Emergency room with acute asthma. | |||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Investigator, Subject, Monitor, Carer, Assessor | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Formoterol (Foradil®) | |||||||||||||||
Arm description |
Formoterol (Foradil®) 12 micrograms administered through Aerolizer®. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
formoterol
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
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Dosage and administration details |
formoterol 12 mcg dry powder capsules inhaled via Aerolizer® after measuring inspiratory flow with specific Aerolizer® resistance.
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Arm title
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Fenoterol 0.5 mg + Berodual® | |||||||||||||||
Arm description |
Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized. | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Fenoterol 0.5 mg + Berodual®
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation vapour, liquid
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Routes of administration |
Inhalation use
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Dosage and administration details |
fenoterol, 0.5 mg + Ipratropium Bromide, 0.25 mg delivered by nebulizer;
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Baseline characteristics reporting groups
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Reporting group title |
Formoterol (Foradil®)
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Reporting group description |
Formoterol (Foradil®) 12 micrograms administered through Aerolizer®. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fenoterol 0.5 mg + Berodual®
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Reporting group description |
Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Formoterol (Foradil®)
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Reporting group description |
Formoterol (Foradil®) 12 micrograms administered through Aerolizer®. | ||
Reporting group title |
Fenoterol 0.5 mg + Berodual®
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Reporting group description |
Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized. |
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End point title |
Mean Change in Maximum Expiratory Flow from Baseline to Final Evaluation | ||||||||||||
End point description |
Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Maximum Expiratory Flow.
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End point type |
Primary
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End point timeframe |
Baseline,4 hours
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Statistical analysis title |
MEF | ||||||||||||
Comparison groups |
Formoterol (Foradil®) v Fenoterol 0.5 mg + Berodual®
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Number of subjects included in analysis |
52
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
= 0.673 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
Mean Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to Final Evaluation | ||||||||||||
End point 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.
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End point type |
Primary
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End point timeframe |
Baseline,4 hours
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Statistical analysis title |
FEV1 | ||||||||||||
Comparison groups |
Formoterol (Foradil®) v Fenoterol 0.5 mg + Berodual®
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Number of subjects included in analysis |
52
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
= 0.89 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
Mean Change in Pulse Oxymetry from Baseline to Final Evaluation | ||||||||||||
End point 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.
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End point type |
Primary
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End point timeframe |
Baseline, 4 hours
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Statistical analysis title |
MEF | ||||||||||||
Comparison groups |
Formoterol (Foradil®) v Fenoterol 0.5 mg + Berodual®
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Number of subjects included in analysis |
52
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
= 0.673 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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Statistical analysis title |
Pulse Oximetry | ||||||||||||
Comparison groups |
Formoterol (Foradil®) v Fenoterol 0.5 mg + Berodual®
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Number of subjects included in analysis |
52
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
= 0.985 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
Mean Change in the Conway Clinical Scale Score from Baseline to Final Evaluation | ||||||||||||
End point 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.
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End point type |
Primary
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End point timeframe |
Baseline,4 hours
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Statistical analysis title |
Clinical Scale | ||||||||||||
Comparison groups |
Formoterol (Foradil®) v Fenoterol 0.5 mg + Berodual®
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Number of subjects included in analysis |
52
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
= 0.808 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
Pharmacoeconomic Analysis | ||||||||||||
End point 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®.
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End point type |
Secondary
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End point timeframe |
4 hours
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last
Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV.
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Adverse event reporting additional description |
There were no SAEs or Deaths. No adverse event approached the 5% threshold . Only one AE was recorded for the entire study in the Fomoterol arm of the study. The AE was vomiting and nausea and was not considered drug related.
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Assessment type |
Non-systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
unknown | ||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Formoterol (Foradil®)
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Reporting group description |
Formoterol (Foradil®) 12 micrograms administered through Aerolizer®. | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: only one adverse event occurred and this does not reach the 5% threshold for non serious adverse events reporting |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |