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    Clinical Trial Results:
    Acetylic salicylic acid for the treatment of Chronic Obstructive Pulmonary Disease (COPD). A randomized, double-blind, placebo-controlled trial

    Summary
    EudraCT number
    		 2010-022123-29
    Trial protocol
    		 AT  
    Global end of trial date
    25 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Jul 2019
    First version publication date
    27 Jul 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ASA-COPD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währinger Gürtel 18-20, Vienna, Austria, 1090
    Public contact
    Markus Zeitlinger, Md, Medical University of Vienna, Department of Clinical Pharmacology, 0043 14040029810, markus.zeitlinger@meduniwien.ac.at
    Scientific contact
    Markus Zeitlinger, Md, Medical University of Vienna, Department of Clinical Pharmacology, 0043 14040029810, markus.zeitlinger@meduniwien.ac.at
    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
    25 Feb 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Feb 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effect of ASA as add-on therapy in COPD patients in comparison to placebo in spirometric and clinical regard, and to evaluate safety of this therapy.
    Protection of trial subjects
    Subjects were under the supervision of a physician or an experienced nurse during the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jun 2011
    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
    Austria: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    22
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from the Dep. of Pulmology, Medical University Vienna

    Pre-assignment
    Screening details
    		 Check of the in- and Exclusion criteria, Physical examination, Vital signs and Laboratory assessment

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Study drug
    Arm description
    		 Subjects will be randomized (1:1) to receive the study drug (ASA)
    Arm type
    		 Experimental

    Investigational medicinal product name
    ASS Genericon 500 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ASS Genericon 500 mg, once daily for 12 weeks

    Arm title
    		 Matching Placebo
    Arm description
    		 Subjects will be randomized (1:1) to receive a placebo administered QD orally for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets without active substance (Fagron Barsbüttel, Germany) once daily for 12 weeks

    Number of subjects in period 1
    		Study drug Matching Placebo
    Started
    20
    20
    Completed
    19
    20
    Not completed
    1
    0
         Physician decision
    1
    -

    Baseline characteristics

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

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 40 40
    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)
    		 22 22
        From 65-84 years
    		 18 18
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 24 24

    End points

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    End points reporting groups
    Reporting group title
    Study drug
    Reporting group description
    		 Subjects will be randomized (1:1) to receive the study drug (ASA)

    Reporting group title
    Matching Placebo
    Reporting group description
    		 Subjects will be randomized (1:1) to receive a placebo administered QD orally for 12 weeks.

    Primary: Change in FEV1 after 12 weeks compared to baseline

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    End point title
    		 Change in FEV1 after 12 weeks compared to baseline
    End point description
    End point type
    Primary
    End point timeframe
    8 hours
    End point values
    		 Study drug Matching Placebo
    Number of subjects analysed
    19
    20
    Units: Bq/ml
        number (not applicable)
    19
    20
    Statistical analysis title
    		 Endpoint analysis
    Comparison groups
    Study drug v Matching Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from 06.Jun.2011 to 22.Dec.2013
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 40 (67.50%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 40 (17.50%)
         occurrences all number
    11
    Dizziness
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    4
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 40 (20.00%)
         occurrences all number
    9
    Bronchitis
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Chronic obstructive pulmonary disease
    Additional description: Exacerbation of the underlying disease
         subjects affected / exposed
    25 / 40 (62.50%)
         occurrences all number
    25
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Pharyngitis
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    25 Feb 2014
    The Interim Analysis has shown sufficient data for premature Termination of the clinical Trial.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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