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    Clinical Trial Results:
    CORTICO-COP (CORTICOsteroid reduction in COPD) trial

    Summary
    EudraCT number
    		 2015-003441-26
    Trial protocol
    		 DK  
    Global end of trial date
    06 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Dec 2020
    First version publication date
    28 Dec 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Protocol_CORTICO-COP_PSJUJ
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02857842
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    COPTRIN
    Sponsor organisation address
    Kildegårdsvej 28, Hellerup, Denmark, 2900
    Public contact
    Pradeesh Sivapalan, MD, PhD, Lungemedicinsk afdeling, Herlev-Gentofte Hospital, 0045 38674215, pradeesh.s@dadlnet.dk
    Scientific contact
    Pradeesh Sivapalan, MD, PhD, Lungemedicinsk afdeling, Herlev-Gentofte Hospital, 0045 38674215, pradeesh.s@dadlnet.dk
    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
    08 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose is to examine whether we can reduce the accumulated corticosteroid therapy to the individual COPD patient with the aim of reducing the number of corticosteroid-related adverse events.
    Protection of trial subjects
    Monitorering safety data, e.g. all adverse events.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Aug 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Scientific research
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 318
    Worldwide total number of subjects
    318
    EEA total number of subjects
    318
    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)
    0
    From 65 to 84 years
    318
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between Aug 3, 2016, and Sept 30, 2018, we screened 1363 patients. Patients were recruited and followed up between August 2016 and January 2019.

    Pre-assignment
    Screening details
    		 Eligible participants were patients included within 24h of admission to the participating sites, aged at least 40 years, with known airflow limitation (defined as a postbronchodilator FEV₁/forced vital capacity [FVC] ratio ≤0·70) and a specialist-verified diagnosis of COPD, who were designated to start on systemic corticosteroids by the respirat

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control group
    Arm description
    		 This group received standard treatment and 5 days of oral corticosteroids.
    Arm type
    		 Standard care of 5 days oral corticosteorids

    Investigational medicinal product name
    Methylprednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    All patients recruited for the trial received an initial dose of systemic corticosteroidson day 1, followed by 37·5 mg of prednisolone oral tablet daily in 5 days.

    Arm title
    		 Experimental
    Arm description
    		 The eosinophil-guided group were from the second day given 37·5 mg of prednisolone oral tablet daily (for a maximum of up to 4 days) on days when their blood eosinophil count was at least 0·3×10⁹ cells per L. On days when the eosinophil count was lower, prednisolone was not administered.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methylprednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Infusion
    Routes of administration
    Oral use, Intravenous use
    Dosage and administration details
    All patients recruited for the trial received an initial dose of systemic corticosteroidson day 1, followed by 37·5 mg of prednisolone oral tablet daily (for a maximum of up to 4 days) on days when their blood eosinophil count was at least 0·3 × 10⁹ cells per L. On days with eosinophil counts less than 0·3 × 10⁹ cells per L, systemic corticosteroids were not administered.

    Number of subjects in period 1
    		Control group Experimental
    Started
    159
    159
    Completed
    159
    159

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 This group received standard treatment and 5 days of oral corticosteroids.

    Reporting group title
    Experimental
    Reporting group description
    		 The eosinophil-guided group were from the second day given 37·5 mg of prednisolone oral tablet daily (for a maximum of up to 4 days) on days when their blood eosinophil count was at least 0·3×10⁹ cells per L. On days when the eosinophil count was lower, prednisolone was not administered.

    Reporting group values
    		 Control group Experimental Total
    Number of subjects
    		 159 159 318
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 75 (68 to 82) 75 (69 to 81) -
    Gender categorical
    Units: Subjects
        Female
    		 89 86 175
        Male
    		 70 73 143
    Smoking
    Units: Subjects
        Current
    		 50 54 104
        Past
    		 105 103 208
        No smoking history
    		 4 2 6
    Diabetes
    Units: Subjects
        Diabetes
    		 15 24 39
        No diabetes
    		 144 135 279
    Ischaemic heart disease
    Units: Subjects
        Ischaemic heart disease
    		 15 22 37
        No ischaemic heart disease
    		 144 137 281
    Essential hypertension
    Units: Subjects
        Essential hypertension
    		 61 64 125
        No essential hypertension
    		 98 95 193
    Hypercholesterolaemia
    Units: Subjects
        Hypercholesterolaemia
    		 19 19 38
        No hypercholesterolaemia
    		 140 140 280
    Chronic renal failure
    Units: Subjects
        Chronic renal failure
    		 10 12 22
        No chronic renal failure
    		 149 147 296
    Heart failure
    Units: Subjects
        Heart failure
    		 13 17 30
        No heart failure
    		 146 142 288
    Osteoporosis
    Units: Subjects
        Osteoporosis
    		 26 33 59
        No osteoporosis
    		 133 126 259
    Activities of Daily Living
    Units: Subjects
        Score 1-2
    		 127 123 250
        Score 3-5
    		 32 36 68
    Long-acting beta2 agonist
    Medication at baseline
    Units: Subjects
        Long-acting beta2 agonist
    		 127 125 252
        No long-acting beta2 agonist
    		 32 34 66
    Long-acting muscarinic antagonist
    Medication at baseline
    Units: Subjects
        Long-acting muscarinic antagonist
    		 130 118 248
        No long-acting muscarinic antagonist
    		 29 41 70
    Inhaled corticosteroid
    Medication at baseline
    Units: Subjects
        Inhaled corticosteroid
    		 96 80 176
        No inhaled corticosteorid
    		 63 79 142
    Prednisolone prescription 2 weeks before recruitment
    Units: Subjects
        Predisolone prescription
    		 12 8 20
        No prednisolone prescription
    		 147 151 298
    Maintenance cortícosteorid therapy (≤10 mg)
    Units: Subjects
        Maintenance therapy
    		 7 10 17
        No maintenance therapy
    		 152 149 301
    Increased dyspnoea
    Pulmonary function and symptoms at baseline
    Units: Subjects
        Increased dyspnoea
    		 151 146 297
        No increased dyspnoea
    		 8 13 21
    Increased sputum volume
    Pulmonary function and symptoms at baseline
    Units: Subjects
        Increased sputum volume
    		 34 33 67
        No increased sputum volume
    		 125 126 251
    Non-invasive ventilation
    Pulmonary function and symptoms at baseline
    Units: Subjects
        Non-invasive ventilation
    		 5 4 9
        No non-invasive ventilation
    		 154 155 309
    Increased sputum purulence and cough
    Units: Subjects
        Increased sputum purulence and cough
    		 47 45 92
        No increased sputum purulence and cough
    		 112 114 226
    Body-mass index
    Units: kg/m^2
        median (inter-quartile range (Q1-Q3))
    		 23.6 (20.3 to 27.9) 24.2 (20.8 to 26.6) -
    Pack-year history
    Units: pack-years
        median (inter-quartile range (Q1-Q3))
    		 48 (35 to 56) 45 (30 to 57) -
    COPD assesment test
    Units: numbers
        median (inter-quartile range (Q1-Q3))
    		 21 (15 to 26) 21 (17 to 26) -
    Medical Research Council dyspnoea scale
    Units: number
        median (inter-quartile range (Q1-Q3))
    		 4 (3 to 5) 4 (3 to 5) -
    FEV1
    Units: liter
        median (inter-quartile range (Q1-Q3))
    		 0.7 (0.5 to 0.9) 0.7 (0.5 to 0.9) -
    FVC
    Units: liter
        median (inter-quartile range (Q1-Q3))
    		 1.6 (1.2 to 2.1) 1.6 (1.2 to 2.1) -
    FEV1 (% predicted)
    Units: percent
        median (inter-quartile range (Q1-Q3))
    		 30 (23.0 to 40.5) 32 (23.0 to 38.5) -
    FVC (% predicted)
    Units: percent
        median (inter-quartile range (Q1-Q3))
    		 57 (44 to 70) 56 (42 to 72) -

    End points

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    End points reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 This group received standard treatment and 5 days of oral corticosteroids.

    Reporting group title
    Experimental
    Reporting group description
    		 The eosinophil-guided group were from the second day given 37·5 mg of prednisolone oral tablet daily (for a maximum of up to 4 days) on days when their blood eosinophil count was at least 0·3×10⁹ cells per L. On days when the eosinophil count was lower, prednisolone was not administered.

    Primary: Days alive and out of hospital within 14 days after recruitment

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    End point title
    		 Days alive and out of hospital within 14 days after recruitment
    End point description
    Intention-to-treat (n=318)
    End point type
    Primary
    End point timeframe
    14 days
    End point values
    		 Control group Experimental
    Number of subjects analysed
    159
    159
    Units: days
        median (full range (min-max))
    93 (87 to 99)
    89 (83 to 96)
    Statistical analysis title
    		 T-test
    Comparison groups
    Control group v Experimental
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 1-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Secondary: Treatment failure within 30 days

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    End point title
    		 Treatment failure within 30 days
    End point description
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Control group Experimental
    Number of subjects analysed
    159
    159
    Units: patients
    41
    42
    No statistical analyses for this end point

    Secondary: Readmission with acute exacerbation of COPD or death

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    End point title
    		 Readmission with acute exacerbation of COPD or death
    End point description
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Control group Experimental
    Number of subjects analysed
    159
    159
    Units: number
        median (full range (min-max))
    27 (0 to 27)
    39 (0 to 39)
    Statistical analysis title
    		 cox analyiss
    Comparison groups
    Control group v Experimental
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Confidence interval

    Secondary: New onset of diabetes in patients without diabetes by day 30

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    End point title
    		 New onset of diabetes in patients without diabetes by day 30
    End point description
    N = 279
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Control group Experimental
    Number of subjects analysed
    159
    159
    Units: Patients
    6
    6
    No statistical analyses for this end point

    Secondary: Worsening of diabetes control in the diabetes group at day 30

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    End point title
    		 Worsening of diabetes control in the diabetes group at day 30
    End point description
    N = 39
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Control group Experimental
    Number of subjects analysed
    15
    24
    Units: Patients
    10
    2
    No statistical analyses for this end point

    Secondary: Dyspepsia, ulcer complication, or new proton pump inhibitor treatment within 90 days

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    End point title
    		 Dyspepsia, ulcer complication, or new proton pump inhibitor treatment within 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Control group Experimental
    Number of subjects analysed
    159
    159
    Units: Patients
    12
    11
    No statistical analyses for this end point

    Other pre-specified: Length of treatment

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    End point title
    		 Length of treatment
    End point description
    Length of corticosteorid treatment
    End point type
    Other pre-specified
    End point timeframe
    5 days
    End point values
    		 Control group Experimental
    Number of subjects analysed
    159
    159
    Units: days
        median (inter-quartile range (Q1-Q3))
    5.0 (5.0 to 5.0)
    2.0 (1.0 to 3.0)
    No statistical analyses for this end point

    Other pre-specified: Cumulative corticosteorid dose on day 5

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    End point title
    		 Cumulative corticosteorid dose on day 5
    End point description
    End point type
    Other pre-specified
    End point timeframe
    5 days
    End point values
    		 Control group Experimental
    Number of subjects analysed
    159
    159
    Units: mg
        median (inter-quartile range (Q1-Q3))
    225.2 (222.1 to 228.3)
    121.3 (112.7 to 130.0)
    No statistical analyses for this end point

    Other pre-specified: Cumulative corticosteorid dose on day 30

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    End point title
    		 Cumulative corticosteorid dose on day 30
    End point description
    End point type
    Other pre-specified
    End point timeframe
    30 days
    End point values
    		 Control group Experimental
    Number of subjects analysed
    159
    159
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    292.7 (272.2 to 312.7)
    173.8 (151.1 to 196.6)
    No statistical analyses for this end point

    Other pre-specified: Cumulative corticosteorid dose on day 90

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    End point title
    		 Cumulative corticosteorid dose on day 90
    End point description
    End point type
    Other pre-specified
    End point timeframe
    90 days
    End point values
    		 Control group Experimental
    Number of subjects analysed
    159
    159
    Units: mg
    159
    159
    No statistical analyses for this end point

    Other pre-specified: Days alive and out of hospital within 14 days after recruitment in patients without pneumonia

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    End point title
    		 Days alive and out of hospital within 14 days after recruitment in patients without pneumonia
    End point description
    N = 217
    End point type
    Other pre-specified
    End point timeframe
    14 days
    End point values
    		 Control group Experimental
    Number of subjects analysed
    159
    159
    Units: days
    103
    114
    Statistical analysis title
    		 T-test
    Comparison groups
    Control group v Experimental
    Number of subjects included in analysis
    318
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 1-sided
    Parameter type
    		 Median difference (net)
    Confidence interval

    Other pre-specified: Days alive and out of hospital within 14 days after recruitment in patients with pneumonia

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    End point title
    		 Days alive and out of hospital within 14 days after recruitment in patients with pneumonia
    End point description
    N = 101
    End point type
    Other pre-specified
    End point timeframe
    14 days
    End point values
    		 Control group Experimental
    Number of subjects analysed
    159
    159
    Units: days
    45
    56
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    7 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Eosinophil-guided group
    Reporting group description
    		 The eosinophil-guided group were from the second day given 37·5 mg of prednisolone oral tablet daily (for a maximum of up to 4 days) on days when their blood eosinophil count was at least 0·3×10⁹ cells per L. On days when the eosinophil count was lower, prednisolone was not administered.

    Reporting group title
    Control group
    Reporting group description
    		 -

    Serious adverse events
    		 Eosinophil-guided group Control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 159 (7.55%)
    12 / 159 (7.55%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    cardiac arrest
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    supra ventricular tachycardia
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    deep venous thrombosis
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 33
    0 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    dizziness and headache
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    prolonged admission
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-invasive ventilation
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prolonged hospitalization
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary embolism in both lungs
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    readmission
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NIV
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non invasiv ventilation
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prolonged length of hospital stay
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (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
    		 Eosinophil-guided group Control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 159 (9.43%)
    14 / 159 (8.81%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Hypotension
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Cardiac disorders
    Chest pain
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Atrial fibrillation
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Obstipation
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Non-invasive ventilation
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Bronchospasm
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Bloody sputum
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Desaturation
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Itching skin
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Fungal skin infection
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Urineretention
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Haematuria
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Depression
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Restlessness
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Confusional state
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Fall
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Fever
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 159 (0.00%)
         occurrences all number
    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31122894
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