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    Clinical Trial Results:
    A randomised placebo-controlled pilot trial of omeprazole in idiopathic pulmonary fibrosis (IPF)

    Summary
    EudraCT number
    2013-003301-26
    Trial protocol
    GB  
    Global end of trial date
    27 Sep 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Jan 2019
    First version publication date
    05 Jan 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IAFIPF001
    Additional study identifiers
    ISRCTN number
    ISRCTN07139948
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    REC reference: 13/YH/0284
    Sponsors
    Sponsor organisation name
    The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Sponsor organisation address
    Joint Research Office, Level 1 Regent Point, Regent Farm Road, Gosforth, Newcastle upon Tyne, United Kingdom, NE3 3HD
    Public contact
    Professor John Simpson, Newcastle University, 0191 2087770, j.simpson@newcastle.ac.uk
    Scientific contact
    Professor John Simpson, Newcastle University, 0191 2087770, j.simpson@newcastle.ac.uk
    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
    01 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal question is whether omeprazole reduces cough (quantified objectively) in patients with IPF, when compared with placebo.
    Protection of trial subjects
    Omeprazole is a substituted benzimidazole, and belongs to the “proton pump inhibitor” (PPI) class of drugs. Omeprazole specifically inhibits the hydrogen-potassium-ATPase (H/K-ATPase) enzyme at the apical surface of gastric parietal cells. H/K-ATPase is responsible for delivering hydrogen ions to the lumen of the stomach, thus acidifying the contents. Omeprazole’s dose-dependent and specific inhibition of the enzyme therefore neutralizes gastric acid contents. Omeprazole inhibits basal and induced gastric acid release. Omeprazole has been used clinically for many years. It is licensed for use in gastro-oesophageal reflux, erosive oesophagitis, duodenal ulcer, gastric ulcer, eradication of Helicobacter pylori (in combination with antibiotics), and Zollinger-Ellison syndrome. It is also used for the prevention of gastric adverse events associated with use of non-steroidal anti-inflammatory drugs. Patients will be advised by their doctor to report any unusual symptoms or reactions. Patients will be provided with a contact number on which they may contact a member of the study team to obtain advice and express any concerns, throughout the duration of the study. This information will be included in the patient information leaflet.
    Background therapy
    Potential participants in the trial were asked to consent to a trial off PPI, if there was no return of symptoms, they were consented onto the full trial. If there was any return of symptoms and the trial off PPI was not tolerated, the patient went back onto their normal standard care.
    Evidence for comparator
    N/A
    Actual start date of recruitment
    01 Mar 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
    United Kingdom: 45
    Worldwide total number of subjects
    45
    EEA total number of subjects
    45
    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)
    5
    From 65 to 84 years
    38
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were identified by qualified research staff from current lists of potential patients attending local clinics, or identified and referred for participant in the trial from Participant Identification Centres (PICs) by their treating clinicians.

    Pre-assignment
    Screening details
    If the potential participant was currently taking antacids, prokinetics or raft alginates at the time of screening, they were eligible if they have been off these treatments for a period of two weeks. Participants consented to a trial off these treatments. If there was no return of symptoms, they could go onto the trial.

    Pre-assignment period milestones
    Number of subjects started
    54 [1]
    Number of subjects completed
    45

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Return of Symptoms: 9
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: If patients taking omeprazole (or a related stomach treatment) wished to take part, patient consented to a trial period off treatment for 2 weeks. If symptoms returned during that 2- week period the patient went back on treatment and did not take part in the study. If patients managed well without the treatment for 2 weeks, they were asked to sign a second consent form before starting the trial.
    Period 1
    Period 1 title
    Visit 1
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Participants were randomised at period 3.

    Arms
    Arm title
    Assessment
    Arm description
    Assessment and medical tests
    Arm type
    pre-randomisation

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    Assessment
    Started
    45
    Completed
    45
    Period 2
    Period 2 title
    Visit 2
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Randomisation took place at period 3.

    Arms
    Arm title
    Assessment
    Arm description
    Assessment and medical tests
    Arm type
    pre-randomisation

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    Assessment
    Started
    45
    Completed
    45
    Period 3
    Period 3 title
    Visit 3
    Is this the baseline period?
    Yes [2]
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    Randomisation was conducted by the Newcastle Clinical Trials Unit (NCTU) secure password-protected web based system. Patients were randomised on a 1:1 ratio to either Omeprazole 20mg twice daily or Placebo twice daily. No unblinding was required during the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Omeprazole
    Arm description
    Omeprazole
    Arm type
    Experimental

    Investigational medicinal product name
    Omeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg twice daily

    Arm title
    Placebo
    Arm description
    Placebo
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule, twice daily

    Notes
    [2] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: During period 1 and period 2 participants underwent tests and assessment, they were not randomised until period 3.
    Number of subjects in period 3
    Omeprazole Placebo
    Started
    23
    22
    Completed
    23
    22
    Period 4
    Period 4 title
    up to 90 days on Trial IMP
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    Randomisation was conducted by the Newcastle Clinical Trials Unit (NCTU) secure password-protected web based system. Patients were randomised on a 1:1 ratio to either Omeprazole 20mg twice daily or Placebo twice daily. No unblinding was required during the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Omeprazole
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Omeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg twice daily

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule, twice daily

    Number of subjects in period 4
    Omeprazole Placebo
    Started
    23
    22
    Completed
    20
    20
    Not completed
    3
    2
         Physician decision
    2
    1
         Adverse event, serious fatal
    1
    -
         Participant withdrew due to non serious AE
    -
    1
    Period 5
    Period 5 title
    Visit 4
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    Randomisation was conducted by the Newcastle Clinical Trials Unit (NCTU) secure password-protected web based system. Patients were randomised on a 1:1 ratio to either Omeprazole 20mg twice daily or Placebo twice daily. No unblinding was required during the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Omeprazole
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Omeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg twice daily

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule, twice daily

    Number of subjects in period 5
    Omeprazole Placebo
    Started
    20
    20
    Completed
    20
    20
    Period 6
    Period 6 title
    Visit 5
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    Randomisation was conducted by the Newcastle Clinical Trials Unit (NCTU) secure password-protected web based system. Patients were randomised on a 1:1 ratio to either Omeprazole 20mg twice daily or Placebo twice daily. No unblinding was required during the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Omeprazole
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Omeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg twice daily

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule, twice daily

    Number of subjects in period 6
    Omeprazole Placebo
    Started
    20
    20
    Completed
    20
    20
    Period 7
    Period 7 title
    Visit 6
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    Randomisation was conducted by the Newcastle Clinical Trials Unit (NCTU) secure password-protected web based system. Patients were randomised on a 1:1 ratio to either Omeprazole 20mg twice daily or Placebo twice daily. No unblinding was required during the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Omeprazole
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Omeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg twice daily

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule, twice daily

    Number of subjects in period 7
    Omeprazole Placebo
    Started
    20
    20
    Completed
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Omeprazole
    Reporting group description
    Omeprazole

    Reporting group title
    Placebo
    Reporting group description
    Placebo

    Reporting group values
    Omeprazole Placebo Total
    Number of subjects
    23 22 45
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    2 3 5
        From 65-84 years
    20 18 38
        85 years and over
    1 1 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    71.3 ± 6.7 71 ± 7.3 -
    Gender categorical
    Units: Subjects
        Female
    4 6 10
        Male
    19 16 35
    Ethnicity
    Units: Subjects
        Caucasian
    23 22 45
    Smoking History
    Units: Subjects
        Never Smoked
    5 5 10
        Ex-Smoker
    18 16 34
        Current Smoker
    0 1 1
    Kco
    Units: Subjects
        Done
    23 21 44
        Not done
    0 1 1
    Tlco
    Units: Subjects
        Done
    23 21 44
        Not done
    0 1 1
    6 minute walk test
    Units: Subjects
        Done
    23 21 44
        Not done
    0 1 1
    Number of Pack Years
    Units: Pack Years
        median (full range (min-max))
    13 (0 to 74) 15 (2 to 60) -
    Number of co-morbidities
    Units: Number
        arithmetic mean (standard deviation)
    3.6 ± 1.6 3.2 ± 1.5 -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    28.9 ± 3.8 29.6 ± 6 -
    Blood Pressure diastolic
    Units: mmHg
        arithmetic mean (standard deviation)
    71 ± 13.4 72.7 ± 9.3 -
    Blood pressure systolic
    Units: mmHg
        arithmetic mean (standard deviation)
    120.5 ± 14.7 126.2 ± 14.1 -
    Heart Rate
    Units: beats per minute
        arithmetic mean (standard deviation)
    71.4 ± 13.4 80.9 ± 12.7 -
    Respiratory rate
    Units: per minute
        arithmetic mean (standard deviation)
    21.5 ± 3.5 22.4 ± 3.8 -
    FEV1
    Units: Litres
        arithmetic mean (standard deviation)
    2.06 ± 0.51 2.01 ± 0.6 -
    FEV1 (% Predicted)
    Units: Percentage
        arithmetic mean (standard deviation)
    76.91 ± 15.42 78.45 ± 18.44 -
    FVC
    Units: Litres
        arithmetic mean (standard deviation)
    2.53 ± 0.68 2.54 ± 0.76 -
    FVC (% Predicted)
    Units: Percentage
        arithmetic mean (standard deviation)
    73.13 ± 17.12 77.95 ± 17.62 -
    FEV1/FVC
    Units: Percentage
        arithmetic mean (standard deviation)
    82 ± 5 80 ± 13 -
    Kco
    Units: mmol/min/Kpa/litre
        arithmetic mean (standard deviation)
    1.13 ± 0.28 1.08 ± 0.26 -
    Kco (% predicted)
    Units: percentage
        arithmetic mean (standard deviation)
    87.3 ± 20.94 83 ± 22.04 -
    Tlco
    Units: mmol/minute/Kpa
        arithmetic mean (standard deviation)
    4.11 ± 1.57 3.86 ± 1.35 -
    Tlco (% Predicted
    Units: Percentage
        arithmetic mean (standard deviation)
    49.52 ± 15.73 48.43 ± 15.97 -
    6 minute walk test
    Units: Metres
        median (full range (min-max))
    416.5 (150 to 550) 372.5 (50 to 525) -
    DeMeester Reflux Associated Symptom Questionnaire
    Units: Score
        arithmetic mean (standard deviation)
    0.87 ± 0.81 1.45 ± 1.37 -
    Gastrointestinal Quality of Life Index
    Units: Score
        arithmetic mean (standard deviation)
    106.3 ± 17.9 104.77 ± 17.79 -
    Leicester Cough Questionnaire
    Units: Score
        arithmetic mean (standard deviation)
    15.06 ± 3.23 15.38 ± 3.2 -
    Leicester Cough Questionnaire - Physical
    Units: Score
        arithmetic mean (standard deviation)
    5.04 ± 1.04 5.23 ± 0.99 -
    Leicester Cough Questionnaire - Psychological
    Units: score
        arithmetic mean (standard deviation)
    4.9 ± 1.33 4.96 ± 1.25 -
    Leicester Cough Questionnaire - Social
    Units: Score
        arithmetic mean (standard deviation)
    5.12 ± 1.06 5.19 ± 1.29 -
    Reflux Symptom Index Questionnaire
    Units: Score
        arithmetic mean (standard deviation)
    14.3 ± 9.55 17.14 ± 9.02 -
    Cough frequency
    Units: Coughs/Hour
        median (inter-quartile range (Q1-Q3))
    9.63 (4.12 to 18.29) 8.85 (6.76 to 12.79) -
    Daytime cough frequency
    Units: Coughs/hour
        median (inter-quartile range (Q1-Q3))
    13.38 (6.05 to 24.26) 11.59 (8.51 to 17.41) -
    Nightime cough frequency
    Units: Coughs/hour
        median (inter-quartile range (Q1-Q3))
    2.14 (0.52 to 6.89) 2.6 (0.8 to 9.02) -
    Concomitant Medications
    Units: Number
        arithmetic mean (standard deviation)
    7.1 ± 3.7 7.4 ± 2.8 -

    End points

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    End points reporting groups
    Reporting group title
    Assessment
    Reporting group description
    Assessment and medical tests
    Reporting group title
    Assessment
    Reporting group description
    Assessment and medical tests
    Reporting group title
    Omeprazole
    Reporting group description
    Omeprazole

    Reporting group title
    Placebo
    Reporting group description
    Placebo
    Reporting group title
    Omeprazole
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -
    Reporting group title
    Omeprazole
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -
    Reporting group title
    Omeprazole
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -
    Reporting group title
    Omeprazole
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Primary: Change in 24 Cough Frequency

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    End point title
    Change in 24 Cough Frequency
    End point description
    End point type
    Primary
    End point timeframe
    Cough monitors returned at study visit 2 and study visit 5
    End point values
    Omeprazole Placebo
    Number of subjects analysed
    20
    20
    Units: coughs/hour
        median (full range (min-max))
    -1 (-19 to 4.4)
    0.8 (-27.25 to 38.58)
    Statistical analysis title
    Change in cough frequency
    Comparison groups
    Omeprazole v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    ANCOVA
    Parameter type
    Omeprazole:Placebo (final values)
    Point estimate
    0.61
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.34
         upper limit
    1.09

    Secondary: Change in DeMeester Reflux Associated Symptom Questionnaire score

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    End point title
    Change in DeMeester Reflux Associated Symptom Questionnaire score
    End point description
    End point type
    Secondary
    End point timeframe
    Questionnaires completed at Visit 1 and Visit 4
    End point values
    Omeprazole Placebo
    Number of subjects analysed
    20
    20
    Units: Score
        median (full range (min-max))
    0 (-2 to 3)
    0 (-2 to 2)
    No statistical analyses for this end point

    Secondary: Change in Gastrointestinal quality of life index score

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    End point title
    Change in Gastrointestinal quality of life index score
    End point description
    End point type
    Secondary
    End point timeframe
    Questionnaires completed at visit 1 and visit 4
    End point values
    Omeprazole Placebo
    Number of subjects analysed
    20
    20
    Units: Score
        median (full range (min-max))
    4.5 (-33 to 25)
    -0.5 (-32 to 22)
    Statistical analysis title
    Change in GIQIL score
    Comparison groups
    Omeprazole v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    2.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.2
         upper limit
    11.49
    Notes
    [1] - Descriptive

    Secondary: Change in Leicester Cough Questionnaire Score

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    End point title
    Change in Leicester Cough Questionnaire Score
    End point description
    End point type
    Secondary
    End point timeframe
    Questionnaires completed at visit 1 and visit 4
    End point values
    Omeprazole Placebo
    Number of subjects analysed
    20
    20
    Units: Score
        median (full range (min-max))
    -0.29 (-5.61 to 5.34)
    -0.9 (-7.27 to 9.32)
    Statistical analysis title
    Change in LCQ score
    Comparison groups
    Omeprazole v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    other [2]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.19
         upper limit
    1.98
    Notes
    [2] - Descriptive

    Secondary: Change in Reflux Symptom Index Score

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    End point title
    Change in Reflux Symptom Index Score
    End point description
    End point type
    Secondary
    End point timeframe
    Questionnaires completed at visit 1 and visit 4
    End point values
    Omeprazole Placebo
    Number of subjects analysed
    20
    20
    Units: Score
        median (full range (min-max))
    0 (-11 to 21)
    1 (-25 to 14)
    Statistical analysis title
    Change in RSI score
    Comparison groups
    Omeprazole v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    other [3]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.67
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.77
         upper limit
    6.11
    Notes
    [3] - Descriptive

    Secondary: Change in Six Minute Walk Test distance

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    End point title
    Change in Six Minute Walk Test distance
    End point description
    End point type
    Secondary
    End point timeframe
    6MWT completed at visit 1 and visit 4
    End point values
    Omeprazole Placebo
    Number of subjects analysed
    19
    19
    Units: Metres
        median (full range (min-max))
    -10 (-225 to 62.6)
    0 (-73.1 to 102)
    Statistical analysis title
    Change in 6MWT distance
    Comparison groups
    Omeprazole v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    other [4]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -30.36
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -68.86
         upper limit
    8.13
    Notes
    [4] - Descriptive

    Secondary: Change in percentage predicted FVC

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    End point title
    Change in percentage predicted FVC
    End point description
    End point type
    Secondary
    End point timeframe
    Lung function tests performed at visit 1 and visit 4
    End point values
    Omeprazole Placebo
    Number of subjects analysed
    19
    20
    Units: % Predicted
        median (full range (min-max))
    -2 (-27 to 5)
    0.5 (-4 to 14)
    Statistical analysis title
    Change in % Predicted FVC
    Comparison groups
    Omeprazole v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    other [5]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -5.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.39
         upper limit
    -0.8
    Notes
    [5] - Descriptive

    Secondary: Change in precentage predicted TLCO

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    End point title
    Change in precentage predicted TLCO
    End point description
    End point type
    Secondary
    End point timeframe
    Lung function tests performed at visit 1 and visit 4
    End point values
    Omeprazole Placebo
    Number of subjects analysed
    18
    18
    Units: % Predicted
        median (full range (min-max))
    -2 (-14 to 17)
    -5.5 (-12 to 16)
    Statistical analysis title
    Change in % predicted TLCO
    Comparison groups
    Omeprazole v Placebo
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    other [6]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    2.46
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.06
         upper limit
    7.98
    Notes
    [6] - Descriptive

    Secondary: Change in percentage predicted FEV1

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    End point title
    Change in percentage predicted FEV1
    End point description
    End point type
    Secondary
    End point timeframe
    Lung function tests performed at visit 1 and visit 4
    End point values
    Omeprazole Placebo
    Number of subjects analysed
    19
    20
    Units: % Predicted
        median (full range (min-max))
    -1 (-19 to 7)
    2 (-3 to 63)
    Statistical analysis title
    Change in % predicted FEV1
    Comparison groups
    Omeprazole v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    other [7]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -7.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.59
         upper limit
    -0.2
    Notes
    [7] - Descriptive

    Secondary: Change in percentage predicted KCO

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    End point title
    Change in percentage predicted KCO
    End point description
    End point type
    Secondary
    End point timeframe
    Lung function tests performed at visit 1 and visit 4
    End point values
    Omeprazole Placebo
    Number of subjects analysed
    18
    18
    Units: % Predicted
        median (full range (min-max))
    4 (-22 to 42)
    -8.5 (-17 to 24)
    Statistical analysis title
    Change in % predicted KCO
    Comparison groups
    Omeprazole v Placebo
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    other [8]
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    9.26
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.94
         upper limit
    17.58
    Notes
    [8] - Descriptive

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the baseline visit, through to visit 6.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    As reported
    Dictionary version
    1.0
    Reporting groups
    Reporting group title
    Omeprazole
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    Omeprazole Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 23 (17.39%)
    4 / 22 (18.18%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Ischemia
    Additional description: Hospital Admission – Right Ischaemic Leg
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung Neoplasm malignant
    Additional description: New diagnosis – lung cancer.
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
    Additional description: Hospital Admission cellulitis with possible chest infection
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
    Additional description: Hospital admission with Sepsis, likely related to skin
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 22 (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: 0%
    Non-serious adverse events
    Omeprazole Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 23 (52.17%)
    13 / 22 (59.09%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Back Injury
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 23 (13.04%)
    1 / 22 (4.55%)
         occurrences all number
    3
    1
    Cough Syncope
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    5
    Oropharyngeal pain
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    sore throat
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    Headache
         subjects affected / exposed
    0 / 23 (0.00%)
    4 / 22 (18.18%)
         occurrences all number
    0
    5
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    Local swelling
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Oedema
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 22 (4.55%)
         occurrences all number
    2
    1
    Acid reflux
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    4
    Diarrhoea
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 22 (9.09%)
         occurrences all number
    1
    5
    Dyspepsia
         subjects affected / exposed
    1 / 23 (4.35%)
    3 / 22 (13.64%)
         occurrences all number
    1
    9
    Gastric ulcer
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Salivary gland calculus
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 23 (8.70%)
    4 / 22 (18.18%)
         occurrences all number
    3
    10
    Constipation
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    Lower respiratory tract infection
         subjects affected / exposed
    5 / 23 (21.74%)
    2 / 22 (9.09%)
         occurrences all number
    5
    2
    Urinary tract infection
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jan 2014
    Substantial Amendment 3 (Substantial Amendments 1 and 2 were submitted prior to MHRA and REC approval for the trial). The following documents were updated: Protocol updated to v3.0 20/11/2013 Study documents updated: GP/Information sheets v1.1 20/11/2013, Informed Consent Form v1.1, 20/11/2013, Patient Diary Card v1.0 06/12/2013, Patient Information Sheet v1.1 20/11/2013, Participant Consent Form: Discontinuation of medication v1.1 20/11/2013. This amendment was to clarify certain sections in the protocol in greater detail, such as: patient recruitment, statistical analysis, pharmacovigilance, reporting of adverse events during the study period. This amendment was given favourable REC opinion on: 10/01/2014 This was granted MHRA approval on: 15/01/2014 This amendment was to clarify certain sections in the protocol in greater detail, such as: patient recruitment, statistical analysis, pharmacovigilance, reporting of adverse events during the study period. This was submitted to REC on: 16/12/2013 and granted approval on: 10/01/2014 This was submitted to the MHRA on: 16/12/2013 and granted approval on: 15/01/2014
    02 Sep 2014
    Substantial Amendment 4 The following documents were updated: Participant consent form 2.0 03/07/2014, Participant consent form: discontinuation of medication v2.0 03/07/2014, Participant Information Sheet v2.0 03/07/2014. Production specification 2013-5 Revision B This amendment was to update documents in line with the Data Monitoring Committee recommendations. This amendment was given favourable REC opinion on: 26/08/2014 This was granted MHRA approval on: 02/09/2014
    18 Aug 2016
    Substantial Amendment 5 The following documents were updated: Participant consent form v3.1 05/08/2016, Participant consent form v3.1 05/08/2016, Participant Information Sheet v3.1 07/03/2016. SmPC v07 15/12/2015. This amendment was to update the Reference Safety Information for the trial, update the study end date and update documents in line with staff changes on the Trial. The details regarding the randomisation system and study unblinding information were updated as part of this amendment. A number of minor clerical errors were corrected and the Sponsor contact name in IRAS has been changed in line with staff changes. Sections 7.3, 3.5 and 5.3 of the protocol were updated to give greater clarity and new information. The PIS was updated in line with withdrawal information and Nintedanib was added as active trial of treatment in exclusion criteria. This amendment was given favourable REC opinion on: 26/08/2014 This was granted MHRA approval on: 18/08/2016

    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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