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    Clinical Trial Results:
    Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikayce™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa

    Summary
    EudraCT number
    		 2011-000441-20
    Trial protocol
    		 HU   GB   BE   IE   DE   AT   GR   NL   DK   ES   IT   BG   SK  
    Global end of trial date
    18 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jun 2020
    First version publication date
    13 Jun 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TR02-108
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01315678
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Insmed Incorporated
    Sponsor organisation address
    700 US Highway 202/206, Bridgewater, United States, NJ 08807-1704
    Public contact
    Tom Vanthienen, Insmed Incorporated, +41 795432860, tom.vanthienen@insmed.com
    Scientific contact
    Tom Vanthienen, Insmed Incorporated, +41 795432860, tom.vanthienen@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
    14 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of the study are to evaluate the efficacy, safety and tolerability of 3 cycles (28 days on-treatment and 28 days off treatment) of Arikayce™ therapy.
    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
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Feb 2012
    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
    Netherlands: 4
    Country: Number of subjects enrolled
    Poland: 64
    Country: Number of subjects enrolled
    Slovakia: 15
    Country: Number of subjects enrolled
    Spain: 26
    Country: Number of subjects enrolled
    Sweden: 3
    Country: Number of subjects enrolled
    United Kingdom: 25
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Belgium: 21
    Country: Number of subjects enrolled
    Bulgaria: 36
    Country: Number of subjects enrolled
    Denmark: 8
    Country: Number of subjects enrolled
    France: 24
    Country: Number of subjects enrolled
    Germany: 34
    Country: Number of subjects enrolled
    Greece: 16
    Country: Number of subjects enrolled
    Hungary: 7
    Country: Number of subjects enrolled
    Ireland: 12
    Country: Number of subjects enrolled
    Italy: 49
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    Serbia: 15
    Worldwide total number of subjects
    371
    EEA total number of subjects
    347
    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)
    51
    Adolescents (12-17 years)
    91
    Adults (18-64 years)
    229
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 70 sites in 18 countries.

    Pre-assignment
    Screening details
    		 A total of 371 subjects were screened, of which 302 subjects were randomized. 8 of the randomized subjects were not treated.

    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
    		 Arikayce™
    Arm description
    		 Arikayce™ is liposomal amikacin for inhalation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liposomal amikacin
    Investigational medicinal product code
    Other name
    Arikayce™
    Pharmaceutical forms
    Nebuliser suspension
    Routes of administration
    Inhalation use
    Dosage and administration details
    Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer: Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization. - 590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer. - Administration time is approximately 13 minutes. - Liposomal amikacin for inhalation will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment.

    Arm title
    		 TOBI®
    Arm description
    		 TOBI® is tobramycin inhalation solution.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tobramycin
    Investigational medicinal product code
    Other name
    TOBI®
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Tobramycin inhalation solution using a PARI LC® Plus nebulizer. 300 mg tobramycin inhalation solution is administered twice a day using a PARI LC® Plus nebulizer. - Nebulization time is approximately 20 minutes for each administration. - Tobramycin inhalation solution will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment

    Number of subjects in period 1 [1]
    		Arikayce™ TOBI®
    Started
    148
    146
    Completed
    134
    140
    Not completed
    14
    6
         Consent withdrawn by subject
    7
    3
         Adverse event, non-fatal
    3
    1
         Similar reason to those listed below
    3
    2
         Lost to follow-up
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Worldwide enrollment number includes 69 subjects that were screened but not randomized and 8 subjects that were randomized but not treated. Baseline period includes analysis for the modified intent-to-treat population (mITT; received at least 1 dose of study drug).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arikayce™
    Reporting group description
    		 Arikayce™ is liposomal amikacin for inhalation.

    Reporting group title
    TOBI®
    Reporting group description
    		 TOBI® is tobramycin inhalation solution.

    Reporting group values
    		 Arikayce™ TOBI® Total
    Number of subjects
    		 148 146 294
    Age categorical
    Units: Subjects
        6 - 12 years
    		 27 26 53
        >12 - 18 years
    		 34 33 67
        >18 years
    		 87 87 174
    Gender categorical
    Units: Subjects
        Female
    		 69 70 139
        Male
    		 79 76 155
    Ethnicity
    Units: Subjects
        Caucasian
    		 139 141 280
        Hispanic
    		 5 3 8
        African
    		 1 0 1
        Other
    		 3 1 4
        Not recorded
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Arikayce™
    Reporting group description
    		 Arikayce™ is liposomal amikacin for inhalation.

    Reporting group title
    TOBI®
    Reporting group description
    		 TOBI® is tobramycin inhalation solution.

    Primary: Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1)

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    End point title
    		 Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) [1]
    End point description
    Relative Change (%) from baseline to end of study (Day 168) in FEV1 (1 second).
    End point type
    Primary
    End point timeframe
    Baseline to 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: No additional statistical analysis was planned for this endpoint.
    End point values
    		 Arikayce™ TOBI®
    Number of subjects analysed
    129
    137
    Units: percentage (%) change
        arithmetic mean (standard deviation)
    0.47 ± 13.930
    1.67 ± 16.050
    No statistical analyses for this end point

    Secondary: Pumonary Function Test: Forced Expiratory Volume in 1 Second (FEV1)

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    End point title
    		 Pumonary Function Test: Forced Expiratory Volume in 1 Second (FEV1)
    End point description
    Relative changes (%) from baseline to Study Days 14, 28, 57, 84, 113, 140, 168 in FEV1.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168
    End point values
    		 Arikayce™ TOBI®
    Number of subjects analysed
    148
    146
    Units: percentage (%) change
    arithmetic mean (standard deviation)
        Day 14
    2.59 ± 13.332
    6.64 ± 15.669
        Day 28
    0.79 ± 14.745
    3.32 ± 14.715
        Day 57
    -3.49 ± 12.319
    0.70 ± 14.510
        Day 84
    0.44 ± 14.350
    3.59 ± 14.642
        Day 113
    -0.90 ± 12.028
    0.42 ± 14.434
        Day 140
    0.43 ± 15.299
    1.37 ± 16.563
        Day 168
    -0.12 ± 14.326
    1.58 ± 15.970
    No statistical analyses for this end point

    Secondary: Number of Subjects Experiencing a Pulmonary Exacerbation

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    End point title
    		 Number of Subjects Experiencing a Pulmonary Exacerbation
    End point description
    Number of subjects experiencing a pulmonary exacerbation measured by number with event and number censored.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 168
    End point values
    		 Arikayce™ TOBI®
    Number of subjects analysed
    148
    146
    Units: Subjects
        Number with Event
    73
    63
        Number Censored
    75
    83
    Statistical analysis title
    		 Stratified Cox proportional hazards model
    Comparison groups
    Arikayce™ v TOBI®
    Number of subjects included in analysis
    294
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0286
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    1.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 2.13

    Secondary: Number of Subjects who received Antipseudomonal Antibiotic Treatment for Pulmonary Exacerbation

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    End point title
    		 Number of Subjects who received Antipseudomonal Antibiotic Treatment for Pulmonary Exacerbation
    End point description
    Number of subjects who experienced antipseudomonal antibiotic treatment for pulmonary exacerbation measured by number with event and number censored.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 168
    End point values
    		 Arikayce™ TOBI®
    Number of subjects analysed
    148
    146
    Units: Subjects
        Number with Event
    55
    48
        Number Censored
    93
    98
    Statistical analysis title
    		 Stratified Cox proportional hazards model
    Comparison groups
    Arikayce™ v TOBI®
    Number of subjects included in analysis
    294
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6031
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.66

    Secondary: Number of Subjects who experienced All-Cause Hospitalization

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    End point title
    		 Number of Subjects who experienced All-Cause Hospitalization
    End point description
    Number of subjects with first all cause hospitalization measured by number with event and number censored.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 168
    End point values
    		 Arikayce™ TOBI®
    Number of subjects analysed
    148
    146
    Units: Subjects
        Number with Event
    24
    29
        Number Censored
    124
    117
    Statistical analysis title
    		 Stratified Cox proportional hazards model
    Comparison groups
    Arikayce™ v TOBI®
    Number of subjects included in analysis
    294
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4861
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.44

    Secondary: Change in Density (Log CFU) in Pseudomonas Aeruginosa in Sputum

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    End point title
    		 Change in Density (Log CFU) in Pseudomonas Aeruginosa in Sputum
    End point description
    Change in density (Log CFU) from baseline in Pseudomonas aeruginosa in sputum.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168
    End point values
    		 Arikayce™ TOBI®
    Number of subjects analysed
    148
    146
    Units: Log 10 CFU
    arithmetic mean (standard deviation)
        Baseline
    6.872 ± 1.8806
    6.510 ± 2.3202
        Day 14
    -1.124 ± 2.0542
    -1.663 ± 2.4017
        Day 28
    -1.208 ± 2.1594
    -1.453 ± 2.4440
        Day 57
    -0.210 ± 1.9874
    -0.098 ± 1.7446
        Day 84
    -0.945 ± 2.2223
    -1.182 ± 2.6914
        Day 113
    -0.613 ± 2.1928
    -0.135 ± 2.3461
        Day 140
    -1.440 ± 2.4357
    -1.315 ± 2.2300
        Day 168
    -0.725 ± 2.0073
    -0.136 ± 2.1750
    No statistical analyses for this end point

    Secondary: Relative Percentage (%) Change in Respiratory Symptoms as Measured by the CFQ-R

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    End point title
    		 Relative Percentage (%) Change in Respiratory Symptoms as Measured by the CFQ-R
    End point description
    Quality of Life was measured by the absolute change from baseline in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory scale. Disease specific instrument designed to measure impact on overall health, daily life, perceived well-being and symptoms in patients with a diagnosis of cystic fibrosis. Scores range from 0 to 100, with higher scores indicating better health. Scores for each Health Related Quality of Life (HRQoL) domain; after recoding, each item is summed to generate a domain score and standardized.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168
    End point values
    		 Arikayce™ TOBI®
    Number of subjects analysed
    148
    146
    Units: percentage (%) change
    arithmetic mean (standard error)
        Day 14
    13.65 ± 2.995
    8.81 ± 3.019
        Day 28
    15.54 ± 3.363
    11.03 ± 3.419
        Day 57
    8.00 ± 3.120
    7.97 ± 3.146
        Day 84
    13.20 ± 3.079
    8.55 ± 3.111
        Day 113
    3.58 ± 3.323
    5.03 ± 3.290
        Day 140
    13.84 ± 3.060
    6.10 ± 3.079
        Day 168
    12.06 ± 3.784
    8.07 ± 3.790
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to Day 168
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Arikayce™
    Reporting group description
    		 Arikayce™ is liposomal amikacin for inhalation.

    Reporting group title
    TOBI®
    Reporting group description
    		 TOBI® is tobramycin inhalation solution.

    Serious adverse events
    		 Arikayce™ TOBI®
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 148 (17.57%)
    29 / 146 (19.86%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Forced expiratory volume decreased
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary function test decreased
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Distal intestinal obstruction syndrome
         subjects affected / exposed
    1 / 148 (0.68%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 148 (0.68%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 146 (0.68%)
         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
    Bronchial secretion retention
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 146 (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
    0 / 148 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    24 / 148 (16.22%)
    23 / 146 (15.75%)
         occurrences causally related to treatment / all
    8 / 28
    4 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 148 (0.00%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis allergic
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 146 (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
    		 Arikayce™ TOBI®
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    114 / 148 (77.03%)
    91 / 146 (62.33%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 148 (8.11%)
    5 / 146 (3.42%)
         occurrences all number
    22
    8
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 148 (6.76%)
    5 / 146 (3.42%)
         occurrences all number
    12
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    18 / 148 (12.16%)
    11 / 146 (7.53%)
         occurrences all number
    23
    24
    Dysphonia
         subjects affected / exposed
    18 / 148 (12.16%)
    8 / 146 (5.48%)
         occurrences all number
    28
    9
    Haemoptysis
         subjects affected / exposed
    24 / 148 (16.22%)
    10 / 146 (6.85%)
         occurrences all number
    53
    19
    Oropharyngeal pain
         subjects affected / exposed
    11 / 148 (7.43%)
    6 / 146 (4.11%)
         occurrences all number
    12
    7
    Infections and infestations
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    74 / 148 (50.00%)
    59 / 146 (40.41%)
         occurrences all number
    111
    91
    Nasopharyngitis
         subjects affected / exposed
    24 / 148 (16.22%)
    33 / 146 (22.60%)
         occurrences all number
    29
    43
    Rhinitis
         subjects affected / exposed
    9 / 148 (6.08%)
    9 / 146 (6.16%)
         occurrences all number
    10
    9
    Upper respiratory tract infection
         subjects affected / exposed
    15 / 148 (10.14%)
    9 / 146 (6.16%)
         occurrences all number
    21
    14

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Aug 2011
    Updates were made to the following sections of the protocol: - Clinical experience - Potential risks - Summary of risks/benefits - Study drug - Study evaluations - Assessment of safety - References sections.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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