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    Clinical Trial Results:
    An Open-Label Safety Extension Study to a Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections Caused By Mycobacterium Avium Complex (MAC) That are Refractory to Treatment

    Summary
    EudraCT number
    		 2015-003170-33
    Trial protocol
    		 DE   GB   AT   ES   PL   NL   SE   IT  
    Global end of trial date
    17 Oct 2018

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 Apr 2023
    First version publication date
    31 Oct 2019
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    INS-312
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02628600
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Insmed Incorporated
    Sponsor organisation address
    700 US Highway 202/206, Bridgewater, NJ, United States, 08807-1704
    Public contact
    Insmed Medical Information, Insmed Incorporated, medicalinformation@insmed.com
    Scientific contact
    Insmed Medical Information, Insmed Incorporated, medicalinformation@insmed.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
    03 May 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate long term safety and tolerability of LAI (590 mg) administered once daily (QD) for up to 12 months in participants who were refractory to standard multi-drug treatment and failed to convert in Study INS-212.
    Protection of trial subjects
    This study was performed in compliance with Good Clinical Practices (GCP), including the archiving of essential documents, the International Council for Harmonisation (ICH) Guidelines, and is consistent with the ethical principles in the Declaration of Helsinki.
    Background therapy
    		 This was a single arm open-label study in which all participants received background multidrug regimen (MDR) composed of an antimycobacterial regimen of at least 2 antibiotics based on the 2007 American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) guidelines or respective local guidelines.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    05 Feb 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Thailand: 1
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    United States: 68
    Country: Number of subjects enrolled
    Australia: 11
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Israel: 3
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Japan: 30
    Country: Number of subjects enrolled
    Korea, Republic of: 8
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    New Zealand: 2
    Country: Number of subjects enrolled
    Poland: 4
    Worldwide total number of subjects
    163
    EEA total number of subjects
    21
    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)
    75
    From 65 to 84 years
    86
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 77 sites in 16 countries. 

    Pre-assignment
    Screening details
    		 Since this study was an open-label extension study to Study INS-212, no pre-specified number of participants was planned. A total of 163 participants (Safety population) were included for the analysis.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prior LAI + Multidrug Regimen
    Arm description
    		 Participants in the prior Study INS-212 who received LAI+MDR. All participants in this safety extension study received LAI+MDR.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liposomal Amikacin for Inhalation
    Investigational medicinal product code
    Other name
    Amikacin Liposome Inhalation Suspension (ALIS), ARIKAYCE
    Pharmaceutical forms
    Nebuliser suspension
    Routes of administration
    Inhalation use
    Dosage and administration details
    LAI 590 mg QD, administered by inhaling drug product that had been aerosolised in an investigational eFlow nebuliser over approximately 14 minutes.

    Arm title
    		 Prior Multidrug Regimen Alone
    Arm description
    		 Participants in the prior Study INS-212 who received MDR alone. All participants in this safety extension study received LAI+MDR.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liposomal Amikacin for Inhalation
    Investigational medicinal product code
    Other name
    Amikacin Liposome Inhalation Suspension (ALIS), ARIKAYCE
    Pharmaceutical forms
    Nebuliser suspension
    Routes of administration
    Inhalation use
    Dosage and administration details
    LAI 590 mg QD, administered by inhaling drug product that had been aerosolised in an investigational eFlow nebulizer over approximately 14 minutes.

    Number of subjects in period 1
    		Prior LAI + Multidrug Regimen Prior Multidrug Regimen Alone
    Started
    73
    90
    Completed
    49
    58
    Not completed
    24
    32
         Adverse event, serious fatal
    2
    1
         Consent withdrawn by subject
    13
    8
         Physician decision
    2
    2
         Adverse event, non-fatal
    3
    20
         Lost to follow-up
    1
    -
         Lack of efficacy
    2
    -
         Other not specified
    1
    -
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Prior LAI + Multidrug Regimen
    Reporting group description
    		 Participants in the prior Study INS-212 who received LAI+MDR. All participants in this safety extension study received LAI+MDR.

    Reporting group title
    Prior Multidrug Regimen Alone
    Reporting group description
    		 Participants in the prior Study INS-212 who received MDR alone. All participants in this safety extension study received LAI+MDR.

    Reporting group values
    		 Prior LAI + Multidrug Regimen Prior Multidrug Regimen Alone Total
    Number of subjects
    		 73 90 163
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 64.9 ( 9.12 ) 64.8 ( 10.33 ) -
    Gender categorical
    Units: Subjects
        Female
    		 51 54 105
        Male
    		 22 36 58

    End points

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    End points reporting groups
    Reporting group title
    Prior LAI + Multidrug Regimen
    Reporting group description
    		 Participants in the prior Study INS-212 who received LAI+MDR. All participants in this safety extension study received LAI+MDR.

    Reporting group title
    Prior Multidrug Regimen Alone
    Reporting group description
    		 Participants in the prior Study INS-212 who received MDR alone. All participants in this safety extension study received LAI+MDR.

    Primary: Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    		 Treatment-Emergent Adverse Events (TEAEs) [1]
    End point description
    TEAEs are defined as those AEs that occurred on or after the date of first dose of study medication in INS-312 and within 28 days after the last dose. If it couldn't be determined whether the AE is treatment emergent due to a partial onset date, then it was classified as treatment emergent.
    End point type
    Primary
    End point timeframe
    Throughout the trial, up to 13 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics are reported.
    End point values
    		 Prior LAI + Multidrug Regimen Prior Multidrug Regimen Alone
    Number of subjects analysed
    73
    90
    Units: Participants
    number (not applicable)
        >=1 TEAE
    68
    90
        >=1 Serious TEAE (sTEAE)
    20
    32
        >=1 TEAE leading to study drug withdrawn
    8
    24
        >=1 TEAE leading to LAI withdrawn
    6
    22
        >=1 TEAE leading to MDR for NTM withdrawn
    4
    8
        >=1 TEAE leading to LAI and MDR for NTM withdrawn
    1
    5
        >=1 sTEAE leading to LAI withdrawn
    3
    9
        >=1 TEAE leading to death
    2
    4
    No statistical analyses for this end point

    Secondary: Number of Participants Achieving Culture Conversion by Month 6 and Month 12

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    End point title
    		 Number of Participants Achieving Culture Conversion by Month 6 and Month 12
    End point description
    6 months: converters are defined as participants who had 3 consecutive monthly MAC-negative sputum cultures by Month 6 (last opportunity to convert was at Month 4) 12 months: converters are defined as participants who had 3 consecutive monthly MAC-negative sputum cultures by Month 12 (last opportunity to convert was at Month 10)
    End point type
    Secondary
    End point timeframe
    6 months, 12 months
    End point values
    		 Prior LAI + Multidrug Regimen Prior Multidrug Regimen Alone
    Number of subjects analysed
    73
    90
    Units: Participants
    number (not applicable)
        6 months
    7
    24
        12 months
    10
    30
    No statistical analyses for this end point

    Secondary: Change from Baseline (Day 1) to Month 6 and Month 12 in the 6MWT Distance

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    End point title
    		 Change from Baseline (Day 1) to Month 6 and Month 12 in the 6MWT Distance
    End point description
    A 6-minute walk assessment of exertional capability was performed as Baseline (Day 1) and Month 6 and Month 12/EOT. The standard protocol based on ATS guidelines was used. After assessments were performed for heart rate, blood pressure, pulse oximetry (SpO2), dyspnoea, and overall fatigue using the Borg scale, participants were instructed to walk on a prescribed course as far as they could in 6 minutes. Pre-test assessment parameters were repeated after exertion. The maximum distance achieved and post exertion heart rate and SpO2 were compared to pre-test values. The maximum distance achieved was recorded in the eCRF.
    End point type
    Secondary
    End point timeframe
    6 months, 12 months
    End point values
    		 Prior LAI + Multidrug Regimen Prior Multidrug Regimen Alone
    Number of subjects analysed
    73
    90
    Units: Meters
    arithmetic mean (standard deviation)
        Baseline
    435.9 ( 132.33 )
    449.0 ( 122.64 )
        Change from Baseline to Month 6
    -10.4 ( 69.77 )
    -20.8 ( 51.57 )
        Change from Baseline to Month 12
    -10.1 ( 79.23 )
    -42.2 ( 72.66 )
    No statistical analyses for this end point

    Secondary: Time to Culture Conversion

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    End point title
    		 Time to Culture Conversion
    End point description
    The time to culture conversion is defined as the date of the first of 3-consecutive monthly negative sputum cultures. Then, the number of days to culture conversion is defined as the difference between the date of conversion and the date of the first dose of LAI. Data were not estimable at 6 and 12 Months due to the proportion of participants achieving conversion.
    End point type
    Secondary
    End point timeframe
    6 months, 12 months
    End point values
    		 Prior LAI + Multidrug Regimen Prior Multidrug Regimen Alone
    Number of subjects analysed
    73
    90
    Units: Months
    median (confidence interval 95%)
        6 Months
    0 (0 to 0)
    0 (0 to 0)
        12 Months
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout trial, up to 13 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Prior Multidrug Regimen Alone
    Reporting group description
    		 Participants in the prior Study INS-212 who received MDR alone. All participants in this safety extension study received LAI+MDR.

    Reporting group title
    Prior LAI + Multidrug Regimen
    Reporting group description
    		 Participants in the prior Study INS-212 who received LAI+MDR. All participants in this safety extension study received LAI+MDR.

    Serious adverse events
    		 Prior Multidrug Regimen Alone Prior LAI + Multidrug Regimen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    32 / 90 (35.56%)
    20 / 73 (27.40%)
         number of deaths (all causes)
    4
    2
         number of deaths resulting from adverse events
    4
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (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
    Hip fracture
         subjects affected / exposed
    0 / 90 (0.00%)
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 90 (2.22%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (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
    0 / 90 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Performance status decreased
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    0 / 90 (0.00%)
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (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
    Interstitial lung disease
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    2 / 90 (2.22%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea at rest
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Alveolitis allergic
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    4 / 90 (4.44%)
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    5 / 7
    0 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Dyspnoea
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 90 (2.22%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 90 (2.22%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung infiltration
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 90 (2.22%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchopulmonary aspergillosis allergic
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinobronchitis
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural pneumonia
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia fungal
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 90 (4.44%)
    3 / 73 (4.11%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycobacterium avium complex infection
         subjects affected / exposed
    5 / 90 (5.56%)
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycobacterium abscessus infection
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Laryngitis
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    3 / 90 (3.33%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Prior Multidrug Regimen Alone Prior LAI + Multidrug Regimen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    75 / 90 (83.33%)
    45 / 73 (61.64%)
    Investigations
    Weight decreased
         subjects affected / exposed
    8 / 90 (8.89%)
    7 / 73 (9.59%)
         occurrences all number
    8
    7
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    13 / 90 (14.44%)
    3 / 73 (4.11%)
         occurrences all number
    13
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    9 / 90 (10.00%)
    5 / 73 (6.85%)
         occurrences all number
    10
    6
    Diarrhoea
         subjects affected / exposed
    9 / 90 (10.00%)
    4 / 73 (5.48%)
         occurrences all number
    11
    5
    Respiratory, thoracic and mediastinal disorders
    Productive cough
         subjects affected / exposed
    6 / 90 (6.67%)
    4 / 73 (5.48%)
         occurrences all number
    6
    5
    Haemoptysis
         subjects affected / exposed
    9 / 90 (10.00%)
    10 / 73 (13.70%)
         occurrences all number
    10
    10
    Dyspnoea
         subjects affected / exposed
    16 / 90 (17.78%)
    9 / 73 (12.33%)
         occurrences all number
    17
    10
    Cough
         subjects affected / exposed
    32 / 90 (35.56%)
    9 / 73 (12.33%)
         occurrences all number
    37
    10
    Dysphonia
         subjects affected / exposed
    39 / 90 (43.33%)
    5 / 73 (6.85%)
         occurrences all number
    54
    6
    Oropharyngeal pain
         subjects affected / exposed
    7 / 90 (7.78%)
    2 / 73 (2.74%)
         occurrences all number
    8
    2
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    5 / 90 (5.56%)
    4 / 73 (5.48%)
         occurrences all number
    6
    4
    Infections and infestations
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    10 / 90 (11.11%)
    6 / 73 (8.22%)
         occurrences all number
    10
    7
    Nasopharyngitis
         subjects affected / exposed
    7 / 90 (7.78%)
    10 / 73 (13.70%)
         occurrences all number
    10
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 May 2017
    The protocol was amended to allow for additional time to analyse primary endpoints due to a longer than anticipated recruitment period and to update administrative and general details.

    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
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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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