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    Clinical Trial Results:
    A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in patients with Pseudomonas Aeruginosa (Atorvastatin 1)

    Summary
    EudraCT number
    2010-022042-24
    Trial protocol
    GB  
    Global end of trial date
    31 May 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Aug 2020
    First version publication date
    01 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Atorvastatin 1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01299194
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    ACCORD (University of Edinburgh & Lothian Healthboard)
    Sponsor organisation address
    47 Little France Crescent, Edinburgh, United Kingdom, EH16 4TJ
    Public contact
    Dr Pallavi Bedi, University of Edinburgh, +44 01312426662, drpallavibedi@gmail.com
    Scientific contact
    Prof Adam Hill, NHS Lothian, +44 01312421921, adam.hill318@nhs.net
    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
    10 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Dec 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this randomised, double-blind controlled cross over study is to evaluate the efficacy of a 3 months treatment with atorvastatin versus placebo in patients with clinically significant bronchiectasis with colonisation with Pseudomonas aeruginosa.
    Protection of trial subjects
    The study was conducted in accordance with all relevant data protection, ethical and regulatory requirements to ensure the privacy and security of patient information and to ensure the rights, safety and well-being of the patients and the quality of the research data.
    Background therapy
    Excluded patients on a statin therapy.
    Evidence for comparator
    -
    Actual start date of recruitment
    14 Mar 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
    United Kingdom: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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)
    13
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients were recruited from a meeting that they were invited to in the Royal Infirmary of Edinburgh, where information regarding the trial was provided.

    Pre-assignment
    Screening details
    44 patients were screened for eligibility according to the protocol inclusion and exclusion criteria. 12 patients were excluded pre-randomisation: not meeting inclusion criteria (n = 9); declined to participate (n = 3); other reasons (n = 0).

    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
    Blinding implementation details
    Unmatched placebo

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Atorvastatin
    Arm description
    Atorvastatin
    Arm type
    Experimental

    Investigational medicinal product name
    Atorvastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet daily at night

    Arm title
    Placebo
    Arm description
    Placebo
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet daily at night

    Number of subjects in period 1
    Atorvastatin Placebo
    Started
    16
    16
    Completed
    13
    14
    Not completed
    3
    2
         Discontinued intervention
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    Thirty-two patients chronically infected with P aeruginosa were recruited in this double-blind cross-over randomized controlled trial. Sixteen patients were recruited in each arm, were given atorvastatin 80 mg or placebo for 3 months followed by a washout period for 6 weeks, and then crossed over and administered the alternative therapy for 3 months.

    Reporting group values
    Overall trial Total
    Number of subjects
    32 32
    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)
    13 13
        From 65-84 years
    19 19
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    21 21
        Male
    11 11

    End points

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    End points reporting groups
    Reporting group title
    Atorvastatin
    Reporting group description
    Atorvastatin

    Reporting group title
    Placebo
    Reporting group description
    Placebo

    Primary: Cough severity

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    End point title
    Cough severity
    End point description
    Cough severity measured by Leicester Cough Questionnaire (LCQ). LCQ scores from 3 till 21, where a lower score means worse quality of life.
    End point type
    Primary
    End point timeframe
    At the end of study - 3 months.
    End point values
    Atorvastatin Placebo
    Number of subjects analysed
    16
    16
    Units: LCQ Score
    16
    16
    Statistical analysis title
    Primary Outcome
    Statistical analysis description
    We used a two-sided paired test with a 5% level of significance, 80% power, and a mean of difference of 1.3. The sample size was 26 subjects. To account for an approximate 20% dropout rate, we recruited 32 patients. We analyzed the study with a modified intention-to-treat model. We did not take the washout period into account. To compare the proportion of patients with either clinical improvement (measured by the LCQ) or quality of life gains (measured by the SGRQ), we used a McNemar test.
    Comparison groups
    Atorvastatin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    = 0.125 [2]
    Method
    t-test, 2-sided
    Confidence interval
    Notes
    [1] - We analyzed the study with a modified intention-to-treat model. For demographic and clinical variables, we presented data as mean (SD) for continuous variables and number (%) for categorical variables, unless otherwise stated. To examine continuous variables, we calculated the change during the atorvastatin period (either baseline-3 months or 4-7 months) and compared this to the change during the placebo period (either 4-7 months or baseline-3 months] by a paired t test.
    [2] - There was no evidence of a difference in the mean LCQ change in patients treated with atorvastatin compared with those treated with placebo (mean difference, 1.92; 95% CI, –0.57-4.41; P = .125).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Within one week of the incident.
    Adverse event reporting additional description
    Adverse events were reported to the sponsor on the sponsors SAE reporting form.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Atorvastatin
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    Atorvastatin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Atorvastatin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 16 (12.50%)
    General disorders and administration site conditions
    Transient ischaemic attack
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Mar 2011
    Protocol v3
    21 Oct 2011
    Protocol v4

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/29406231
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