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    Clinical Trial Results:
    An open, phase I study in male adolescents with asthma, aged 12 to 17 years, to assess pharmacokinetics of orally administered AZD1981 tablets 100 mg twice daily for 6½ days

    Summary
    EudraCT number
    2010-021520-10
    Trial protocol
    SE  
    Global end of trial date
    02 Feb 2011

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Feb 2017
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AZD1981
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Christopher D. O’Brien, 1800 Concord Pike, C4B-125, Wilmington, United States, DE 19850
    Public contact
    Christopher D. O’Brien, MD, PhD, FCCP, Medical Science Director, AstraZeneca, +1 302 886 3577,
    Scientific contact
    Professor Lennart Nordvall, MD, PhD, Barnmedicin, Akademiska sjukhuset, SE-751 85 Uppsala, Sweden, +46 70 312 44 20,
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Feb 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Feb 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Feb 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the pharmacokinetics (PK) of orally administered AZD1981 in male adolescents with asthma.
    Protection of trial subjects
    AstraZeneca’s quality assurance and quality control procedures provide reassurance that the clinical study programme was carried out in accordance with GCP guidelines. AstraZeneca undertakes a GCP audit programme to ensure compliance with its procedures and to assess the adequacy of its quality control measures. Audits, by a Global Quality Assurance group operating independently of the study monitors and in accordance with documented policies and procedures, are directed towards all aspects of the clinical study process and its associated documentation.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    14 Oct 2010
    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
    Sweden: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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)
    23
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Of the 23 enrolled patients, 22 started treatment with AZD1981. All 22 patients completed the study.

    Pre-assignment period milestones
    Number of subjects started
    23
    Number of subjects completed
    22

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Protocol deviation: 1
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    AZD1981 100 mg twice daily
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    AZD1981
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg twice daily

    Number of subjects in period 1 [1]
    AZD1981 100 mg twice daily
    Started
    22
    Completed
    22
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Patient has been excluded from the study due to not meeting one of the inclusion criteria.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZD1981 100 mg twice daily
    Reporting group description
    -

    Reporting group values
    AZD1981 100 mg twice daily Total
    Number of subjects
    22 22
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    22 22
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    14.3 (12 to 17) -
    Gender categorical
    Units: Subjects
        Female
    0 0
        Male
    22 22

    End points

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    End points reporting groups
    Reporting group title
    AZD1981 100 mg twice daily
    Reporting group description
    -

    Primary: AUC at steady state

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    End point title
    AUC at steady state [1]
    End point description
    Day 7, 30min, 1h, 3h, 4h, 6h, 8h and 12h efter last dose
    End point type
    Primary
    End point timeframe
    Day 7
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There is no analysis for this trial, just summary statistics. This is observational study.
    End point values
    AZD1981 100 mg twice daily
    Number of subjects analysed
    22
    Units: nmol*h/L
        geometric mean (geometric coefficient of variation)
    16248.4 ± 28.9
    No statistical analyses for this end point

    Primary: C-max at steady state

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    End point title
    C-max at steady state [2]
    End point description
    Day 7, 30min, 1h, 3h, 4h, 6h, 8h and 12h efter last dose
    End point type
    Primary
    End point timeframe
    Day 7
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There is no analysis for this trial, just summary statistics. This is observational study.
    End point values
    AZD1981 100 mg twice daily
    Number of subjects analysed
    22
    Units: nmol/L
        geometric mean (geometric coefficient of variation)
    4157.2 ± 38.3
    No statistical analyses for this end point

    Primary: C-trough at steady state

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    End point title
    C-trough at steady state [3]
    End point description
    Day 7, 30min, 1h, 3h, 4h, 6h, 8h and 12h efter last dose
    End point type
    Primary
    End point timeframe
    Day
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There is no analysis for this trial, just summary statistics. This is observational study.
    End point values
    AZD1981 100 mg twice daily
    Number of subjects analysed
    22
    Units: nmol/L
        geometric mean (geometric coefficient of variation)
    205.5 ± 56.9
    No statistical analyses for this end point

    Primary: CL/F

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    End point title
    CL/F [4]
    End point description
    Day 7, 30min, 1h, 3h, 4h, 6h, 8h and 12h efter last dose
    End point type
    Primary
    End point timeframe
    Day 7
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There is no analysis for this trial, just summary statistics. This is observational study.
    End point values
    AZD1981 100 mg twice daily
    Number of subjects analysed
    22
    Units: L/h
        geometric mean (geometric coefficient of variation)
    15.83 ± 28.9
    No statistical analyses for this end point

    Secondary: Ae at steady state

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    End point title
    Ae at steady state
    End point description
    Day 7, 30min, 1h, 3h, 4h, 6h, 8h and 12h efter last dose
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    AZD1981 100 mg twice daily
    Number of subjects analysed
    22
    Units: nmol
        geometric mean (geometric coefficient of variation)
    76645.3 ± 39.7
    No statistical analyses for this end point

    Secondary: Fe at steady state

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    End point title
    Fe at steady state
    End point description
    Day 7, 30min, 1h, 3h, 4h, 6h, 8h and 12h efter last dose
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    AZD1981 100 mg twice daily
    Number of subjects analysed
    22
    Units: NA
        geometric mean (geometric coefficient of variation)
    0.298 ± 39.7
    No statistical analyses for this end point

    Secondary: CLR

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    End point title
    CLR
    End point description
    Day 7, 30min, 1h, 3h, 4h, 6h, 8h and 12h efter last dose
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    AZD1981 100 mg twice daily
    Number of subjects analysed
    22
    Units: L/h
        geometric mean (geometric coefficient of variation)
    4.72 ± 45.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    one month
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    AZD1981
    Reporting group description
    100 mg, 1x 100 mg bid;oral administration

    Serious adverse events
    AZD1981
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    AZD1981
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 22 (36.36%)
    Investigations
    Thyroid function test abnormal
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Thyroid function test
    Additional description: Elevated TSH, Blood Thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Throat pain
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Asthmatic attack induced
    Additional description: Exercise induced
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Asthma NOS
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Nervous system disorders
    Syncope
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Infections and infestations
    Upper resp tract infection
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Nasopharyngeal disorder
    Additional description: Nasopharyngitis
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Oct 2010
    According to the CSP, 1 centre was to be used for the investigation; by the amendment this was changed to at least 1 centre.
    27 Oct 2010
    Instead of having the treatment period of AZD1981 restricted to exactly 6½ days, a time window of –1 day and +2 days was allowed. Still steady state
    27 Oct 2010
    Visit 2 (the later of 2 screening occasions) was to take place within 21 days of Visit 3 (start of treatment). In previous text (CSP), it was not clear to which screening visit that the 21-day frame was related. Visit 1 and Visit 2 can occur at the same occasion.
    27 Oct 2010
    Instead of having a fix limit (4 weeks) ahead of Visit 3 with regards to nonallowed medication during treatment, the amendment states 2 weeks or 5 times the half-life, whichever was the longest.
    27 Oct 2010
    Allowed medication during treatment was changed from solely inhaled asthma medication to include medications for treatment of e.g. rhinitis and eczema. The pharmacokinetic evaluation of AZD1981 was considered to be unaffected by this change.

    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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