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    Clinical Trial Results:
    A Phase 2, Randomized, Double-Blind, Multiple−Dose, Five−Period, Incomplete-Block, Crossover Study to Examine the Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Multiple Doses of TD−4208 for 7 Days in Subjects Diagnosed With Chronic Obstructive Pulmonary Disease

    Summary
    EudraCT number
    		 2012-004949-32
    Trial protocol
    		 GB   DE  
    Global end of trial date
    23 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Mar 2020
    First version publication date
    22 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0091
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01704404
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Theravance Biopharma R&D, Inc.
    Sponsor organisation address
    901 Gateway Boulevard, South San Francisco, United States, 94080
    Public contact
    Theravance Biopharma R&D, Theravance Biopharma R&D, Inc., 650 808-6000,
    Scientific contact
    Theravance Biopharma R&D, Theravance Biopharma R&D, Inc., 650 808-6000,
    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
    23 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Aug 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to characterize the dose-response curve of TD-4208 after 7 days of dosing in subjects with chronic obstructive pulmonary disease (COPD). The endpoint for this evaluation of TD-4208 was forced expiratory volume in 1 second (FEV1).
    Protection of trial subjects
    The study was conducted in accordance with the principles of the Declaration of Helsinki in place at the time of study conduct. The study was conducted in compliance with the International Conference on Harmonisation (ICH) E6 Guideline for Good Clinical Practice (GCP) (Committee for Proprietary Medicinal Products [CPMP] guideline CPMP/ICH/135/95), and compliant with the European Union Clinical Trial Directive (EU CTD): Directive 2001/20/EC.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Dec 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
    New Zealand: 18
    Country: Number of subjects enrolled
    United Kingdom: 44
    Worldwide total number of subjects
    62
    EEA total number of subjects
    44
    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)
    31
    From 65 to 84 years
    31
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited at 3 sites in the UK and New Zealand.

    Pre-assignment
    Screening details
    		 Participants were screened over a 21-day period.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo once daily for 7 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    The placebo will be administered using a nebulizer as an inhaled solution.

    Arm title
    		 TD-4208 22 μg
    Arm description
    		 Participants received TD-4208 22 μg once daily for 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD−4208
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    TD−4208 will be administered using a nebulizer as an inhaled solution.

    Arm title
    		 TD-4208 44 μg
    Arm description
    		 Participants received TD-4208 44 μg once daily for 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD−4208
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    TD−4208 will be administered using a nebulizer as an inhaled solution.

    Arm title
    		 TD-4208 88 μg
    Arm description
    		 Participants received TD-4208 88 μg once daily for 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD−4208
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    TD−4208 will be administered using a nebulizer as an inhaled solution.

    Arm title
    		 TD-4208 175 μg
    Arm description
    		 Participants received TD-4208 175 μg once daily for 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD−4208
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    TD−4208 will be administered using a nebulizer as an inhaled solution.

    Arm title
    		 TD-4208 350 μg
    Arm description
    		 Participants received TD-4208 350 μg once daily for 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD−4208
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    TD−4208 will be administered using a nebulizer as an inhaled solution.

    Arm title
    		 TD-4208 700 μg
    Arm description
    		 Participants received TD-4208 700 μg once daily for 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD−4208
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    TD−4208 will be administered using a nebulizer as an inhaled solution.

    Number of subjects in period 1
    		Placebo TD-4208 22 μg TD-4208 44 μg TD-4208 88 μg TD-4208 175 μg TD-4208 350 μg TD-4208 700 μg
    Started
    62
    42
    42
    40
    41
    41
    42
    Completed
    55
    36
    37
    37
    35
    38
    37
    Not completed
    7
    6
    5
    3
    6
    3
    5
         Consent withdrawn by subject
    2
    2
    1
    1
    2
    -
    2
         Adverse event, non-fatal
    5
    4
    4
    2
    4
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 62 62
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 31 31
        From 65-84 years
    		 31 31
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 27 27
        Male
    		 35 35
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 2 2
        Not Hispanic or Latino
    		 60 60
    Race
    Units: Subjects
        White
    		 62 62

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo once daily for 7 days.

    Reporting group title
    TD-4208 22 μg
    Reporting group description
    		 Participants received TD-4208 22 μg once daily for 7 days.

    Reporting group title
    TD-4208 44 μg
    Reporting group description
    		 Participants received TD-4208 44 μg once daily for 7 days.

    Reporting group title
    TD-4208 88 μg
    Reporting group description
    		 Participants received TD-4208 88 μg once daily for 7 days.

    Reporting group title
    TD-4208 175 μg
    Reporting group description
    		 Participants received TD-4208 175 μg once daily for 7 days.

    Reporting group title
    TD-4208 350 μg
    Reporting group description
    		 Participants received TD-4208 350 μg once daily for 7 days.

    Reporting group title
    TD-4208 700 μg
    Reporting group description
    		 Participants received TD-4208 700 μg once daily for 7 days.

    Primary: Change from Baseline to Day 7 in Trough Forced Expiratory Volume in 1 Second (FEV1)

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    End point title
    		 Change from Baseline to Day 7 in Trough Forced Expiratory Volume in 1 Second (FEV1)
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Day 7
    End point values
    		 Placebo TD-4208 22 μg TD-4208 44 μg TD-4208 88 μg TD-4208 175 μg TD-4208 350 μg TD-4208 700 μg
    Number of subjects analysed
    59
    40
    39
    39
    39
    39
    40
    Units: mL
        least squares mean (standard error)
    37.8 ( 16.93 )
    91.2 ( 19.21 )
    92.8 ( 20.25 )
    113.1 ( 19.55 )
    151.9 ( 19.99 )
    132.2 ( 19.02 )
    119.4 ( 19.54 )
    Statistical analysis title
    		 Placebo vs. TD-4208 22 μg
    Comparison groups
    Placebo v TD-4208 22 μg
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006 [1]
    Method
    		 Mixed-effects repeated measures model
    Parameter type
    		 LS Mean Difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16.5
         upper limit
    		 90.5
    Notes
    [1] - Adjusted P-value
    Statistical analysis title
    		 Placebo v.s TD-4208 44 μg
    Comparison groups
    TD-4208 44 μg v Placebo
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006 [2]
    Method
    		 Mixed-effects repeated measures model
    Parameter type
    		 LS Mean Difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 15.9
         upper limit
    		 94.1
    Notes
    [2] - Adjusted P-value
    Statistical analysis title
    		 Placebo v.s TD-4208 88 μg
    Comparison groups
    TD-4208 88 μg v Placebo
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.001 [3]
    Method
    		 Mixed-effects repeated measures model
    Parameter type
    		 LS Mean Difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 37.7
         upper limit
    		 113
    Notes
    [3] - Adjusted P-value
    Statistical analysis title
    		 Placebo v.s TD-4208 175 μg
    Comparison groups
    Placebo v TD-4208 175 μg
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [4]
    Method
    		 Mixed-effects repeated measures model
    Parameter type
    		 LS Mean Difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 75.7
         upper limit
    		 152.6
    Notes
    [4] - Adjusted P-value
    Statistical analysis title
    		 Placebo v.s TD-4208 350 μg
    Comparison groups
    Placebo v TD-4208 350 μg
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [5]
    Method
    		 Mixed-effects repeated measures model
    Parameter type
    		 LS Mean Difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 57.7
         upper limit
    		 131.1
    Notes
    [5] - Adjusted P-value
    Statistical analysis title
    		 Placebo v.s TD-4208 700 μg
    Comparison groups
    TD-4208 700 μg v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [6]
    Method
    		 Mixed-effects repeated measures model
    Parameter type
    		 LS Mean Difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 43.8
         upper limit
    		 119.5
    Notes
    [6] - Adjusted P-value

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to End of Follow-up (Up to 14 days after Period 5)
    Adverse event reporting additional description
    Adverse events are reported for the Safety Analysis Set. The Safety analysis set comprised subjects who received at least 1 dose of study treatment (TD-4208 or placebo).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo once daily for 7 days.

    Reporting group title
    TD-4208 22 μg
    Reporting group description
    		 Participants received TD-4208 22 μg once daily for 7 days.

    Reporting group title
    TD-4208 44 μg
    Reporting group description
    		 Participants received TD-4208 44 μg once daily for 7 days.

    Reporting group title
    TD-4208 88 μg
    Reporting group description
    		 Participants received TD-4208 88 μg once daily for 7 days.

    Reporting group title
    TD-4208 175 μg
    Reporting group description
    		 Participants received TD-4208 175 μg once daily for 7 days.

    Reporting group title
    TD-4208 350 μg
    Reporting group description
    		 Participants received TD-4208 350 μg once daily for 7 days.

    Reporting group title
    TD-4208 700 μg
    Reporting group description
    		 Participants received TD-4208 700 μg once daily for 7 days.

    Serious adverse events
    		 Placebo TD-4208 22 μg TD-4208 44 μg TD-4208 88 μg TD-4208 175 μg TD-4208 350 μg TD-4208 700 μg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 61 (1.64%)
    2 / 41 (4.88%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 37 (0.00%)
    0 / 41 (0.00%)
    0 / 37 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Transient ischemic attack
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 37 (0.00%)
    0 / 41 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 37 (0.00%)
    0 / 41 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 37 (0.00%)
    0 / 41 (0.00%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo TD-4208 22 μg TD-4208 44 μg TD-4208 88 μg TD-4208 175 μg TD-4208 350 μg TD-4208 700 μg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 61 (54.10%)
    19 / 41 (46.34%)
    18 / 39 (46.15%)
    19 / 40 (47.50%)
    17 / 37 (45.95%)
    16 / 41 (39.02%)
    14 / 37 (37.84%)
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
    0 / 37 (0.00%)
    0 / 41 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    2 / 40 (5.00%)
    0 / 37 (0.00%)
    0 / 41 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
    0 / 37 (0.00%)
    0 / 41 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 61 (14.75%)
    3 / 41 (7.32%)
    2 / 39 (5.13%)
    3 / 40 (7.50%)
    4 / 37 (10.81%)
    3 / 41 (7.32%)
    5 / 37 (13.51%)
         occurrences all number
    10
    4
    2
    6
    4
    3
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 61 (0.00%)
    2 / 41 (4.88%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
    0 / 37 (0.00%)
    0 / 41 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    2
    3
    0
    0
    0
    0
    Catheter site pain
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
    0 / 37 (0.00%)
    0 / 41 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    2 / 40 (5.00%)
    0 / 37 (0.00%)
    0 / 41 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
    1 / 37 (2.70%)
    0 / 41 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    7
    0
    2
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 61 (1.64%)
    2 / 41 (4.88%)
    1 / 39 (2.56%)
    2 / 40 (5.00%)
    2 / 37 (5.41%)
    2 / 41 (4.88%)
    2 / 37 (5.41%)
         occurrences all number
    1
    2
    1
    2
    2
    2
    2
    Dyspnoea
         subjects affected / exposed
    4 / 61 (6.56%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    1 / 40 (2.50%)
    2 / 37 (5.41%)
    2 / 41 (4.88%)
    1 / 37 (2.70%)
         occurrences all number
    6
    1
    2
    1
    3
    2
    6
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    3 / 40 (7.50%)
    0 / 37 (0.00%)
    0 / 41 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    1
    0
    3
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    1 / 40 (2.50%)
    2 / 37 (5.41%)
    0 / 41 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    1
    1
    2
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 41 (0.00%)
    2 / 39 (5.13%)
    0 / 40 (0.00%)
    1 / 37 (2.70%)
    0 / 41 (0.00%)
    0 / 37 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    0 / 40 (0.00%)
    2 / 37 (5.41%)
    0 / 41 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    1
    0
    2
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 61 (0.00%)
    2 / 41 (4.88%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
    1 / 37 (2.70%)
    1 / 41 (2.44%)
    0 / 37 (0.00%)
         occurrences all number
    0
    4
    0
    2
    2
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Nov 2012
    Changes to the original study protocol reflected in Amendment 1 incorporated additions and changes to the protocol requested by sites participating in the United Kingdom and Germany to comply with local requirements, and to make minor clarifications to the study procedures.
    22 Jan 2013
    Changes to study protocol Amendment 2 incorporated changes requested by the MHRA to require male subjects to continue with contraception for 3 months, rather than 1 month, after the last dose received.
    30 May 2013
    Changes to the original study protocol reflected in Amendment 3 document a change in the Clinical Study Director and Medical Monitor roles from the Sponsor, and correct an editorial discrepancy pertaining to timing of adverse event collection.

    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
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