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    Clinical Trial Results:
    A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Single-Center Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

    Summary
    EudraCT number
    		 2015-001743-36
    Trial protocol
    		 BE  
    Global end of trial date
    26 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Mar 2018
    First version publication date
    03 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PT003018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02643082
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pearl Therapeutics, Inc.
    Sponsor organisation address
    280 Headquarters Plaza, Morristown, United States, 07960
    Public contact
    Pearl Therapeutics, Inc., Pearl Therapeutics, Inc., 1 6503052600, creisner@pearltherapeutics.com
    Scientific contact
    Pearl Therapeutics, Inc., Pearl Therapeutics, Inc., 1 6503052600, creisner@pearltherapeutics.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 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of treatment with GFF MDI, twice daily (BID) compared with Placebo MDI on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) following chronic dosing after approximately two weeks treatment.
    Protection of trial subjects
    For subjects that were on ICS LABA, the ICS LABA was discontinued, however, then prescribed an ICS Monotherapy at an equivalent dosing regimen for the duration of the study. For subjects that were on ICS Monotherapy, they were allowed to continue those medications at the same dose. Ventolin HFA was provided throughout the study for subjects to take as needed for relief of symptoms.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Dec 2015
    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
    Belgium: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    6
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 1 site in Antwerp Belgium from January 2016 to December 2016.The study was anticipated to run for approximately 9 months but not to expected to exceed 12 months. The study period was duration was expected to run approximately 13 weeks for each subject.

    Pre-assignment
    Screening details
    		 Subjects were randomized into 1 of 2 treatment sequences: subjects in Sequence 1 received GFF MDI in Treatment Period 1 followed by Placebo MDI in Treatment Period 2, and subjects in Sequence 2 received Placebo MDI in Treatment Period 1 followed by GFF MDI in Treatment Period 2. By sequence treatment tabulations were not pre-specified

    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
    		 Investigator, Monitor, Subject, Carer, Data analyst, Assessor
    Blinding implementation details
    Study staff were blinded with exception of the Study Pharmacist.

    Arms
    Arm title
    		 Overall Study
    Arm description
    		 All Randomized Patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    Glycopyrronium Formoterol Fumarate MDI
    Investigational medicinal product code
    Other name
    GFF MDI
    Pharmaceutical forms
    Pressurised inhalation, suspension
    Routes of administration
    Inhalation use
    Dosage and administration details
    GFF MDI 14.4/9.6 ug 2 inhalations twice a day

    Investigational medicinal product name
    Placebo MDI
    Investigational medicinal product code
    Other name
    Placebo MDI
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    2 inhalations twice a day

    Number of subjects in period 1
    		Overall Study
    Started
    20
    Treated with GFF MDI 14.4/9.6 μg
    20
    Treated with Placebo MDI
    19
    Completed
    19
    Not completed
    1
         Adverse event, non-fatal
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 All Randomized Patients

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 6 6
        From 65-84 years
    		 14 14
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.8 ( 8.9 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 5 5
        Male
    		 15 15
    Race
    Units: Subjects
        White
    		 20 20
    Subject analysis sets

    Subject analysis set title
    GFF MDI 14.4/9.6 µg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    GFF MDI

    Subject analysis set title
    Placebo MDI
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Placebo

    Subject analysis sets values
    		 GFF MDI 14.4/9.6 µg Placebo MDI
    Number of subjects
    20
    19
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    6
    6
        From 65-84 years
    14
    13
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    64.8 ( 8.7 )
    64.7 ( 9.0 )
    Sex: Female, Male
    Units: Subjects
        Female
        Male
    Race
    Units: Subjects
        White
    20
    19

    End points

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    End points reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 All Randomized Patients

    Subject analysis set title
    GFF MDI 14.4/9.6 µg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    GFF MDI

    Subject analysis set title
    Placebo MDI
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Placebo

    Primary: Specific Airway Volume (siVaw)

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    End point title
    		 Specific Airway Volume (siVaw) [1]
    End point description
    Specific image-based airway volume. Average across lobe, adjusted for lobe volume
    End point type
    Primary
    End point timeframe
    Day 15
    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: Each arm should document the number of subjects who started and the number who completed. However, there is a system limitation at the moment with this option for the reporting of the statistical analysis. There is an automated sum up of the arms population that is performed by the system which is not valid for this option. The result can be reported by omitting the statistical Analysis.
    End point values
    		 Overall Study GFF MDI 14.4/9.6 µg Placebo MDI
    Number of subjects analysed
    20
    20
    19
    Units: mL/L
        geometric mean (confidence interval 95%)
    999999999 (999999999 to 999999999)
    1.79 (1.48 to 2.16)
    1.02 (0.85 to 1.24)
    No statistical analyses for this end point

    Primary: Specific Airway Resistance (siRaw)

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    End point title
    		 Specific Airway Resistance (siRaw) [2]
    End point description
    Specific image-based airway resistance. Average across lobes, adjusted for lobe volume
    End point type
    Primary
    End point timeframe
    Day 15
    Notes
    [2] - 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: Each arm should document the number of subjects who started and the number who completed. However, there is a system limitation at the moment with this option for the reporting of the statistical analysis. There is an automated sum up of the arms population that is performed by the system which is not valid for this option. The result can be reported by omitting the statistical Analysis.
    End point values
    		 Overall Study GFF MDI 14.4/9.6 µg Placebo MDI
    Number of subjects analysed
    20
    20
    19
    Units: kPa s
        geometric mean (confidence interval 95%)
    99999999 (99999999 to 999999999)
    0.09 (0.07 to 0.11)
    0.30 (0.23 to 0.40)
    No statistical analyses for this end point

    Secondary: Airway Resistance (iRaw)

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    End point title
    		 Airway Resistance (iRaw)
    End point description
    iRaw represents the airway resistance, averaged across lobes, without correction for lung lobe volume
    End point type
    Secondary
    End point timeframe
    Day 15
    End point values
    		 Overall Study GFF MDI 14.4/9.6 µg Placebo MDI
    Number of subjects analysed
    20
    20
    19
    Units: kPa s/L
        geometric mean (confidence interval 95%)
    999999999 (999999999 to 999999999)
    0.07 (0.06 to 0.10)
    0.25 (0.19 to 0.33)
    No statistical analyses for this end point

    Secondary: Airway Volume (iVaw)

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    End point title
    		 Airway Volume (iVaw)
    End point description
    iVaw represents the airway Volume, averaged across lobes, without correction for lung lobe volume
    End point type
    Secondary
    End point timeframe
    Day 15
    End point values
    		 Overall Study GFF MDI 14.4/9.6 µg Placebo MDI
    Number of subjects analysed
    20
    20
    19
    Units: mL
        geometric mean (confidence interval 95%)
    999999999 (999999999 to 999999999)
    2.11 (1.73 to 2.58)
    1.18 (0.97 to 1.44)
    No statistical analyses for this end point

    Secondary: Change From Baseline in FEV1 (L) at Day 15

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    End point title
    		 Change From Baseline in FEV1 (L) at Day 15
    End point description
    Change from baseline in Forced Expiratory Volume at 1 second
    End point type
    Secondary
    End point timeframe
    Day 15
    End point values
    		 Overall Study GFF MDI 14.4/9.6 µg Placebo MDI
    Number of subjects analysed
    20
    20
    19
    Units: Liters
        least squares mean (confidence interval 95%)
    999999999 (999999999 to 999999999)
    0.334 (0.245 to 0.422)
    -0.110 (-0.198 to -0.022)
    No statistical analyses for this end point

    Secondary: Ratio to Baseline in FRC (L) at Day 15

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    End point title
    		 Ratio to Baseline in FRC (L) at Day 15
    End point description
    Change from baseline in Functional Residual Capacity
    End point type
    Secondary
    End point timeframe
    Day 15
    End point values
    		 Overall Study GFF MDI 14.4/9.6 µg Placebo MDI
    Number of subjects analysed
    20
    20
    19
    Units: Liters
        geometric mean (confidence interval 95%)
    999999999 (999999999 to 999999999)
    0.90 (0.86 to 0.93)
    1.03 (0.99 to 1.07)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
    Adverse event reporting additional description
    The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 All Randomized Patients

    Reporting group title
    Placebo MDI
    Reporting group description
    		 Placebo

    Reporting group title
    GFF MDI 14.4/9.6 µg
    Reporting group description
    		 GFF MDI

    Serious adverse events
    		 Overall Study Placebo MDI GFF MDI 14.4/9.6 µg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 19 (5.26%)
    1 / 20 (5.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute Myocardial Infarction
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall Study Placebo MDI GFF MDI 14.4/9.6 µg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 20 (75.00%)
    8 / 19 (42.11%)
    12 / 20 (60.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    Acute Myocardial Infarction
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    Bradycardia
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 19 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    0
    2
    Headache
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 19 (5.26%)
    2 / 20 (10.00%)
         occurrences all number
    3
    1
    2
    Tremor
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 19 (5.26%)
    2 / 20 (10.00%)
         occurrences all number
    3
    1
    2
    Dysgeusia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    General disorders and administration site conditions
    Oedema
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 19 (5.26%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    1
    Toothache
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
         subjects affected / exposed
    3 / 20 (15.00%)
    3 / 19 (15.79%)
    0 / 20 (0.00%)
         occurrences all number
    3
    3
    0
    Dyspnoea
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 19 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    0
    2
    Obstructive Airway Disorder
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    Pulmonary Mass
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    2
    0
    2
    Rales
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    Renal and urinary disorders
    Renal Mass
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    Renal Pain
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    Infections and infestations
    Respiratory Tract Infection
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 19 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    0
    2
    Pneumonia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    Metabolism and nutrition disorders
    Iron Defficiency
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0

    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.
    We have provided the mean and 95% CI for each treatment and endpoint. This value is NA and has been entered as 999999999.For all endpoints except FEV1 we input values as Geometric LS Mean however this choice was NA and Geometric Mean was selected.
    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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