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    Clinical Trial Results:
    STUDY COMPARING BRONCHODILATOR EFFICACY OF TWO DRY POWDER INHALERS, BUDESONIDE/FORMOTEROL EASYHALER AND SYMBICORT TURBUHALER; A RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, MULTICENTRE, SINGLE DOSE, CROSSOVER STUDY IN ASTHMATIC SUBJECTS

    Summary
    EudraCT number
    		 2014-002705-38
    Trial protocol
    		 HU   BG  
    Global end of trial date
    12 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jun 2016
    First version publication date
    19 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3103013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02308098
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Orion Corporation
    Sponsor organisation address
    Orionintie 1, Espoo, Finland, 02200
    Public contact
    clinicaltrials@orionpharma.com, Orion Corporation Orion Pharma, +358 104261, clinicaltrials@orionpharma.com
    Scientific contact
    clinicaltrials@orionpharma.com, Orion Corporation Orion Pharma, +358 104261, clinicaltrials@orionpharma.com
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the study is to confirm equivalent bronchodilator efficacy of the test product (Budesonide/formoterol Easyhaler) compared to the reference product (Symbicort Turbuhaler).
    Protection of trial subjects
    Safety parameters: (vital signs, 12-lead electrocardiograms, laboratory variables) were assessed, physical examinations were done, and adverse events were recorded.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Dec 2014
    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
    Bulgaria: 48
    Country: Number of subjects enrolled
    Hungary: 24
    Worldwide total number of subjects
    72
    EEA total number of subjects
    72
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    62
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Investigators recruited asthmatic patients from their clinics.

    Pre-assignment
    Screening details
    		 Documented diagnosis of asthma for more than 6 months. Prebronchodilator FEV1 45-90 % of predicted value.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Budesonide/formoterol Easyhaler 9/320 ug one inhalation
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budesonide/formoterol Easyhaler 9/320 ug dry powder inhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    One inhalation as a single dose

    Arm title
    		 Budesonide/formoterol Easyhaler 9/320 ug four inhalations
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budesonide/formoterol Easyhaler 9/320 ug dry powder inhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Four inhalations as a single dose

    Arm title
    		 Symbicort Turbuhaler 9/320 ug one inhalation
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Symbicort Turbuhaler 9/320 ug dry powder inhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    One inhalation as a single dose

    Arm title
    		 Symbicort Turbuhaler 9/320 ug four inhalations
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Symbicort Turbuhaler 9/320 ug dry powder inhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Four inhalations as a single dose

    Number of subjects in period 1
    		Budesonide/formoterol Easyhaler 9/320 ug one inhalation Budesonide/formoterol Easyhaler 9/320 ug four inhalations Symbicort Turbuhaler 9/320 ug one inhalation Symbicort Turbuhaler 9/320 ug four inhalations
    Started
    72
    72
    72
    72
    Completed
    67
    67
    67
    67
    Not completed
    5
    5
    5
    5
         Lack of reproducibility of spirometry
    1
    1
    1
    1
         Lost to follow-up
    2
    2
    2
    2
         Protocol deviation
    2
    2
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 72 72
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 62 62
        Adults (65-84 years)
    		 10 10
    Gender categorical
    Units: Subjects
        Female
    		 46 46
        Male
    		 26 26

    End points

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    End points reporting groups
    Reporting group title
    Budesonide/formoterol Easyhaler 9/320 ug one inhalation
    Reporting group description
    		 -

    Reporting group title
    Budesonide/formoterol Easyhaler 9/320 ug four inhalations
    Reporting group description
    		 -

    Reporting group title
    Symbicort Turbuhaler 9/320 ug one inhalation
    Reporting group description
    		 -

    Reporting group title
    Symbicort Turbuhaler 9/320 ug four inhalations
    Reporting group description
    		 -

    Primary: Average FEV1 between doses

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    End point title
    		 Average FEV1 between doses
    End point description
    End point type
    Primary
    End point timeframe
    0-12 h after dosing
    End point values
    		 Budesonide/formoterol Easyhaler 9/320 ug one inhalation Budesonide/formoterol Easyhaler 9/320 ug four inhalations Symbicort Turbuhaler 9/320 ug one inhalation Symbicort Turbuhaler 9/320 ug four inhalations
    Number of subjects analysed
    53 [1]
    53 [2]
    53 [3]
    53 [4]
    Units: litre(s)
        least squares mean (confidence interval 95%)
    2.324 (2.287 to 2.36)
    2.411 (2.374 to 2.447)
    2.332 (2.295 to 2.368)
    2.419 (2.382 to 2.455)
    Notes
    [1] - PP population
    [2] - PP population
    [3] - PP population
    [4] - PP population
    Statistical analysis title
    		 General linear model
    Comparison groups
    Budesonide/formoterol Easyhaler 9/320 ug one inhalation v Budesonide/formoterol Easyhaler 9/320 ug four inhalations v Symbicort Turbuhaler 9/320 ug one inhalation v Symbicort Turbuhaler 9/320 ug four inhalations
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval

    Primary: Average FEV1 within doses

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    End point title
    		 Average FEV1 within doses
    End point description
    End point type
    Primary
    End point timeframe
    0-12 hours after dosing
    End point values
    		 Budesonide/formoterol Easyhaler 9/320 ug one inhalation Budesonide/formoterol Easyhaler 9/320 ug four inhalations Symbicort Turbuhaler 9/320 ug one inhalation Symbicort Turbuhaler 9/320 ug four inhalations
    Number of subjects analysed
    53 [5]
    53 [6]
    53 [7]
    53 [8]
    Units: litre(s)
        least squares mean (confidence interval 95%)
    2.334 (2.292 to 2.376)
    2.401 (2.359 to 2.44)
    2.321 (2.279 to 2.364)
    2.429 (2.387 to 2.471)
    Notes
    [5] - PP population
    [6] - PP population
    [7] - PP population
    [8] - PP population
    Statistical analysis title
    		 General linear model
    Comparison groups
    Budesonide/formoterol Easyhaler 9/320 ug one inhalation v Symbicort Turbuhaler 9/320 ug one inhalation
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.013
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.047
         upper limit
    		 0.073

    Primary: Average FEV1 within doses 2

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    End point title
    		 Average FEV1 within doses 2 [9]
    End point description
    End point type
    Primary
    End point timeframe
    0-12 hours after dosing
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The comparisons within doses by definition does not include all the arms.
    End point values
    		 Budesonide/formoterol Easyhaler 9/320 ug four inhalations Symbicort Turbuhaler 9/320 ug four inhalations
    Number of subjects analysed
    53 [10]
    53 [11]
    Units: litre(s)
        least squares mean (confidence interval 95%)
    2.401 (2.359 to 2.443)
    2.429 (2.387 to 2.471)
    Notes
    [10] - PP population
    [11] - PP population
    Statistical analysis title
    		 General linear model
    Comparison groups
    Symbicort Turbuhaler 9/320 ug four inhalations v Budesonide/formoterol Easyhaler 9/320 ug four inhalations
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.028
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.087
         upper limit
    		 0.032

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening to end of study visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Budesonide/formoterol Easyhaler 9/320 ug one inhalation
    Reporting group description
    		 -

    Reporting group title
    Budesonide/formoterol Easyhaler 9/320 ug four inhalations
    Reporting group description
    		 -

    Reporting group title
    Symbicort Turbuhaler 9/320 ug one inhalation
    Reporting group description
    		 -

    Reporting group title
    Symbicort Turbuhaler 9/320 ug four inhalations
    Reporting group description
    		 -

    Serious adverse events
    		 Budesonide/formoterol Easyhaler 9/320 ug one inhalation Budesonide/formoterol Easyhaler 9/320 ug four inhalations Symbicort Turbuhaler 9/320 ug one inhalation Symbicort Turbuhaler 9/320 ug four inhalations
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Budesonide/formoterol Easyhaler 9/320 ug one inhalation Budesonide/formoterol Easyhaler 9/320 ug four inhalations Symbicort Turbuhaler 9/320 ug one inhalation Symbicort Turbuhaler 9/320 ug four inhalations
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 68 (2.94%)
    1 / 70 (1.43%)
    3 / 70 (4.29%)
    2 / 68 (2.94%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    1
    0
    General disorders and administration site conditions
    Product taste abnormal
         subjects affected / exposed
    1 / 68 (1.47%)
    1 / 70 (1.43%)
    0 / 70 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    1
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 70 (1.43%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 70 (0.00%)
    2 / 70 (2.86%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Viral infection
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    0
    0
    1

    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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