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    Clinical Trial Results:
    A double-blind, randomized, placebo-controlled cross-over study of inhaled alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis.

    Summary
    EudraCT number
    		 2014-000844-13
    Trial protocol
    		 DK   SE   DE  
    Global end of trial date
    05 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jul 2020
    First version publication date
    23 Jul 2020
    Other versions
    Summary report(s)
    		 Study synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    SMR-2984
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02157922
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Algipharma AS
    Sponsor organisation address
    Industrivn. 33, Sandvika, Norway, 1337
    Public contact
    Yngvar Berg, CEO, Algipharma AS, +47 90044903, yngvar.berg@algipharma.com
    Scientific contact
    Anne M Graver, Clinical Trial Manager, Algipharma AS, +47 93041021, anne.graver@algipharma.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
    12 Sep 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    05 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Demonstrate efficacy of inhaled OligoG measured by FEV-1 and supported by secondary endpoints including Mucociliary Clearance, rheology, microbiology, Quality-of-Life (CF-QR), and Lung Clearance Index (LCI)
    Protection of trial subjects
    A Drug Safety Monitoring Board assessed unblinded data throughout the study to ensure prompt action in case of safety concerns.
    Background therapy
    		 Standard of Care. The patient are allowed to continue other CF treatment as long as this has been ongoing in a stable fashion the past 21 days prior to randomization.
    Evidence for comparator
    		 The use of placebo as a comparator is a naturally design in order to evaluate safety, tolerability and preliminary efficacy in patients with cystic fibrosis (CF). Matching placebo DPI, where the OligoG is replaced with lactose, approx. 48 mg in HPMC capsules. The placebo DPI capsules will be indistinguishable from OligoG in appearance, smell, taste and packaging.
    Actual start date of recruitment
    30 Dec 2014
    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
    Sweden: 5
    Country: Number of subjects enrolled
    United Kingdom: 20
    Country: Number of subjects enrolled
    Denmark: 6
    Country: Number of subjects enrolled
    Germany: 32
    Country: Number of subjects enrolled
    Norway: 2
    Worldwide total number of subjects
    65
    EEA total number of subjects
    65
    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)
    65
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Ninety patients were screened and 65 were randomised. Of the randomised patients, 56 completed two 28 day treatment periods separated by a 28-day washout period. 33 patients completed the OligoG-Placebo period, and 32 completed the placebo-OligoG period. Nine patients withdrew, 8 due to non-fatal AEs, and 1 is lost to follow-up.

    Pre-assignment
    Screening details
    		 Ability to inhale the IMP

    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, Data analyst, Carer, Assessor
    Blinding implementation details
    The IMP (OligoG DPI or placebo DPI) in identical capsules

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 OligoG-Placebo DPI
    Arm description
    		 OligoG for 28 days, then 4 weeks wash-out, then Placebo DPI for 28 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    OligoG-PlaceboDPI (Cross-over)
    Investigational medicinal product code
    OligoG-Placebo DPI (cross-over)
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Ten capsules were taken by the study subjects three times daily to deliver a total daily dose of 1050 mg OligoG/Placebo DPI.

    Arm title
    		 Placebo DPI-OligoG
    Arm description
    		 Placebo DPI for 28 days, then 4 weeks wash-out, and then OligoG for 28 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo DPI-OligoG (cross-over)
    Investigational medicinal product code
    Placebo DPI-OligoG (cross-over)
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Ten capsules were taken by the study subjects three times daily to deliver a total daily dose of equivalent to 1050 mg OligoG/Placebo DPI.

    Number of subjects in period 1
    		OligoG-Placebo DPI Placebo DPI-OligoG
    Started
    32
    33
    Completed
    27
    29
    Not completed
    5
    4
         Adverse event, non-fatal
    4
    4
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 These are all patients together in both groups prior to wash-out, i.e OligoG and Palcebo combined.

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 65 65
    Age categorical
    All 65 patients were in adult age category (age 18 - 64)
    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)
    		 65 65
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        adults
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 34 34
        Male
    		 31 31
    Subject analysis sets

    Subject analysis set title
    All patients
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects caucasian Mean age 33,5 years. Range 19 - 59 31 male, 34 female

    Subject analysis sets values
    		 All patients
    Number of subjects
    65
    Age categorical
    All 65 patients were in adult age category (age 18 - 64)
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    65
        From 65-84 years
    0
        85 years and over
    0
        adults
    0
    Age continuous
    OligoG: 31.8 (10.3) Placebo: 35.3 (8.9)
    Units: years
        arithmetic mean (standard deviation)
    ( )
    Gender categorical
    Units: Subjects
        Female
    34
        Male
    31

    End points

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    End points reporting groups
    Reporting group title
    OligoG-Placebo DPI
    Reporting group description
    		 OligoG for 28 days, then 4 weeks wash-out, then Placebo DPI for 28 days

    Reporting group title
    Placebo DPI-OligoG
    Reporting group description
    		 Placebo DPI for 28 days, then 4 weeks wash-out, and then OligoG for 28 days.

    Subject analysis set title
    All patients
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects caucasian Mean age 33,5 years. Range 19 - 59 31 male, 34 female

    Primary: The treatment difference OligoG – Placebo in FEV1

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    End point title
    		 The treatment difference OligoG – Placebo in FEV1
    End point description
    The FEV1 values at the end of each treatment period will be examined with analysis of covariance (ANCOVA), using treatment, treatment period and treatment sequence as fixed effects, patient as random effect and the baseline FEV1 values in each period as covariates. Of the 56 patients who completed the study, one patient is withdrawn for the analysis due to missing data.
    End point type
    Primary
    End point timeframe
    Change in FEV1 from start of each treatment period to Day 28 of treatment
    End point values
    		 OligoG-Placebo DPI Placebo DPI-OligoG All patients
    Number of subjects analysed
    27 [1]
    29 [2]
    56 [3]
    Units: % improvement
        number (confidence interval 95%)
    0 (0 to 0)
    0 (0 to 0)
    -0.013 (-0.038 to 0.012)
    Notes
    [1] - Number of patients who completed treatment sequence OligoG-Placebo DPI
    [2] - Number of patients who completed treatment sequence Placebo DPI-OligoG
    [3] - Of the 56 patients who completed the study, one patient is withdrawn due to missing data.
    Statistical analysis title
    		 Statistical analysis
    Statistical analysis description
    The primary efficacy variable for the study was forced expiratory volume in one second (FEV1). The primary analysis was performed on the ITT population. Forthe FEV1 values at the end of each treatment period, a linear model was constructed using SAS PROC MIXED, with treatment, treatment sequence and treatment period as fixed effects, patients as random effects and the baseline value in each treatment period as a covariate.
    Comparison groups
    OligoG-Placebo DPI v Placebo DPI-OligoG
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.31 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.013
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.038
         upper limit
    		 0.012
    Notes
    [4] - The treatment difference was found to be 1.3% units in favour of placebo, and the difference was not statistically significant.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected and reported throughout the study; sequence 1, washout, and sequence 2.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    OligoG
    Reporting group description
    		 Number of patients combined receiving OligoG either in the first treatment period or second treatment period.

    Reporting group title
    Placebo DPI
    Reporting group description
    		 Number of patients combined receiving placebo either in the first treatment period or second treatment period.

    Serious adverse events
    		 OligoG Placebo DPI
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 63 (11.11%)
    8 / 61 (13.11%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Blood potassium increased
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hospitalisation
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (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
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rales
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (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
    Pulmonary exacerbation
         subjects affected / exposed
    4 / 63 (6.35%)
    4 / 61 (6.56%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         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
    1 / 63 (1.59%)
    0 / 61 (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 / 63 (0.00%)
    1 / 61 (1.64%)
         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
    		 OligoG Placebo DPI
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 63 (82.54%)
    51 / 61 (83.61%)
    Surgical and medical procedures
    Hospitalisation
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Chest discomfort
         subjects affected / exposed
    3 / 63 (4.76%)
    2 / 61 (3.28%)
         occurrences all number
    3
    2
    Chest pain
         subjects affected / exposed
    2 / 63 (3.17%)
    4 / 61 (6.56%)
         occurrences all number
    2
    5
    Chills
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Crepitations
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 61 (1.64%)
         occurrences all number
    2
    1
    Energy increased
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 61 (1.64%)
         occurrences all number
    2
    1
    Influenza like illness
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    0
    2
    Pyrexia
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 61 (0.00%)
         occurrences all number
    2
    0
    Secretion discharge
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    0
    2
    Menstruation irregular
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 63 (1.59%)
    2 / 61 (3.28%)
         occurrences all number
    1
    3
    Bronchial obstruction
         subjects affected / exposed
    4 / 63 (6.35%)
    2 / 61 (3.28%)
         occurrences all number
    4
    2
    Bronchial secretion retention
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Bronchospasm
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    3
    0
    Cough
         subjects affected / exposed
    8 / 63 (12.70%)
    10 / 61 (16.39%)
         occurrences all number
    9
    12
    Dysphonia
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    10 / 63 (15.87%)
    3 / 61 (4.92%)
         occurrences all number
    12
    4
    Haemoptysis
         subjects affected / exposed
    5 / 63 (7.94%)
    8 / 61 (13.11%)
         occurrences all number
    5
    8
    Increased viscosity of bronchial secretion
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    0
    2
    Increased viscosity of nasal secretion
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Nasal mucosal disorder
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Nasal polyps
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    4 / 63 (6.35%)
    1 / 61 (1.64%)
         occurrences all number
    4
    1
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    2
    Rales
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 61 (1.64%)
         occurrences all number
    2
    1
    Sinus congestion
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 61 (1.64%)
         occurrences all number
    1
    1
    Sputum decreased
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 61 (1.64%)
         occurrences all number
    1
    1
    Sputum discoloured
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    0
    2
    Sputum increased
         subjects affected / exposed
    6 / 63 (9.52%)
    5 / 61 (8.20%)
         occurrences all number
    6
    5
    Sputum retention
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Wheezing
         subjects affected / exposed
    4 / 63 (6.35%)
    2 / 61 (3.28%)
         occurrences all number
    4
    2
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Sleep disorder
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Bacterial test positive
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Blood glucose increased
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Blood phosphorus increased
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Blood potassium increased
         subjects affected / exposed
    3 / 63 (4.76%)
    5 / 61 (8.20%)
         occurrences all number
    3
    5
    Blood uric acid increased
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 61 (1.64%)
         occurrences all number
    1
    1
    Body temperature increased
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    3 / 63 (4.76%)
    0 / 61 (0.00%)
         occurrences all number
    3
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Haemoglobin increased
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Liver function test abnormal
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Pulmonary function test decreased
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Red blood cell count increased
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Sputum abnormal
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 61 (1.64%)
         occurrences all number
    1
    1
    Sputum culture positive
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Urine leukocyte esterase
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    White blood cell count increased
         subjects affected / exposed
    4 / 63 (6.35%)
    1 / 61 (1.64%)
         occurrences all number
    4
    1
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Arthropod bite
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 61 (1.64%)
         occurrences all number
    1
    1
    Excoriation
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Animal bite
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    Cystic fibrosis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Sinus arrhythmia
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 61 (1.64%)
         occurrences all number
    1
    1
    Headache
         subjects affected / exposed
    2 / 63 (3.17%)
    7 / 61 (11.48%)
         occurrences all number
    2
    10
    Lethargy
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 61 (1.64%)
         occurrences all number
    2
    1
    Speech disorder
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Tremor
         subjects affected / exposed
    3 / 63 (4.76%)
    0 / 61 (0.00%)
         occurrences all number
    3
    0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Eye disorders
    Corneal opacity
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Dry eye
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 61 (1.64%)
         occurrences all number
    2
    1
    Abdominal pain
         subjects affected / exposed
    1 / 63 (1.59%)
    2 / 61 (3.28%)
         occurrences all number
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 61 (1.64%)
         occurrences all number
    2
    1
    Constipation
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 61 (1.64%)
         occurrences all number
    2
    1
    Diarrhoea
         subjects affected / exposed
    4 / 63 (6.35%)
    0 / 61 (0.00%)
         occurrences all number
    4
    0
    Flatulence
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    3 / 63 (4.76%)
    2 / 61 (3.28%)
         occurrences all number
    3
    2
    Vomiting
         subjects affected / exposed
    3 / 63 (4.76%)
    1 / 61 (1.64%)
         occurrences all number
    3
    2
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 61 (1.64%)
         occurrences all number
    2
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 63 (4.76%)
    2 / 61 (3.28%)
         occurrences all number
    3
    2
    Back pain
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 61 (1.64%)
         occurrences all number
    2
    1
    Flank pain
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Mobility decreased
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 61 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Polyarthritis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    3
    0
    Appendicitis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Bacterial infection
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Burkholderia gladioli infection
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    8 / 63 (12.70%)
    7 / 61 (11.48%)
         occurrences all number
    8
    7
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 61 (0.00%)
         occurrences all number
    2
    0
    Lower respiratory tract infection fungal
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    12 / 63 (19.05%)
    10 / 61 (16.39%)
         occurrences all number
    14
    11
    Otosalpingitis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    4 / 63 (6.35%)
    5 / 61 (8.20%)
         occurrences all number
    5
    5
    Sputum purulent
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    Hypoglycaemia
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 61 (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? Yes
    Date
    Amendment
    02 Mar 2015
    It is added in inclusion criterion # 5 that patients with Gamma Glutamyl Transferase (GGT) values ​​above 3 x ULN (upper limit of normal) can be included. In Exclusion Criterion # 14, which states that patients with blood values > 3 upper normal value should excluded, exceptions are made for exclusion if the GGT value is above 3x upper normal value. Specialists have confirmed that CF patients often have elevated Gamma Glutamyl Transferase (GGT), without changes in other liver function tests, such as ALT, AST, alkaline phosphatase and bilirubin. Studies have shown that interpretation of adverse events in clinical trials is complicated by the underlying high incidence of abnormal lab values ​​in CF patients. Excluding patients with normal abnormalities can lead to a selected CF population in the study, which is not desirable.
    29 Aug 2016
    Amendment 2: This amendment was implemented to allow for retrospective data collection from pre and post study patient visits. The data to be collected included information on FEV1, FVC, FEF25-75, pulmonary exacerbations, antibiotic treatment (i.v.) and hospitalisations. Pulmonary exacerbations are critical events in the disease progression of patients with Cystic Fibrosis, causing acute morbidity with implications for long term morbidity and mortality. For improvement of a pivotal phase III study design, this protocol amendment was implemented to collect further long-term data regarding potential pulmonary exacerbation and hospitalisation rates before and after OligoG treatment.

    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.
    The protocol aimed for recruitment of 76 patients. Due to low recruitment rate the study was stopped after recruitment of 65 patients.
    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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