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    Clinical Trial Results:
    A 24-week, open-label, parallel-group, interventional Phase IV study comparing Tobramycin Inhalation Powder (TIP) administered once daily continuously versus TIP administered BID in 28 day on / 28 day off cycles for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis

    Summary
    EudraCT number
    		 2016-004318-82
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    11 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2017
    First version publication date
    14 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CTBM100CUS03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02015663
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 61321111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 61324111,
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Dec 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To estimate the difference in mean (absolute) change from baseline in forced expiratory volume in 1 second (FEV1) % predicted at Day 168 (Visit 9) with Tobramycin Inhalation Powder (TIP) 112 mg once daily (continuous) vs TIP 112 mg BID in 28 day on / 28 day off cycles.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jan 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
    United States: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    0
    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)
    1
    Adolescents (12-17 years)
    2
    Adults (18-64 years)
    28
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study was discontinued by Novartis on 14-11-2014 due to recruitment challenges. The study intended to randomize 200 patients within 18 months, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%.

    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
    		 Arm 1
    Arm description
    		 Tobramycin Inhalation Powder (112 mg) once daily during 168 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tobramycin Inhalation Powder
    Investigational medicinal product code
    TBM100
    Other name
    Tobramycin
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    112 mg. once daily during 168 days

    Arm title
    		 Arm 2
    Arm description
    		 Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tobramycin Inhalation Powder
    Investigational medicinal product code
    TBM100
    Other name
    Tobramycin
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    112 mg. twice daily on days 1-28, days 57-84 and days 113-140.

    Number of subjects in period 1
    		Arm 1 Arm 2
    Started
    16
    16
    Completed
    1
    4
    Not completed
    15
    12
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    3
    -
         Administrative problems
    10
    11
         unsatisfactory therapeutic effect
    1
    -
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Tobramycin Inhalation Powder (112 mg) once daily during 168 days

    Reporting group title
    Arm 2
    Reporting group description
    		 Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140

    Reporting group values
    		 Arm 1 Arm 2 Total
    Number of subjects
    		 16 16 32
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 1 1
        Adolescents (12-17 years)
    		 1 1 2
        Adults (18-64 years)
    		 14 14 28
        From 65-84 years
    		 1 0 1
        85 years and over
    		 0 0 0
    Age Continuous
    Units: year
        arithmetic mean (standard deviation)
    		 34.9 ± 14.31 26.5 ± 11.09 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 6 8 14
        Male
    		 10 8 18

    End points

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    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Tobramycin Inhalation Powder (112 mg) once daily during 168 days

    Reporting group title
    Arm 2
    Reporting group description
    		 Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140

    Primary: Change from baseline in Forced Expiratory Volume in 1 second ( FEV1) percent predicted

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    End point title
    		 Change from baseline in Forced Expiratory Volume in 1 second ( FEV1) percent predicted [1]
    End point description
    The Forced Expiratory Volume in 1 second (FEV1) percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 percent predicted indicates improvement in lung function.
    End point type
    Primary
    End point timeframe
    Baseline and Day 168
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: percentage of FEV1
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [2] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    [3] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    No statistical analyses for this end point

    Secondary: Percent change from baseline in Forced Expiratory Volume in 1 second (FEV1) percent predicted

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    End point title
    		 Percent change from baseline in Forced Expiratory Volume in 1 second (FEV1) percent predicted
    End point description
    The Forced Expiratory Volume in 1 second (FEV1) percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 percent predicted indicates improvement in lung function.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 168
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: percentage change of FEV1
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [4] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    [5] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    No statistical analyses for this end point

    Secondary: Percent change from baseline in Forced Vital Capacity (FVC) percent predicted

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    End point title
    		 Percent change from baseline in Forced Vital Capacity (FVC) percent predicted
    End point description
    Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 168
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: percentage change of FVC
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [6] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    [7] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    No statistical analyses for this end point

    Secondary: Percent change from baseline in forced expiratory flow (FEF) 25%-75% predicted

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    End point title
    		 Percent change from baseline in forced expiratory flow (FEF) 25%-75% predicted
    End point description
    The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. A positive change from baseline in FEF indicates improvement in lung function. The predicted percent will be assessed.
    End point type
    Secondary
    End point timeframe
    Baseline and day 168
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: percengate change of FEF
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [8] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    [9] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    No statistical analyses for this end point

    Secondary: Change from baseline in Pseudomonas aeruginosa sputum density

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    End point title
    		 Change from baseline in Pseudomonas aeruginosa sputum density
    End point description
    Change from baseline in Pseudomonas aeruginosa sputum density was supposed to be measured by log10 colony forming units per gram of sputum.
    End point type
    Secondary
    End point timeframe
    Baseline and day 168
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: log10 colony forming units per gram of s
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [10] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    [11] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    No statistical analyses for this end point

    Secondary: Time to first hospitalization due to respiratory-related events

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    End point title
    		 Time to first hospitalization due to respiratory-related events
    End point description
    Time to the first hospitalization due to respiratory-related events (number of days) per patient.
    End point type
    Secondary
    End point timeframe
    Day 1 to day 168
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: Days
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [12] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    [13] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    No statistical analyses for this end point

    Secondary: Percentage of patients with hospitalizations due to respiratory-related events

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    End point title
    		 Percentage of patients with hospitalizations due to respiratory-related events
    End point description
    Percentage of patients with hospitalization due to respiratory-related events
    End point type
    Secondary
    End point timeframe
    Day 1 to day 168
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: Percentage of participants
        number (not applicable)
    Notes
    [14] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    [15] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    No statistical analyses for this end point

    Secondary: Length of hospital stay due to respiratory-related events

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    End point title
    		 Length of hospital stay due to respiratory-related events
    End point description
    The number of days in length of hospital stay per patient due to respiratory-related events will be measured.
    End point type
    Secondary
    End point timeframe
    Day 1 to day 168
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    0 [16]
    0 [17]
    Units: Days
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [16] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    [17] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    No statistical analyses for this end point

    Secondary: Time to first usage of anti-pseudomonal antibiotic

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    End point title
    		 Time to first usage of anti-pseudomonal antibiotic
    End point description
    Time to first usage of anti-pseudomonal antibiotic per patient will be assessed by number of days
    End point type
    Secondary
    End point timeframe
    Day 1 to day 168
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    0 [18]
    0 [19]
    Units: Days
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [18] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    [19] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    No statistical analyses for this end point

    Secondary: Percentage of patients who use anti-pseudomonal antibiotic

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    End point title
    		 Percentage of patients who use anti-pseudomonal antibiotic
    End point description
    Percentage of patients who use anti-pseudomonal antibiotic will be assessed.
    End point type
    Secondary
    End point timeframe
    Day 1 to day 168
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    0 [20]
    0 [21]
    Units: Percentage of patients
        number (not applicable)
    Notes
    [20] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    [21] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    No statistical analyses for this end point

    Secondary: Duration of use of anti-pseudomonal antibiotic

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    End point title
    		 Duration of use of anti-pseudomonal antibiotic
    End point description
    Number of days of use of anti-pseudomonal antibiotic per patient will be assessed.
    End point type
    Secondary
    End point timeframe
    Day 1 to day 168
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    0 [22]
    0 [23]
    Units: Days
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [22] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    [23] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    No statistical analyses for this end point

    Secondary: Change from baseline in tobramycin minimal inhibitory concentration for Pseudomonas aeruginosa

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    End point title
    		 Change from baseline in tobramycin minimal inhibitory concentration for Pseudomonas aeruginosa
    End point description
    Change from baseline in tobramycin minimal inhibitory concentration for Pseudomonas aeruginosa will be measured by laboratory testing.
    End point type
    Secondary
    End point timeframe
    Baseline and day 168
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    0 [24]
    0 [25]
    Units: Micrograms/milliliters
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [24] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    [25] - Only safety data analyzed. No data met pre-specified powering of 200 patients needed for analysis.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Tobramycin Inhalation Powder Once Daily
    Reporting group description
    		 Tobramycin Inhalation Powder (112 mg) once daily during 168 days

    Reporting group title
    Tobramycin Inhalation Powder Twice Daily
    Reporting group description
    		 Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140

    Serious adverse events
    		 Tobramycin Inhalation Powder Once Daily Tobramycin Inhalation Powder Twice Daily
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 16 (18.75%)
    1 / 15 (6.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Reproductive system and breast disorders
    Endometriosis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tobramycin Inhalation Powder Once Daily Tobramycin Inhalation Powder Twice Daily
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 16 (81.25%)
    12 / 15 (80.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign ovarian tumour
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 15 (13.33%)
         occurrences all number
    1
    3
    Chest discomfort
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Chills
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Fatigue
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Pain
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Pyrexia
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Fallopian tube cyst
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Haemorrhagic ovarian cyst
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Ovarian cyst
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 16 (62.50%)
    9 / 15 (60.00%)
         occurrences all number
    20
    19
    Dry throat
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Dysphonia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    3
    Dyspnoea
         subjects affected / exposed
    2 / 16 (12.50%)
    3 / 15 (20.00%)
         occurrences all number
    2
    3
    Haemoptysis
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    Nasal congestion
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    3 / 16 (18.75%)
    1 / 15 (6.67%)
         occurrences all number
    3
    3
    Pharyngeal oedema
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Productive cough
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Prolonged expiration
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Pulmonary congestion
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Rhonchi
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Sinus congestion
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    Sputum increased
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 15 (13.33%)
         occurrences all number
    1
    2
    Throat irritation
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Wheezing
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Depression
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Liver function test abnormal
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Pulmonary function test decreased
         subjects affected / exposed
    3 / 16 (18.75%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    Weight decreased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Anaemia postoperative
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorder postoperative
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Vaccination complication
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Nervous system disorders
    Aphonia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Dysgeusia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Neuralgia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Tinnitus
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Constipation
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Dry mouth
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    3
    Nausea
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Post-tussive vomiting
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Vomiting
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Back pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Infections and infestations
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    0 / 16 (0.00%)
    4 / 15 (26.67%)
         occurrences all number
    0
    8
    Otitis media
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (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.
    Due to premature termination, many of the summaries and analyses planned in the protocol were eliminated in the statistical analysis plan prior to database lock. Data were summarized descriptively and no inferential analysis will be provided
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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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