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    Clinical Trial Results:
    MOVE - A randomized, double-blind, placebo-controlled, multicenter, cross-over study to assess the effects of a 3 week therapy each with QVA149 versus placebo on pulmonary function and average physical activity levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD) Due to EudraCT system limitations, which EMA is aware of, results of crossover studies are not accurately represented in this record. Please go to https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.

    Summary
    EudraCT number
    		 2013-001477-25
    Trial protocol
    		 DE  
    Global end of trial date
    11 Feb 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jul 2018
    First version publication date
    12 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CQVA149ADE03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01996319
    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 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
    11 Feb 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate superiority of QVA149 (110/50 μg q.d.) over placebo on peak inspiratory capacity (IC) after 21 days of treatment in patients with moderate to severe COPD.  Co-primary objective was to evaluate whether QVA149 was superior to placebo with respect to average physical activity level as defined by average daily activity-related energy consumption [kcal/day].
    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
    03 Apr 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 194
    Worldwide total number of subjects
    194
    EEA total number of subjects
    194
    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)
    109
    From 65 to 84 years
    85
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 194 were randomized and 194 were exposed to at least one treatment, 96 patients (96/194, 49.5%) were randomized in to the QVA149 - Placebo group and 98 patients (98/194, 50.5%) were randomized into the Placebo - QVA149 group

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 QVA149 then Placebo
    Arm description
    		 QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    QVA149 (110/50 µg
    Investigational medicinal product code
    QVA149
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    single dose dry powder inhaler

    Arm title
    		 Placebo then QVA149
    Arm description
    		 Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo once a day via Breezhaler
    Investigational medicinal product code
    QVA149
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    capsules q.d. for inhalation

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: Disposition table verified
    Number of subjects in period 1
    		QVA149 then Placebo Placebo then QVA149
    Started
    96
    98
    Completed
    88
    95
    Not completed
    8
    3
         Adverse event, non-fatal
    2
    2
         Severe or moderate (COPD) Exacerbation
    5
    1
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    QVA149 then Placebo
    Reporting group description
    		 QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days

    Reporting group title
    Placebo then QVA149
    Reporting group description
    		 Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days

    Reporting group values
    		 QVA149 then Placebo Placebo then QVA149 Total
    Number of subjects
    		 96 98 194
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 42 67 109
        From 65-84 years
    		 54 31 85
        85 years and over
    		 0 0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 64.3 ( 7.9 ) 61.2 ( 7.7 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 32 35 67
        Male
    		 64 63 127

    End points

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    End points reporting groups
    Reporting group title
    QVA149 then Placebo
    Reporting group description
    		 QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days

    Reporting group title
    Placebo then QVA149
    Reporting group description
    		 Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days

    Subject analysis set title
    QVA149
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all randomized patients who applied at least one dose of study medication during at least one study period. all patients were included in these analyses when baseline and day 22 data plus baseline day 36 and day 57 data were available

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all randomized patients who applied at least one dose of study medication during at least one study period. all patients were included in these analyses when baseline and day 22 data plus baseline day 36 and day 57 data were available

    Subject analysis set title
    QVA149
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all randomized patients who applied at least one dose of study medication during at least one study period. all patients were included in these analyses when baseline and day 22 data plus baseline day 36 and day 57 data were available

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all randomized patients who applied at least one dose of study medication during at least one study period. all patients were included in these analyses when baseline and day 22 data plus baseline day 36 and day 57 data were available

    Subject analysis set title
    QVA149
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis

    Subject analysis set title
    QVA149
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis

    Subject analysis set title
    QVA149
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 20 post treatment initiation were included in this analysis.

    Subject analysis set title
    QVA149
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all randomized patients who applied at least one dose of study medication during at least one study period

    Subject analysis set title
    QVA149
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all randomized patients who applied at least one dose of study medication during at least one study period

    Primary: Change from baseline in peak inspiratory capacity (IC) comparison between QVA149 and Placebo

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    End point title
    		 Change from baseline in peak inspiratory capacity (IC) comparison between QVA149 and Placebo
    End point description
    Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36
    End point type
    Primary
    End point timeframe
    Baseline, day 22, baseline day 36, day 57
    End point values
    		 QVA149 Placebo
    Number of subjects analysed
    189
    184
    Units: Liters
        least squares mean (confidence interval 95%)
    0.379 (0.3464 to 0.4117)
    0.1769 (0.1379 to 0.2159)
    Statistical analysis title
    		 Change from baseline in peak inspiratory capacity
    Comparison groups
    Placebo v QVA149
    Number of subjects included in analysis
    373
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 null hypoth
    Point estimate
    0.2021
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1583
         upper limit
    		 0.246

    Primary: Change from baseline in the comparison of QVA149 versus placebo with respect to average physical activity level

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    End point title
    		 Change from baseline in the comparison of QVA149 versus placebo with respect to average physical activity level
    End point description
    Average physical activity level is defined by average daily activity-related energy consumption [Kcal/day], measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36
    End point type
    Primary
    End point timeframe
    Baseline, day 22, baseline day 36, day 57
    End point values
    		 QVA149 Placebo
    Number of subjects analysed
    175
    170
    Units: kcal/day
        least squares mean (confidence interval 95%)
    5.1063 (-24.4 to 34.6125)
    -31.6063 (-61.5268 to -1.6857)
    Statistical analysis title
    		 Change from baseline in the comparison of QVA149
    Statistical analysis description
    Change from baseline in the comparison of QVA149 versus placebo with respect to average physical activity level
    Comparison groups
    QVA149 v Placebo
    Number of subjects included in analysis
    345
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0399
    Method
    		 ANCOVA
    Parameter type
    		 Null hypoth
    Point estimate
    36.7126
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.7241
         upper limit
    		 71.7011

    Secondary: Change in the comparison of QVA149 vs. placebo on the average number of steps per day

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    End point title
    		 Change in the comparison of QVA149 vs. placebo on the average number of steps per day
    End point description
    The average number of steps per day will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day 1 or Day 57-Day36
    End point type
    Secondary
    End point timeframe
    Baseline, day 22, baseline day 36, day 57
    End point values
    		 QVA149 Placebo
    Number of subjects analysed
    178
    173
    Units: Steps/day
        arithmetic mean (standard deviation)
    30.7 ( 1662 )
    -320.7 ( 1648 )
    No statistical analyses for this end point

    Secondary: Change in the Duration of at Least Moderate Activity Per Day Comparison of QVA149 Versus Placebo

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    End point title
    		 Change in the Duration of at Least Moderate Activity Per Day Comparison of QVA149 Versus Placebo
    End point description
    Least moderate activity (defined as 3,5-7kcal/min) will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36
    End point type
    Secondary
    End point timeframe
    Baseline, day 22, baseline day 36, day 57
    End point values
    		 QVA149 Placebo
    Number of subjects analysed
    178
    173
    Units: Minutes
        arithmetic mean (standard deviation)
    -5.5 ( 51.8 )
    -13 ( 52.3 )
    No statistical analyses for this end point

    Secondary: Change from baseline in peak IC comparison between QVA149 and Placebo on day 1.

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    End point title
    		 Change from baseline in peak IC comparison between QVA149 and Placebo on day 1.
    End point description
    Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The IC measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days
    End point type
    Secondary
    End point timeframe
    Day 1 or day 36
    End point values
    		 QVA149 Placebo
    Number of subjects analysed
    193
    186
    Units: Liters
        arithmetic mean (standard deviation)
    0.486 ( 0.2752 )
    0.207 ( 0.2114 )
    No statistical analyses for this end point

    Secondary: Change from baseline in the trough IC comparison between QVA149 and Placebo

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    End point title
    		 Change from baseline in the trough IC comparison between QVA149 and Placebo
    End point description
    Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36
    End point type
    Secondary
    End point timeframe
    Baseline, day 22, baseline day 36, day 57
    End point values
    		 QVA149 Placebo
    Number of subjects analysed
    190
    183
    Units: Liters
        arithmetic mean (standard deviation)
    0.21 ( 0.346 )
    -0.035 ( 0.279 )
    No statistical analyses for this end point

    Secondary: Peak forced expiratory volume 1 (FEV1) comparison between QVA149 and Placebo at day 1

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    End point title
    		 Peak forced expiratory volume 1 (FEV1) comparison between QVA149 and Placebo at day 1
    End point description
    FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The FEV1 measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days
    End point type
    Secondary
    End point timeframe
    Day 1 or day 36
    End point values
    		 Placebo QVA149
    Number of subjects analysed
    186
    192
    Units: Liters
        arithmetic mean (standard deviation)
    0.111 ( 0.179 )
    0.347 ( 0.176 )
    No statistical analyses for this end point

    Secondary: Trough FEV1 comparison between QVA149 and placebo after 22 days

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    End point title
    		 Trough FEV1 comparison between QVA149 and placebo after 22 days
    End point description
    FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the FEV1 measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36
    End point type
    Secondary
    End point timeframe
    Baseline, day 22, baseline day 36, day 57
    End point values
    		 Placebo QVA149
    Number of subjects analysed
    183
    188
    Units: Liters
        arithmetic mean (standard deviation)
    -0.058 ( 0.207 )
    0.245 ( 0.221 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    QVA149
    Reporting group description
    		 QVA149

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 QVA149 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 193 (2.07%)
    2 / 188 (1.06%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bone cancer
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Incisional hernia
         subjects affected / exposed
    1 / 193 (0.52%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 QVA149 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 193 (13.99%)
    19 / 188 (10.11%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 193 (3.11%)
    3 / 188 (1.60%)
         occurrences all number
    7
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 188 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 193 (4.15%)
    3 / 188 (1.60%)
         occurrences all number
    8
    3
    Dyspnoea
         subjects affected / exposed
    2 / 193 (1.04%)
    1 / 188 (0.53%)
         occurrences all number
    2
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 188 (0.00%)
         occurrences all number
    2
    0
    Sputum increased
         subjects affected / exposed
    3 / 193 (1.55%)
    0 / 188 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 193 (1.55%)
    3 / 188 (1.60%)
         occurrences all number
    3
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 193 (3.63%)
    8 / 188 (4.26%)
         occurrences all number
    7
    8
    Rhinitis
         subjects affected / exposed
    2 / 193 (1.04%)
    2 / 188 (1.06%)
         occurrences all number
    2
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 May 2014
    The duration of the treatment was corrected to 21 days. The number of randomized patients was corrected to 190. The exclusion criteria were extended adding that patients with a measured GFR <50 ml/min/1,732 (moderate to severe renal impairment) at visit 1 are excluded from the study. Creatinine clearance measured by GFR (MDRD formula) was added to the list of determined laboratory parameters.

    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.
    Due to EudraCT system limitations, which EMA is aware of, results of crossover studies are not accurately represented in this record. Please go to https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    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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