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    Clinical Trial Results:
    A randomized, double-blind, repeat dose cross-over study to assess the bronchodilator effects of once daily QVM149 following morning or evening dosing for 14 days compared to placebo in patients with asthma

    Summary
    EudraCT number
    		 2017-000644-17
    Trial protocol
    		 NL   DE   GB  
    Global end of trial date
    24 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Mar 2019
    First version publication date
    10 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CQVM149B2209
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03108027
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Swaziland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Feb 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the potential influence of time of dosing (morning or evening) on the bronchodilator effect of once daily orally inhaled QVM149 compared to placebo
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jun 2017
    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
    Germany: 30
    Country: Number of subjects enrolled
    Netherlands: 7
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    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)
    35
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This was a randomized, placebo-controlled, double-blind, six-sequence, three-period cross-over study in asthma patients. The study consisted of a 14-day screening period, followed by a 14-day run-in period, and three treatment periods.

    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
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence 1
    Arm description
    		 Patients received in a sequential order the following interventional treatments: A,B and C.
    Arm type
    		 Sequence 1

    Investigational medicinal product name
    QVM149 150/50/80 μg
    Investigational medicinal product code
    QVM149
    Other name
    QVM149
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Hard capsule

    Arm title
    		 Sequence 2
    Arm description
    		 Patients received in a sequential order the following interventional treatments: B, A and C.
    Arm type
    		 Sequence 2

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Sequence 3
    Arm description
    		 Patients received in a sequential order the following interventional treatments: C, B and A.
    Arm type
    		 Sequence 3

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Sequence 4
    Arm description
    		 Patients received in a sequential order the following interventional treatments : C, A and B.
    Arm type
    		 Sequence 4

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Sequence 5
    Arm description
    		 Patients received in a sequential order the following interventional treatments: A, C and B.
    Arm type
    		 Sequence 5

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Sequence 6
    Arm description
    		 Patients received in a sequential order the following interventional treatments: B, C and A.
    Arm type
    		 Sequence 6

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Sequence 1 Sequence 2 Sequence 3 Sequence 4 Sequence 5 Sequence 6
    Started
    7
    6
    6
    6
    6
    6
    Completed
    7
    6
    6
    4
    6
    6
    Not completed
    0
    0
    0
    2
    0
    0
         Subject/Guardian Decision
    -
    -
    -
    2
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 37 37
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 35 35
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 43.5 ( 14.04 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 16 16
        Male
    		 21 21
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 0 0
        White
    		 35 35
        More than one race
    		 0 0
        Unknown or Not Reported
    		 2 2
    Subject analysis sets

    Subject analysis set title
    All participants
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants randomized to one of six treatment sequences

    Subject analysis set title
    QVM149 am
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients will receive in a sequential order the following interventional treatments A,B and C

    Subject analysis set title
    QVM149 pm
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients received in a sequential order the following interventional treatments: B, A and C.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients will receive in a sequential order the following interventional treatments: C, B and A.

    Subject analysis set title
    QVM149 am
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients received in a sequential order the following interventional treatments: A,B and C.

    Subject analysis set title
    QVM149 pm
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients received in a sequential order the following interventional treatments: B, A and C.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients received in a sequential order the following interventional treatments: C, B and A.

    Subject analysis sets values
    		 All participants QVM149 am QVM149 pm Placebo QVM149 am QVM149 pm Placebo
    Number of subjects
    37
    30
    30
    33
    35
    35
    36
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    43.5 ( 14.04 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Sex: Female, Male
    Units: Subjects
        Female
    16
        Male
    21
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0
        Asian
    0
        Native Hawaiian or Other Pacific Islander
    0
        Black or African American
    0
        White
    35
        More than one race
    0
        Unknown or Not Reported
    2

    End points

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    End points reporting groups
    Reporting group title
    Sequence 1
    Reporting group description
    		 Patients received in a sequential order the following interventional treatments: A,B and C.

    Reporting group title
    Sequence 2
    Reporting group description
    		 Patients received in a sequential order the following interventional treatments: B, A and C.

    Reporting group title
    Sequence 3
    Reporting group description
    		 Patients received in a sequential order the following interventional treatments: C, B and A.

    Reporting group title
    Sequence 4
    Reporting group description
    		 Patients received in a sequential order the following interventional treatments : C, A and B.

    Reporting group title
    Sequence 5
    Reporting group description
    		 Patients received in a sequential order the following interventional treatments: A, C and B.

    Reporting group title
    Sequence 6
    Reporting group description
    		 Patients received in a sequential order the following interventional treatments: B, C and A.

    Subject analysis set title
    All participants
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants randomized to one of six treatment sequences

    Subject analysis set title
    QVM149 am
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients will receive in a sequential order the following interventional treatments A,B and C

    Subject analysis set title
    QVM149 pm
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients received in a sequential order the following interventional treatments: B, A and C.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients will receive in a sequential order the following interventional treatments: C, B and A.

    Subject analysis set title
    QVM149 am
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients received in a sequential order the following interventional treatments: A,B and C.

    Subject analysis set title
    QVM149 pm
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients received in a sequential order the following interventional treatments: B, A and C.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients received in a sequential order the following interventional treatments: C, B and A.

    Primary: FEV1 standardized Area Under the Curve (AUC 0-24h) after last evening dose of 14-day treatment period

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    End point title
    		 FEV1 standardized Area Under the Curve (AUC 0-24h) after last evening dose of 14-day treatment period
    End point description
    Weighted mean forced expiratory volume in 1 second (FEV1) over 24 h (AUC0-24h) following 14 days of treatment with QVM149 dosed in the morning, QVM149 dosed in the evening and placebo.
    End point type
    Primary
    End point timeframe
    At the end of each treatment period day 14 pre-dose to 24 hours post-dose.
    End point values
    		 QVM149 am QVM149 pm Placebo
    Number of subjects analysed
    30
    30
    33
    Units: Liters
        least squares mean (standard error)
    3.4305 ( 0.15242 )
    3.4361 ( 0.15213 )
    2.8209 ( 0.15259 )
    Statistical analysis title
    		 Treatment difference
    Statistical analysis description
    A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’
    Comparison groups
    QVM149 am v Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Linear mixed model
    Point estimate
    0.6096
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.538
         upper limit
    		 0.6811
    Notes
    [1] - Treatment difference
    Statistical analysis title
    		 Treatment difference
    Statistical analysis description
    A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’
    Comparison groups
    QVM149 pm v Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Mixed models analysis
    Parameter type
    		 A hypothesis test is not planned for thi
    Point estimate
    0.6152
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.5437
         upper limit
    		 0.6868
    Statistical analysis title
    		 treatment difference
    Statistical analysis description
    A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’
    Comparison groups
    QVM149 am v QVM149 pm
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Mixed models analysis
    Parameter type
    		 A hypothesis test is not planned for thi
    Point estimate
    -0.0057
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.076
         upper limit
    		 0.0647

    Secondary: Trough FEV1 after 24h

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    End point title
    		 Trough FEV1 after 24h
    End point description
    FEV1 at approximately 24 h after the last p.m. or penultimate a.m. dose. Morning and evening trough FEV1 (L) were analyzed by time of day. For morning trough FEV1 (L) assessments this meant that the spirometric assessment was done approximately 24 h after last morning dose and approximately 12 h after last evening dose.
    End point type
    Secondary
    End point timeframe
    At the end of each treatment period day 14 pre-dose to 24 hours post-dose.
    End point values
    		 QVM149 am QVM149 pm Placebo
    Number of subjects analysed
    35
    35
    36
    Units: Liters
    least squares mean (standard error)
        Morning trough FEV1
    3.3731 ( 0.15037 )
    3.4871 ( 0.15041 )
    2.7524 ( 1.15120 )
    Statistical analysis title
    		 Treatment difference
    Statistical analysis description
    A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’
    Comparison groups
    QVM149 am v Placebo
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.6206
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.5335
         upper limit
    		 0.7077
    Notes
    [2] - Treatment difference
    Statistical analysis title
    		 Treatment difference
    Statistical analysis description
    A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’
    Comparison groups
    QVM149 pm v Placebo
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Mixed models analysis
    Parameter type
    		 A hypothesis test is not planned for thi
    Point estimate
    0.7347
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.6469
         upper limit
    		 0.8225
    Statistical analysis title
    		 Treatment difference
    Statistical analysis description
    A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’
    Comparison groups
    QVM149 am v QVM149 pm
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Mixed models analysis
    Parameter type
    		 A hypothesis test is not planned for thi
    Point estimate
    -0.1141
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.197
         upper limit
    		 -0.0311

    Secondary: Peak expiratory flow (PEF)

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    End point title
    		 Peak expiratory flow (PEF)
    End point description
    Peak expiratory flow (PEF) is the maximum flow generated during a forceful exhalation, starting from full lung inflationDaily morning and evening peak expiratory flow rate from Day 2 to Day14 during the three treatment periods.
    End point type
    Secondary
    End point timeframe
    From treatment period start through study completion (up to 19 weeks).
    End point values
    		 QVM149 am QVM149 pm Placebo
    Number of subjects analysed
    35
    35
    36
    Units: L/min
    least squares mean (standard error)
        Morning average PEF
    489.6 ( 19.77 )
    504.4 ( 19.78 )
    417.5 ( 19.73 )
        Evening average PEF
    522.0 ( 19.71 )
    507.7 ( 19.71 )
    449.0 ( 19.67 )
    Statistical analysis title
    		 Morning average PEF
    Statistical analysis description
    A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.
    Comparison groups
    QVM149 am v Placebo
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    		 Mixed models analysis
    Parameter type
    		 Linear mixed model
    Point estimate
    72.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 61.3
         upper limit
    		 82.9
    Notes
    [3] - Treatment difference
    Statistical analysis title
    		 Morning average PEF
    Statistical analysis description
    A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’
    Comparison groups
    QVM149 pm v Placebo
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Mixed models analysis
    Parameter type
    		 A hypothesis test is not planned for thi
    Point estimate
    86.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 76.1
         upper limit
    		 97.8
    Statistical analysis title
    		 Morning average PEF
    Statistical analysis description
    A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’
    Comparison groups
    QVM149 am v QVM149 pm
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Mixed models analysis
    Parameter type
    		 A hypothesis test is not planned for thi
    Point estimate
    -14.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -25.6
         upper limit
    		 -4.1
    Statistical analysis title
    		 Evening average PEF
    Comparison groups
    QVM149 am v Placebo
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    		 Mixed models analysis
    Parameter type
    		 A hypothesis test is not planned for thi
    Point estimate
    73.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 61.9
         upper limit
    		 84.2
    Notes
    [4] - A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’
    Statistical analysis title
    		 Evening average PEF
    Comparison groups
    QVM149 pm v Placebo
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    Method
    		 Mixed models analysis
    Parameter type
    		 A hypothesis test is not planned for thi
    Point estimate
    58.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 47.5
         upper limit
    		 69.9
    Notes
    [5] - A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.
    Statistical analysis title
    		 Evening average PEF
    Comparison groups
    QVM149 am v QVM149 pm
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    Method
    		 Mixed models analysis
    Parameter type
    		 A hypothesis test is not planned for thi
    Point estimate
    14.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 3.3
         upper limit
    		 25.5
    Notes
    [6] - A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    QVM149
    Reporting group description
    		 QVM149 morning dose

    Reporting group title
    QVM149
    Reporting group description
    		 QVM149 evening dose

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 QVM149 QVM149 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 QVM149 QVM149 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 35 (31.43%)
    13 / 35 (37.14%)
    16 / 36 (44.44%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 35 (14.29%)
    3 / 35 (8.57%)
    7 / 36 (19.44%)
         occurrences all number
    5
    3
    7
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 35 (5.71%)
    1 / 36 (2.78%)
         occurrences all number
    1
    2
    1
    Dysphonia
         subjects affected / exposed
    2 / 35 (5.71%)
    3 / 35 (8.57%)
    1 / 36 (2.78%)
         occurrences all number
    2
    3
    1
    Oropharyngeal pain
         subjects affected / exposed
    3 / 35 (8.57%)
    4 / 35 (11.43%)
    2 / 36 (5.56%)
         occurrences all number
    3
    4
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 35 (5.71%)
    5 / 36 (13.89%)
         occurrences all number
    2
    2
    6

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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