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    Clinical Trial Results:
    A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter, Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD: GOLDEN-5 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)

    Summary
    EudraCT number
    		 2013-002696-18
    Trial protocol
    		 CZ   HU  
    Global end of trial date
    29 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Aug 2017
    First version publication date
    10 Aug 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SUN101-303
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02276222
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sunovion Respiratory Development Inc.
    Sponsor organisation address
    84 Waterford Drive, Marlboro, United States, 01752
    Public contact
    Respiratory Medical Director, Sunovion Respiratory Development Inc., 1+ 866-503-6351 , ClinicalTrialDisclosure@sunovion.com
    Scientific contact
    Respiratory Medical Director, Sunovion Respiratory Development Inc., 1+ 866-503-6351 , ClinicalTrialDisclosure@sunovion.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
    29 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the long-term safety and tolerability of SUN-101 given as 50 mcg twice daily (BID) over 48 weeks of treatment
    Protection of trial subjects
    The study was conducted according to the protocol, International Council for Harmonisation (ICH) Good Clinical Practice (GCP), ICH guidelines, and the ethical principles that have their origin in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Oct 2014
    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
    Russian Federation: 46
    Country: Number of subjects enrolled
    Czech Republic: 9
    Country: Number of subjects enrolled
    Hungary: 54
    Country: Number of subjects enrolled
    United States: 977
    Worldwide total number of subjects
    1086
    EEA total number of subjects
    63
    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)
    586
    From 65 to 84 years
    500
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects will undergo Screening (Visit 1), including Holter monitoring and assessments to determine study eligibility. Subjects will be provided an electronic diary (eDiary) to record rescue medication use, COPD symptoms, and to complete the EXAcerbations of Chronic Pulmonary Disease Tool (EXACT).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SUN-101 50 mcg BID eFlow (CS) nebulizer
    Arm description
    		 SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
    Arm type
    		 Experimental

    Investigational medicinal product name
    Glycopyrrolate
    Investigational medicinal product code
    Other name
    SUN101
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

    Arm title
    		 Spiriva 18 mcg QD Handihaler
    Arm description
    		 Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
    Arm type
    		 Active comparator

    Investigational medicinal product name
    (tiotropium)
    Investigational medicinal product code
    Other name
    Spiriva
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

    Number of subjects in period 1
    		SUN-101 50 mcg BID eFlow (CS) nebulizer Spiriva 18 mcg QD Handihaler
    Started
    620
    466
    Completed
    436
    402
    Not completed
    184
    64
         Adverse event, serious fatal
    3
    4
         sponsor decision
    -
    3
         Consent withdrawn by subject
    79
    33
         Physician decision
    2
    1
         Adverse event, non-fatal
    62
    11
         non compliance with study medication
    6
    2
         Lost to follow-up
    15
    5
         sheduling conflict
    1
    -
         Lack of efficacy
    13
    3
         Protocol deviation
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SUN-101 50 mcg BID eFlow (CS) nebulizer
    Reporting group description
    		 SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

    Reporting group title
    Spiriva 18 mcg QD Handihaler
    Reporting group description
    		 Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

    Reporting group values
    		 SUN-101 50 mcg BID eFlow (CS) nebulizer Spiriva 18 mcg QD Handihaler Total
    Number of subjects
    		 620 466 1086
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 330 256 586
        >=65 years
    		 290 210 500
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.3 ( 8.46 ) 63.3 ( 8.97 ) -
    Gender categorical
    Units: Subjects
        Female
    		 270 206 476
        Male
    		 350 260 610
    Sex: Female, Male
    Units: Subjects
        Female
    		 270 206 476
        Male
    		 350 260 610
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 9 9 18
        Not Hispanic or Latino
    		 611 457 1068
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 2 2 4
        Asian
    		 1 1 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 35 27 62
        White
    		 582 436 1018
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        Russian Federation
    		 25 21 46
        Czech Republic
    		 5 4 9
        Hungary
    		 34 20 54
        United States
    		 556 421 977
    cardiovascular risk (low/high)
    Units: Subjects
        low cardiovascular risk
    		 219 169 388
        high cardiovascular risk
    		 401 297 698
    background long-acting beta (2) agonist (LABA) use
    Units: Subjects
        background LABA use -yes
    		 267 192 459
        background LABA use -no
    		 353 274 627
    Forced expiratory volume in one second (FEV1)
    Units: liters
        arithmetic mean (standard deviation)
    		 1.3399 ( 0.49604 ) 1.3257 ( 0.50186 ) -

    End points

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    End points reporting groups
    Reporting group title
    SUN-101 50 mcg BID eFlow (CS) nebulizer
    Reporting group description
    		 SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

    Reporting group title
    Spiriva 18 mcg QD Handihaler
    Reporting group description
    		 Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

    Primary: Number of subjects with treatment-emergent adverse events (TEAE)

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    End point title
    		 Number of subjects with treatment-emergent adverse events (TEAE) [1]
    End point description
    A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
    End point type
    Primary
    End point timeframe
    Up to Week 48
    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: No statistical analyses were performed on this endpoint
    End point values
    		 SUN-101 50 mcg BID eFlow (CS) nebulizer Spiriva 18 mcg QD Handihaler
    Number of subjects analysed
    620
    466
    Units: participants
        number (not applicable)
    430
    312
    No statistical analyses for this end point

    Primary: Percentage of subjects with treatment-emergent adverse events

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    End point title
    		 Percentage of subjects with treatment-emergent adverse events [2]
    End point description
    A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
    End point type
    Primary
    End point timeframe
    Up to Week 48
    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: No statistical analyses were performed on this endpoint
    End point values
    		 SUN-101 50 mcg BID eFlow (CS) nebulizer Spiriva 18 mcg QD Handihaler
    Number of subjects analysed
    620
    466
    Units: percentage of participants
        number (not applicable)
    69.4
    67
    No statistical analyses for this end point

    Primary: Number of subjects with treatment-emergent serious adverse events (SAE)

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    End point title
    		 Number of subjects with treatment-emergent serious adverse events (SAE) [3]
    End point description
    A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
    End point type
    Primary
    End point timeframe
    Up to Week 48
    Notes
    [3] - 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: No statistical analyses were performed on this endpoint
    End point values
    		 SUN-101 50 mcg BID eFlow (CS) nebulizer Spiriva 18 mcg QD Handihaler
    Number of subjects analysed
    620
    466
    Units: participants
        number (not applicable)
    76
    49
    No statistical analyses for this end point

    Primary: Percentage of subjects with treatment-emergent serious adverse

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    End point title
    		 Percentage of subjects with treatment-emergent serious adverse [4]
    End point description
    A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
    End point type
    Primary
    End point timeframe
    Up to Week 48
    Notes
    [4] - 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: No statistical analyses were performed on this endpoint
    End point values
    		 SUN-101 50 mcg BID eFlow (CS) nebulizer Spiriva 18 mcg QD Handihaler
    Number of subjects analysed
    620
    466
    Units: percentage of participants
        number (not applicable)
    12.3
    10.5
    No statistical analyses for this end point

    Primary: Number of subjects who discontinue the study due to TEAE

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    End point title
    		 Number of subjects who discontinue the study due to TEAE [5]
    End point description
    A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
    End point type
    Primary
    End point timeframe
    Up to Week 48
    Notes
    [5] - 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: No statistical analyses were performed on this endpoint
    End point values
    		 SUN-101 50 mcg BID eFlow (CS) nebulizer Spiriva 18 mcg QD Handihaler
    Number of subjects analysed
    620
    466
    Units: participants
        number (not applicable)
    62
    13
    No statistical analyses for this end point

    Primary: Percentage of subjects who discontinue the study due to TEAE

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    End point title
    		 Percentage of subjects who discontinue the study due to TEAE [6]
    End point description
    A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
    End point type
    Primary
    End point timeframe
    Up to 48 Weeks
    Notes
    [6] - 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: No statistical analyses were performed on this endpoint
    End point values
    		 SUN-101 50 mcg BID eFlow (CS) nebulizer Spiriva 18 mcg QD Handihaler
    Number of subjects analysed
    620
    466
    Units: percentage of participants
        number (not applicable)
    10
    2.8
    No statistical analyses for this end point

    Secondary: Number of subjects with major adverse cardiac events (MACE), including cardiovascular death, ischemia/infarction, and stroke

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    End point title
    		 Number of subjects with major adverse cardiac events (MACE), including cardiovascular death, ischemia/infarction, and stroke
    End point description
    All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs “myocardial infarction”, “other ischemic heart disease”, “central nervous system hemorrhages and cerebrovascular conditions”) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact.
    End point type
    Secondary
    End point timeframe
    Up to Week 48
    End point values
    		 SUN-101 50 mcg BID eFlow (CS) nebulizer Spiriva 18 mcg QD Handihaler
    Number of subjects analysed
    620
    466
    Units: participants
    number (not applicable)
        MACE score
    3
    8
        cardiovascular death
    1
    2
        non-fatal myocardial infarction
    2
    5
        non-fatal stroke
    0
    1
    No statistical analyses for this end point

    Secondary: Percentage of subjects with major adverse cardiac events (MACE), including cardiovascular death, ischemia/infarction, and stroke

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    End point title
    		 Percentage of subjects with major adverse cardiac events (MACE), including cardiovascular death, ischemia/infarction, and stroke
    End point description
    All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs “myocardial infarction”, “other ischemic heart disease”, “central nervous system hemorrhages and cerebrovascular conditions”) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact.
    End point type
    Secondary
    End point timeframe
    Up to 48 Weeks
    End point values
    		 SUN-101 50 mcg BID eFlow (CS) nebulizer Spiriva 18 mcg QD Handihaler
    Number of subjects analysed
    620
    466
    Units: percentage of participants
    number (not applicable)
        MACE score
    0.5
    1.7
        cardiovascular death
    0.2
    0.4
        non-fatal myocardial infarction
    0.3
    1.1
        non-fatal stroke
    0
    0.2
    No statistical analyses for this end point

    Secondary: Incidence rate per 1000 person years of subjects with major adverse cardiac events (MACE), including cardiovascular death, ischemia/infarction, and stroke

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    End point title
    		 Incidence rate per 1000 person years of subjects with major adverse cardiac events (MACE), including cardiovascular death, ischemia/infarction, and stroke
    End point description
    All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs “myocardial infarction”, “other ischemic heart disease”, “central nervous system hemorrhages and cerebrovascular conditions”) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact.
    End point type
    Secondary
    End point timeframe
    up to week 48
    End point values
    		 SUN-101 50 mcg BID eFlow (CS) nebulizer Spiriva 18 mcg QD Handihaler
    Number of subjects analysed
    620
    466
    Units: incidence rate per 1000 person years
    number (not applicable)
        MACE score
    6.4
    20.3
        cardiovascular death
    2.1
    5.1
        non-fatal myocardial infarction
    4.3
    12.7
        non-fatal stroke
    0
    2.5
    No statistical analyses for this end point

    Secondary: Mean change from baseline over 48 weeks in trough FEV1 for all subjects

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    End point title
    		 Mean change from baseline over 48 weeks in trough FEV1 for all subjects
    End point description
    Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the FEV1 values collected at the end of the dosing interval at each clinic visit. The mean change from baseline in trough FEV1 over the 48 week treatment period is calculated by averaging the trough FEV1 changes from baseline across all study visits while subjects are taking randomized treatment. Values affected by other medication use were to be set to missing.
    End point type
    Secondary
    End point timeframe
    Up to Week 48
    End point values
    		 SUN-101 50 mcg BID eFlow (CS) nebulizer Spiriva 18 mcg QD Handihaler
    Number of subjects analysed
    620
    466
    Units: liters
        least squares mean (standard error)
    0.1016 ( 0.00698 )
    0.0931 ( 0.00779 )
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    SUN-101 50 mcg BID eFlow (CS) nebulizer v Spiriva 18 mcg QD Handihaler
    Number of subjects included in analysis
    1086
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4041
    Method
    		 Least squares mean (SE)
    Parameter type
    		 Least Squares Mean (SE)
    Point estimate
    0.0084
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0114
         upper limit
    		 0.0283
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.01012

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to week 48
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    SUN-101 50 mcg BID eFlow (CS) nebulizer
    Reporting group description
    		 SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

    Reporting group title
    Spiriva 18 mcg QD Handihaler
    Reporting group description
    		 Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler Spiriva® 18 mcg QD Handihaler: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

    Serious adverse events
    		 SUN-101 50 mcg BID eFlow (CS) nebulizer Spiriva 18 mcg QD Handihaler
    Total subjects affected by serious adverse events
         subjects affected / exposed
    76 / 620 (12.26%)
    49 / 466 (10.52%)
         number of deaths (all causes)
    3
    4
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    benign lung neoplasm
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bladder cancer
         subjects affected / exposed
    1 / 620 (0.16%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    breast cancer
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    carcinoid tumor of the apendix
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colon cancer
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    endometrial cancer
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung adenocarcinoma
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    meningioma
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    metastatic renal cell carcinoma
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    non-hodgkins lymphoma
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatic carcinoma
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    prostate cancer
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rectal cancer
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    small cell lung cancer stage unspecified
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    aortic aneurysm
         subjects affected / exposed
    2 / 620 (0.32%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypertension
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General disorders and administration site conditions
    chest pain
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    generalized oedema
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    non-cardiac chest pain
         subjects affected / exposed
    1 / 620 (0.16%)
    2 / 466 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pain
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pyrexia
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    acute respiratory distress syndrome
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    acute respiratory failure
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chronic obstructive pulmonary disease
         subjects affected / exposed
    17 / 620 (2.74%)
    14 / 466 (3.00%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dyspnoea
         subjects affected / exposed
    2 / 620 (0.32%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypoxia
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pleurisy
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia aspiration
         subjects affected / exposed
    2 / 620 (0.32%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumothorax
         subjects affected / exposed
    3 / 620 (0.48%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary embolism
         subjects affected / exposed
    1 / 620 (0.16%)
    2 / 466 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    respiratory failure
         subjects affected / exposed
    1 / 620 (0.16%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pluritic pain
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COPD exacerbation
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    anxiety
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    accidental overdose
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ankle fracture
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hip fracture
         subjects affected / exposed
    3 / 620 (0.48%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    impacted fracture
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    joint injury
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pubis fracture
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    road traffic accident
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subdural haematoma
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vascular pseudoaneurysm
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
         subjects affected / exposed
    1 / 620 (0.16%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    angina pectoris
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrial fibrillation
         subjects affected / exposed
    2 / 620 (0.32%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arterial flutter
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac failure congestive
         subjects affected / exposed
    1 / 620 (0.16%)
    2 / 466 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardio respiratory arrest
         subjects affected / exposed
    3 / 620 (0.48%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    coronary artery disease
         subjects affected / exposed
    3 / 620 (0.48%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myocardial infraction
         subjects affected / exposed
    1 / 620 (0.16%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    verntricular arrhythmia
         subjects affected / exposed
    1 / 620 (0.16%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    hashimoto's encephalopathy
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lumbar radiculopathy
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    multile sclerosis relapse
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    serotonin syndrome
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    syncope
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transient ischaemic attack
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    suicidal ideation
         subjects affected / exposed
    2 / 620 (0.32%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    diplopia
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
         subjects affected / exposed
    1 / 620 (0.16%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colitis
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    constipation
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    duodenal ulcer, obstructive
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastric ulcer haemorrhage
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastric ulcer perforation
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal perforation
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 620 (0.32%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haematochezia
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    large intestinal obstruction
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatitis
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rectal haemorrhage
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    small intestinal obstruction
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholecystitis
         subjects affected / exposed
    2 / 620 (0.32%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cholecystitis acute
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    choleithiasis
         subjects affected / exposed
    2 / 620 (0.32%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    angioedema
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    renal failure
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal mass
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urinary retention
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    back pain
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    joint effsion
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteoarthritis
         subjects affected / exposed
    1 / 620 (0.16%)
    2 / 466 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    abdominal infection
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    appendicitis
         subjects affected / exposed
    1 / 620 (0.16%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bronchitis
         subjects affected / exposed
    2 / 620 (0.32%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastroenteritis
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastronenteritis viral
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteomyelitis
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pheumonia
         subjects affected / exposed
    8 / 620 (1.29%)
    3 / 466 (0.64%)
         occurrences causally related to treatment / all
    2 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    sepsis
         subjects affected / exposed
    0 / 620 (0.00%)
    3 / 466 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    septic shock
         subjects affected / exposed
    0 / 620 (0.00%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    systemic candida
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urinary tract infection
         subjects affected / exposed
    2 / 620 (0.32%)
    1 / 466 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urosepsis
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    dehydration
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypokalaemia
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    malnutrition
         subjects affected / exposed
    1 / 620 (0.16%)
    0 / 466 (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: 5%
    Non-serious adverse events
    		 SUN-101 50 mcg BID eFlow (CS) nebulizer Spiriva 18 mcg QD Handihaler
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    195 / 620 (31.45%)
    133 / 466 (28.54%)
    Respiratory, thoracic and mediastinal disorders
    chronic obstructive pulmonary disease
         subjects affected / exposed
    91 / 620 (14.68%)
    82 / 466 (17.60%)
         occurrences all number
    119
    107
    cough
         subjects affected / exposed
    73 / 620 (11.77%)
    26 / 466 (5.58%)
         occurrences all number
    78
    28
    Infections and infestations
    nasopharyngitis
         subjects affected / exposed
    25 / 620 (4.03%)
    28 / 466 (6.01%)
         occurrences all number
    31
    32
    upper respiratory tract infection
         subjects affected / exposed
    38 / 620 (6.13%)
    25 / 466 (5.36%)
         occurrences all number
    42
    28

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None
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    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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