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    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
    EudraCT number
    		 2015-004464-11
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    23 Sep 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Nov 2016
    First version publication date
    18 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CFOR258DVE02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH 4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Study Director, Novartis Pharma AG, 41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Sep 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Sep 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    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
    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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Mar 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Venezuela, Bolivarian Republic of: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    55
    Adolescents (12-17 years)
    5
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    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
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Formoterol (Foradil®)
    Arm description
    		 Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
    Arm type
    		 Experimental

    Investigational medicinal product name
    formoterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    formoterol 12 mcg dry powder capsules inhaled via Aerolizer® after measuring inspiratory flow with specific Aerolizer® resistance.

    Arm title
    		 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®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    fenoterol, 0.5 mg + Ipratropium Bromide, 0.25 mg delivered by nebulizer;

    Number of subjects in period 1
    		Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual®
    Started
    30
    30
    Completed
    28
    24
    Not completed
    2
    6
         Protocol deviation
    2
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Formoterol (Foradil®)
    Reporting group description
    		 Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.

    Reporting group title
    Fenoterol 0.5 mg + Berodual®
    Reporting group description
    		 Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.

    Reporting group values
    		 Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual® Total
    Number of subjects
    		 30 30 60
    Age Categorical
    Units: Subjects
        <=18 years
    		 30 30 60
        Between 18 and 65 years
    		 0 0 0
        >=65 years
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.8 ( 1.5 ) 7.8 ( 2.1 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 12 11 23
        Male
    		 18 19 37
    Study Specific Characteristic | Maximum Inspiratory Flow
    Mean of the Maximum Inspiratory Flow
    Units: Liters/minute
        arithmetic mean (standard deviation)
    		 77.7 ( 16.7 ) 79.9 ( 17.5 ) -
    Study Specific Characteristic | Maximum Expiratory Flow
    Mean of Maximum Expiratory Flow
    Units: Liters/minute
        arithmetic mean (standard deviation)
    		 140.3 ( 33.1 ) 150.3 ( 36.6 ) -
    Study Specific Characteristic | Forced Expiratory Flow 1 sec
    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.
    Units: Liters
        arithmetic mean (standard deviation)
    		 1.06 ( 0.28 ) 1.12 ( 0.289 ) -
    Study Specific Characteristic | Forced Expiratory Flow 1 sec as a Percentage of Predicted
    Mean Expiratory Flow 1 second as a Percentage of Predicted
    Units: Percentage of Predicted
        arithmetic mean (standard deviation)
    		 67.05 ( 15.22 ) 71.17 ( 15.76 ) -
    Study Specific Characteristic | Conway Clinical Scale
    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.
    Units: score on a scale
        arithmetic mean (standard deviation)
    		 4.1 ( 1.4 ) 4 ( 1.5 ) -

    End points

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    End points reporting groups
    Reporting group title
    Formoterol (Foradil®)
    Reporting group description
    		 Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.

    Reporting group title
    Fenoterol 0.5 mg + Berodual®
    Reporting group description
    		 Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.

    Primary: Mean Change in Maximum Expiratory Flow from Baseline to Final Evaluation

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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.
    End point type
    Primary
    End point timeframe
    Baseline,4 hours
    End point values
    		 Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual®
    Number of subjects analysed
    28
    24
    Units: Liters/minute
        arithmetic mean (standard deviation)
    44 ( 26.87 )
    43.67 ( 20.48 )
    Statistical analysis title
    		 MEF
    Comparison groups
    Formoterol (Foradil®) v Fenoterol 0.5 mg + Berodual®
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.673
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Mean Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to Final Evaluation

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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.
    End point type
    Primary
    End point timeframe
    Baseline,4 hours
    End point values
    		 Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual®
    Number of subjects analysed
    28
    24
    Units: Liters
        arithmetic mean (standard deviation)
    0.32 ( 0.2 )
    0.34 ( 0.22 )
    Statistical analysis title
    		 FEV1
    Comparison groups
    Formoterol (Foradil®) v Fenoterol 0.5 mg + Berodual®
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.89
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Mean Change in Pulse Oxymetry from Baseline to Final Evaluation

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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.
    End point type
    Primary
    End point timeframe
    Baseline, 4 hours
    End point values
    		 Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual®
    Number of subjects analysed
    28
    24
    Units: percentage
        arithmetic mean (standard deviation)
    2.57 ( 1.67 )
    2.83 ( 2.51 )
    Statistical analysis title
    		 MEF
    Comparison groups
    Formoterol (Foradil®) v Fenoterol 0.5 mg + Berodual®
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.673
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Pulse Oximetry
    Comparison groups
    Formoterol (Foradil®) v Fenoterol 0.5 mg + Berodual®
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.985
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Mean Change in the Conway Clinical Scale Score from Baseline to Final Evaluation

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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.
    End point type
    Primary
    End point timeframe
    Baseline,4 hours
    End point values
    		 Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual®
    Number of subjects analysed
    28
    24
    Units: score on a scale
        arithmetic mean (standard deviation)
    -3.18 ( 1.59 )
    -3.04 ( 1.83 )
    Statistical analysis title
    		 Clinical Scale
    Comparison groups
    Formoterol (Foradil®) v Fenoterol 0.5 mg + Berodual®
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.808
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Pharmacoeconomic Analysis

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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®.
    End point type
    Secondary
    End point timeframe
    4 hours
    End point values
    		 Formoterol (Foradil®) Fenoterol 0.5 mg + Berodual®
    Number of subjects analysed
    28
    24
    Units: Cost in US Dollars
        arithmetic mean (full range (min-max))
    9.21 (6.19 to 12.93)
    25.67 (21.95 to 29.91)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    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.
    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.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 unknown
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Formoterol (Foradil®)
    Reporting group description
    		 Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.

    Serious adverse events
    		 Formoterol (Foradil®)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Formoterol (Foradil®)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    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

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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