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    Clinical Trial Results:
    An Open Label Placebo Study To Assess The Inhalation Profile Obtained By Acoustic Monitoring In COPD Patients Using The NEXThaler® Dry Powder Inhaler (DPI) Device.

    Summary
    EudraCT number
    		 2013-000262-11
    Trial protocol
    		 IT  
    Global end of trial date
    26 Jun 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 Jul 2016
    First version publication date
    09 Aug 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of typo error in the Sponsor Protocol Code and correction of Sponsor public and scientific contacts.

    Trial information

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    Trial identification
    Sponsor protocol code
    CCD-01535BC1-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02018549
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Chiesi Farmaceutici S.p.A.
    Sponsor organisation address
    Via Palermo 26/A, Parma, Italy, 43122
    Public contact
    Clinical Trial Transparency, Chiesi Farmaceutici S.p.A., ClinicalTrials_info@chiesi.com
    Scientific contact
    Clinical Trial Transparency, Chiesi Farmaceutici S.p.A., ClinicalTrials_info@chiesi.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
    26 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the inspiration profile through the NEXThaler® device in COPD patients with varying degrees of airflow limitation as per GOLD 2013 (updated) spirometric classification of disease severity.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines and local law requirements . Other than routine care, no specific measures for protection of trial subjects were implemented.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Dec 2013
    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
    Italy: 72
    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)
    23
    From 65 to 84 years
    49
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Seventy-two patients in total were screened and enrolled in the study. Twenty-one patients were in COPD GOLD stage I, 20 in stage II, 21 in stage III and 10 in stage IV. All enrolled patients completed the study.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 NEXThaler® dry powder inhaler with placebo
    Arm description
    		 NEXThaler® dry powder inhaler containing placebo, two inhalations in the morning during the only study visit
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo dry powder,
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    NEXThaler® dry powder inhaler containing placebo two inhalations in the morning during the study visit

    Number of subjects in period 1
    		NEXThaler® dry powder inhaler with placebo
    Started
    72
    Completed
    72

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    NEXThaler® dry powder inhaler with placebo
    Reporting group description
    		 NEXThaler® dry powder inhaler containing placebo, two inhalations in the morning during the only study visit

    Reporting group values
    		 NEXThaler® dry powder inhaler with placebo Total
    Number of subjects
    		 72 72
    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
        Adults (18-64 years)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        From 65-84 years
    		 49 49
        85 years and over
    		 0 0
        Adults 18-64 y
    		 23 23
    Age continuous
    Data are based on per protocol population
    Units: years
        arithmetic mean (standard deviation)
    		 64.9 ± 8.4 -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 60 60
    Subject analysis sets

    Subject analysis set title
    Test treatment, GOLD I - Enrolled/Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received the study medication

    Subject analysis set title
    Test treatment, GOLD II - Enrolled/Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received the study medication

    Subject analysis set title
    Test treatment, GOLD III - Enrolled/Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received the study medication

    Subject analysis set title
    Test treatment, GOLD IV - Enrolled/Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received the study medication

    Subject analysis set title
    Test treatment, GOLD I - Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients from the Safety population excluding patients without any valid evaluation of inhalation profile or with major protocol deviations significantly affecting this assessment

    Subject analysis set title
    Test treatment, GOLD II - Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients from the Safety population excluding patients without any valid evaluation of inhalation profile or with major protocol deviations significantly affecting this assessment

    Subject analysis set title
    Test treatment, GOLD III - Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients from the Safety population excluding patients without any valid evaluation of inhalation profile or with major protocol deviations significantly affecting this assessment

    Subject analysis set title
    Test treatment, GOLD IV - Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients from the Safety population excluding patients without any valid evaluation of inhalation profile or with major protocol deviations significantly affecting this assessment

    Subject analysis sets values
    		 Test treatment, GOLD I - Enrolled/Safety Test treatment, GOLD II - Enrolled/Safety Test treatment, GOLD III - Enrolled/Safety Test treatment, GOLD IV - Enrolled/Safety Test treatment, GOLD I - Per protocol Test treatment, GOLD II - Per protocol Test treatment, GOLD III - Per protocol Test treatment, GOLD IV - Per protocol
    Number of subjects
    21
    20
    21
    10
    19
    20
    20
    10
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Adults (18-64 years)
        Children (2-11 years)
        Adolescents (12-17 years)
        From 65-84 years
        85 years and over
        Adults 18-64 y
    Age continuous
    Data are based on per protocol population
    Units: years
        arithmetic mean (standard deviation)
    64.9 ± 8.4
    68.2 ± 7.3
    70.4 ± 8.2
    67.8 ± 9.5
    64.9 ± 8.4
    68.2 ± 7.3
    70.4 ± 8.2
    67.8 ± 9.5
    Gender categorical
    Units: Subjects
        Female
    8
    2
    2
    0
    7
    2
    2
    0
        Male
    13
    18
    19
    10
    12
    18
    18
    10

    End points

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    End points reporting groups
    Reporting group title
    NEXThaler® dry powder inhaler with placebo
    Reporting group description
    		 NEXThaler® dry powder inhaler containing placebo, two inhalations in the morning during the only study visit

    Subject analysis set title
    Test treatment, GOLD I - Enrolled/Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received the study medication

    Subject analysis set title
    Test treatment, GOLD II - Enrolled/Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received the study medication

    Subject analysis set title
    Test treatment, GOLD III - Enrolled/Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received the study medication

    Subject analysis set title
    Test treatment, GOLD IV - Enrolled/Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received the study medication

    Subject analysis set title
    Test treatment, GOLD I - Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients from the Safety population excluding patients without any valid evaluation of inhalation profile or with major protocol deviations significantly affecting this assessment

    Subject analysis set title
    Test treatment, GOLD II - Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients from the Safety population excluding patients without any valid evaluation of inhalation profile or with major protocol deviations significantly affecting this assessment

    Subject analysis set title
    Test treatment, GOLD III - Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients from the Safety population excluding patients without any valid evaluation of inhalation profile or with major protocol deviations significantly affecting this assessment

    Subject analysis set title
    Test treatment, GOLD IV - Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients from the Safety population excluding patients without any valid evaluation of inhalation profile or with major protocol deviations significantly affecting this assessment

    Primary: Flow at BAM - first inhalation

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    End point title
    		 Flow at BAM - first inhalation [1]
    End point description
    A primary efficacy variable was not defined in the study protocol. "Flow at BAM - first inhalation" was identified as PRIMARY end point for results posting purposes only, so to solve the system ERROR message requiring at least one primary end point in the study. Variables were measured by acoustic monitoring technology through the NEXThaler® during the inspiratory manoeuvre. Only data on the first inhalation are reported here.
    End point type
    Primary
    End point timeframe
    At each of the two inhalations during the only visit
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics has been provided for this end point.
    End point values
    		 Test treatment, GOLD I - Per protocol Test treatment, GOLD II - Per protocol Test treatment, GOLD III - Per protocol Test treatment, GOLD IV - Per protocol
    Number of subjects analysed
    19
    20
    20
    10
    Units: L/min
        arithmetic mean (standard deviation)
    42.9 ± 6.38
    40.27 ± 4.2
    41.05 ± 7.04
    44.76 ± 7.52
    No statistical analyses for this end point

    Other pre-specified: Time to BAM firing

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    End point title
    		 Time to BAM firing
    End point description
    Variables were measured by acoustic monitoring technology through the NEXThaler® during the inspiratory manoeuvre. Only data on the first inhalation are reported here.
    End point type
    Other pre-specified
    End point timeframe
    At each of the two inhalations during the only visit
    End point values
    		 Test treatment, GOLD I - Per protocol Test treatment, GOLD II - Per protocol Test treatment, GOLD III - Per protocol Test treatment, GOLD IV - Per protocol
    Number of subjects analysed
    19
    20
    20
    10
    Units: sec
        arithmetic mean (standard deviation)
    0.17 ± 0.14
    0.17 ± 0.12
    0.18 ± 0.12
    0.2 ± 0.14
    No statistical analyses for this end point

    Other pre-specified: Initial acceleration

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    End point title
    		 Initial acceleration
    End point description
    Variables were measured by acoustic monitoring technology through the NEXThaler® during the inspiratory manoeuvre. Only data on the first inhalation are reported here.
    End point type
    Other pre-specified
    End point timeframe
    At each of the two inhalations during the only visit
    End point values
    		 Test treatment, GOLD I - Per protocol Test treatment, GOLD II - Per protocol Test treatment, GOLD III - Per protocol Test treatment, GOLD IV - Per protocol
    Number of subjects analysed
    19
    20
    20
    10
    Units: L/min/sec
        arithmetic mean (standard deviation)
    155.6 ± 65.5
    140.3 ± 55.1
    140.4 ± 37.4
    158.7 ± 42.4
    No statistical analyses for this end point

    Other pre-specified: PIF

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    End point title
    		 PIF
    End point description
    Variables were measured by acoustic monitoring technology through the NEXThaler® during the inspiratory manoeuvre. Only data on the first inhalation are reported here.
    End point type
    Other pre-specified
    End point timeframe
    At each of the two inhalations during the only visit
    End point values
    		 Test treatment, GOLD I - Per protocol Test treatment, GOLD II - Per protocol Test treatment, GOLD III - Per protocol Test treatment, GOLD IV - Per protocol
    Number of subjects analysed
    19
    20
    20
    10
    Units: L/min
        arithmetic mean (standard deviation)
    74.08 ± 20.79
    69.13 ± 17.67
    63.47 ± 14.96
    63.51 ± 20.15
    No statistical analyses for this end point

    Other pre-specified: Time to PIF

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    End point title
    		 Time to PIF
    End point description
    Variables were measured by acoustic monitoring technology through the NEXThaler® during the inspiratory manoeuvre. Only data on the first inhalation are reported here.
    End point type
    Other pre-specified
    End point timeframe
    At each of the two inhalations during the only visit
    End point values
    		 Test treatment, GOLD I - Per protocol Test treatment, GOLD II - Per protocol Test treatment, GOLD III - Per protocol Test treatment, GOLD IV - Per protocol
    Number of subjects analysed
    19
    20
    20
    10
    Units: sec
        arithmetic mean (standard deviation)
    0.72 ± 0.34
    0.64 ± 0.26
    0.63 ± 0.3
    0.57 ± 0.17
    No statistical analyses for this end point

    Other pre-specified: Total inhaled volume

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    End point title
    		 Total inhaled volume
    End point description
    Variables were measured by acoustic monitoring technology through the NEXThaler® during the inspiratory manoeuvre. Only data on the first inhalation are reported here.
    End point type
    Other pre-specified
    End point timeframe
    At each of the two inhalations during the only visit
    End point values
    		 Test treatment, GOLD I - Per protocol Test treatment, GOLD II - Per protocol Test treatment, GOLD III - Per protocol Test treatment, GOLD IV - Per protocol
    Number of subjects analysed
    19
    20
    20
    10
    Units: liters
        arithmetic mean (standard deviation)
    2.28 ± 0.6
    1.7 ± 0.6
    1.75 ± 0.73
    1.51 ± 0.62
    No statistical analyses for this end point

    Other pre-specified: Total inhalation time

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    End point title
    		 Total inhalation time
    End point description
    Variables were measured by acoustic monitoring technology through the NEXThaler® during the inspiratory manoeuvre. Only data on the first inhalation are reported here.
    End point type
    Other pre-specified
    End point timeframe
    At each of the two inhalations during the only visit
    End point values
    		 Test treatment, GOLD I - Per protocol Test treatment, GOLD II - Per protocol Test treatment, GOLD III - Per protocol Test treatment, GOLD IV - Per protocol
    Number of subjects analysed
    19
    20
    20
    10
    Units: sec
        arithmetic mean (standard deviation)
    2.9 ± 0.68
    2.29 ± 0.6
    2.39 ± 0.79
    2.12 ± 0.8
    No statistical analyses for this end point

    Other pre-specified: FEV1

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    End point title
    		 FEV1
    End point description
    Pulmonary function data are based on spirometry
    End point type
    Other pre-specified
    End point timeframe
    At each of the two inhalations during the only visit
    End point values
    		 Test treatment, GOLD I - Per protocol Test treatment, GOLD II - Per protocol Test treatment, GOLD III - Per protocol Test treatment, GOLD IV - Per protocol
    Number of subjects analysed
    19
    20
    20
    10
    Units: liters
        arithmetic mean (standard deviation)
    2.03 ± 0.45
    1.57 ± 0.47
    1.08 ± 0.22
    0.74 ± 0.2
    No statistical analyses for this end point

    Other pre-specified: FEV1 % predicted

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    End point title
    		 FEV1 % predicted
    End point description
    Pulmonary function data are based on spirometry
    End point type
    Other pre-specified
    End point timeframe
    At each of the two inhalations during the only visit
    End point values
    		 Test treatment, GOLD I - Per protocol Test treatment, GOLD II - Per protocol Test treatment, GOLD III - Per protocol Test treatment, GOLD IV - Per protocol
    Number of subjects analysed
    19
    20
    20
    10
    Units: percent
        arithmetic mean (standard deviation)
    73.4 ± 10.3
    50.5 ± 10.9
    36.5 ± 8.6
    22.4 ± 4.1
    No statistical analyses for this end point

    Other pre-specified: FVC

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    End point title
    		 FVC
    End point description
    Pulmonary function data are based on spirometry
    End point type
    Other pre-specified
    End point timeframe
    At each of the two inhalations during the only visit
    End point values
    		 Test treatment, GOLD I - Per protocol Test treatment, GOLD II - Per protocol Test treatment, GOLD III - Per protocol Test treatment, GOLD IV - Per protocol
    Number of subjects analysed
    19
    20
    20
    10
    Units: liters
        arithmetic mean (standard deviation)
    3.36 ± 0.72
    2.77 ± 0.59
    2.31 ± 0.43
    2.11 ± 0.5
    No statistical analyses for this end point

    Other pre-specified: FVC % predicted

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    End point title
    		 FVC % predicted
    End point description
    Pulmonary function data are based on spirometry
    End point type
    Other pre-specified
    End point timeframe
    At each of the two inhalations during the only visit
    End point values
    		 Test treatment, GOLD I - Per protocol Test treatment, GOLD II - Per protocol Test treatment, GOLD III - Per protocol Test treatment, GOLD IV - Per protocol
    Number of subjects analysed
    19
    20
    20
    10
    Units: percent
        arithmetic mean (standard deviation)
    95.5 ± 10.7
    69.6 ± 8.6
    60 ± 13
    50 ± 12.8
    No statistical analyses for this end point

    Other pre-specified: FEV1/FVC

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    End point title
    		 FEV1/FVC
    End point description
    Pulmonary function data are based on spirometry
    End point type
    Other pre-specified
    End point timeframe
    At each of the two inhalations during the only visit
    End point values
    		 Test treatment, GOLD I - Per protocol Test treatment, GOLD II - Per protocol Test treatment, GOLD III - Per protocol Test treatment, GOLD IV - Per protocol
    Number of subjects analysed
    19
    20
    20
    10
    Units: integer
        arithmetic mean (standard deviation)
    0.61 ± 0.04
    0.56 ± 0.08
    0.47 ± 0.09
    0.36 ± 0.09
    No statistical analyses for this end point

    Other pre-specified: PEF

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    End point title
    		 PEF
    End point description
    Pulmonary function data are based on spirometry
    End point type
    Other pre-specified
    End point timeframe
    At each of the two inhalations during the only visit
    End point values
    		 Test treatment, GOLD I - Per protocol Test treatment, GOLD II - Per protocol Test treatment, GOLD III - Per protocol Test treatment, GOLD IV - Per protocol
    Number of subjects analysed
    19
    20
    20
    10
    Units: L/min
        arithmetic mean (standard deviation)
    365.1 ± 106.7
    292 ± 103.2
    197.3 ± 60.8
    160.9 ± 38.5
    No statistical analyses for this end point

    Other pre-specified: PEF % predicted

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    End point title
    		 PEF % predicted
    End point description
    Pulmonary function data are based on spirometry
    End point type
    Other pre-specified
    End point timeframe
    At each of the two inhalations during the only visit
    End point values
    		 Test treatment, GOLD I - Per protocol Test treatment, GOLD II - Per protocol Test treatment, GOLD III - Per protocol Test treatment, GOLD IV - Per protocol
    Number of subjects analysed
    19
    20
    20
    10
    Units: percent
        arithmetic mean (standard deviation)
    87.1 ± 15.9
    64.4 ± 20.2
    45 ± 12.5
    33.7 ± 7.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    not specified
    Adverse event reporting additional description
    Any adverse events or serious adverse events occurring since the signature of the informed consent were recorded.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Safety population - Test treatment
    Reporting group description
    		 All patients who received the study medication.

    Serious adverse events
    		 Safety population - Test treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 72 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Safety population - Test treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 72 (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: No AEs were reported in this study.

    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.
    No limitations or caveats are applicable to this trial
    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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