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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
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