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41741

Beschreibung

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

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  1. 09.01.21 09.01.21 -
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GlaxoSmithKline

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9. Januar 2021

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    Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)

    Englisch

    Screening - 12 Lead ECG; 12-Lead ECG Abnormalities; Pulmonary Function Tests; Inhaler Device Training

    1 Formulare  
    Administrative
    Beschreibung

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beschreibung

    Subject Identifier

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    12-Lead ECG
    Beschreibung

    12-Lead ECG

    Alias
    UMLS CUI-1
    C0430456
    Start date of ECG
    Beschreibung

    Start date of ECG

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0808070
    Planned Relative Time (ECG)
    Beschreibung

    Planned Relative Time (ECG)

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0439564
    Start Time of ECG
    Beschreibung

    Start Time of ECG

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1301880
    Ventricular Rate
    Beschreibung

    Ventricular Rate

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C2189285
    beats/min
    PR Interval
    Beschreibung

    PR Interval

    Datentyp

    integer

    Maßeinheiten
    • ms
    Alias
    UMLS CUI [1]
    C0429087
    ms
    QRS Duration
    Beschreibung

    QRS Duration

    Datentyp

    integer

    Maßeinheiten
    • ms
    Alias
    UMLS CUI [1]
    C0429025
    ms
    Uncorrected QT Interval
    Beschreibung

    Uncorrected QT Interval

    Datentyp

    integer

    Maßeinheiten
    • ms
    Alias
    UMLS CUI [1]
    C1287082
    ms
    QTc Interval
    Beschreibung

    QTc Interval

    Datentyp

    integer

    Maßeinheiten
    • ms
    Alias
    UMLS CUI [1]
    C0489625
    ms
    Result of the ECG
    Beschreibung

    Result of the ECG

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0438154
    12-Lead ECG Abnormalities
    Beschreibung

    12-Lead ECG Abnormalities

    Alias
    UMLS CUI-1
    C0430456
    UMLS CUI-2
    C1704258
    Date of ECG
    Beschreibung

    Date of ECG

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826640
    Time of ECG
    Beschreibung

    Time of ECG

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    12-Lead ECG Abnormalities
    Beschreibung

    12-Lead ECG Abnormalities

    Alias
    UMLS CUI-1
    C0430456
    UMLS CUI-2
    C1704258
    A. Rhythm
    Beschreibung

    A. Rhythm

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0232187
    Other abnormal rhythm - Comment
    Beschreibung

    Other abnormal rhythm - Comment

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0232187
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0947611
    B. P-Wave and QRS Morphology
    Beschreibung

    B. P-Wave and QRS Morphology

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2216025
    UMLS CUI [2]
    C0429098
    Other P-Wave and QRS Morphology - Comment
    Beschreibung

    Other P-Wave and QRS Morphology - Comment

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2216025
    UMLS CUI [2]
    C0429098
    UMLS CUI [3]
    C0205394
    UMLS CUI [4]
    C0947611
    C. Conduction
    Beschreibung

    C. Conduction

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0232217
    Other Conduction - Comment
    Beschreibung

    Other Conduction - Comment

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0232217
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0947611
    D. Myocaridal Infarction
    Beschreibung

    D. Myocaridal Infarction

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0027051
    Other Myocardial Infarction - Comment
    Beschreibung

    Other Myocardial Infarction - Comment

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0027051
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0947611
    E. Depolarisation/ Repolarisation (QRS-T)
    Beschreibung

    E. Depolarisation/ Repolarisation (QRS-T)

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1395184
    UMLS CUI [1,2]
    C0948857
    Other Depolarisation/ Repolarisation (QRS-T) - Comment
    Beschreibung

    Other Depolarisation/ Repolarisation (QRS-T) - Comment

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1395184
    UMLS CUI [1,2]
    C0948857
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [2]
    C0947611
    Other abnormalities
    Beschreibung

    Other abnormalities

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C0205394
    Other abnormalities - Comment
    Beschreibung

    Other abnormalities - Comment

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0947611
    Pulmonary Function Tests
    Beschreibung

    Pulmonary Function Tests

    Alias
    UMLS CUI-1
    C0024119
    Date (Pulmonary Function Tests)
    Beschreibung

    Date (Pulmonary Function Tests)

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0011008
    Pulmonary Function Test
    Beschreibung

    Pulmonary Function Test

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0024119
    Planned Relative Time (Pulmonary Function Tests)
    Beschreibung

    Planned Relative Time (Pulmonary Function Tests)

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0439564
    Actual Time of First Reading (Pulmonary Function Tests)
    Beschreibung

    Actual Time of First Reading (Pulmonary Function Tests)

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0040223
    Reading 1 (Pulmonary Function Tests)
    Beschreibung

    Reading 1 (Pulmonary Function Tests)

    Datentyp

    float

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0243095
    L
    Reading 2 (Pulmonary Function Tests)
    Beschreibung

    Reading 2 (Pulmonary Function Tests)

    Datentyp

    float

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0243095
    L
    Reading 3 (Pulmonary Function Tests)
    Beschreibung

    Reading 3 (Pulmonary Function Tests)

    Datentyp

    float

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0243095
    L
    Highest Reading (Pulmonary Function Tests) - A
    Beschreibung

    Highest Reading (Pulmonary Function Tests) - A

    Datentyp

    float

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0243095
    UMLS CUI [1,3]
    C1522410
    L
    Predicted Normal (Pulmonary Function Tests) - B
    Beschreibung

    Predicted Normal (Pulmonary Function Tests) - B

    Datentyp

    float

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0205307
    % Predicted Normal (Pulmonary Function Tests) - A/Bx100
    Beschreibung

    % Predicted Normal (Pulmonary Function Tests) - A/Bx100

    Datentyp

    float

    Alias
    UMLS CUI [1,1]
    C0024119
    UMLS CUI [1,2]
    C0205307
    UMLS CUI [2]
    C0439165
    Inhaler Device Training
    Beschreibung

    Inhaler Device Training

    Alias
    UMLS CUI-1
    C0021461
    UMLS CUI-2
    C0220931
    Has the subject received training on how to use the Diskus?
    Beschreibung

    Has the subject received training on how to use the Diskus?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021461
    UMLS CUI [1,2]
    C0220931
    Is the subject able to use the Diskus correctly?
    Beschreibung

    Is the subject able to use the Diskus correctly?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2349182
    UMLS CUI [1,2]
    C1524063
    UMLS CUI [1,3]
    C0021461
    UMLS CUI [1,4]
    C1553480
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Screening - 12 Lead ECG; 12-Lead ECG Abnormalities; Pulmonary Function Tests; Inhaler Device Training

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    12-Lead ECG
    C0430456 (UMLS CUI-1)
    Start date of ECG
    Item
    Start date of ECG
    date
    C0430456 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item
    Planned Relative Time (ECG)
    integer
    C0430456 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    Planned Relative Time (ECG)
    Code List
    Planned Relative Time (ECG)
    CL Item
    Screening (1)
    Start Time of ECG
    Item
    Start Time of ECG
    time
    C0430456 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Ventricular Rate
    Item
    Ventricular Rate
    integer
    C2189285 (UMLS CUI [1])
    PR Interval
    Item
    PR Interval
    integer
    C0429087 (UMLS CUI [1])
    QRS Duration
    Item
    QRS Duration
    integer
    C0429025 (UMLS CUI [1])
    Uncorrected QT Interval
    Item
    Uncorrected QT Interval
    integer
    C1287082 (UMLS CUI [1])
    QTc Interval
    Item
    QTc Interval
    integer
    C0489625 (UMLS CUI [1])
    Item
    Result of the ECG
    integer
    C0438154 (UMLS CUI [1])
    Result of the ECG
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant (2)
    CL Item
    Abnormal - clinically significant (3)
    CL Item
    No result (not available) (4)
    Item Group
    12-Lead ECG Abnormalities
    C0430456 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    Date of ECG
    Item
    Date of ECG
    date
    C2826640 (UMLS CUI [1])
    Time of ECG
    Item
    Time of ECG
    time
    C0040223 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    Item Group
    12-Lead ECG Abnormalities
    C0430456 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    Item
    A. Rhythm
    text
    C0232187 (UMLS CUI [1])
    A. Rhythm
    Code List
    A. Rhythm
    CL Item
    Sinus bradycardia (A1)
    CL Item
    Sinus bradycardia (heart rate 40 - 50 beats/min) (A21)
    CL Item
    Sinus bradycardia (heart rate 30 - 39 beats/min) (A22)
    CL Item
    Sinus bradycardia (heart rate <30 beats/min) (A23)
    CL Item
    Sinus pause (A3)
    CL Item
    Sinus tachycardia (heart rate >100 beats/min) (A2)
    CL Item
    Ectopic supraventricular beats (A4)
    CL Item
    Ectopic supraventricular rhythm (A20)
    CL Item
    Wandering atrial pacemaker (A17)
    CL Item
    Multifocal tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (A26)
    CL Item
    Supraventricular tachycardia (heart rate >100 beats/min) (A6)
    CL Item
    Atrial flutter (A7)
    CL Item
    Atrial fibrillation (A8)
    CL Item
    Junctional rhythm (heart rate <=100 beats/min) (A5)
    CL Item
    Junctional rhythm (A26)
    CL Item
    Junctional tachycardia (heart rate >100 beats/min) (A24)
    CL Item
    Ectopic ventricular beats (A9)
    CL Item
    Ventricular couplets (A12)
    CL Item
    Bigeminy (A13)
    CL Item
    Trigeminy (A28)
    CL Item
    Electrical alternans (A14)
    CL Item
    R on T phenomenon (A29)
    CL Item
    Ventricular fibrillation (A18)
    CL Item
    Idioventricular rhythm (heart rate <100 beats/min) (A19)
    CL Item
    Sustained ventricular tachycardia (A10)
    CL Item
    Non-sustained ventricular tachycardia (A11)
    CL Item
    Ventricular tachycardia (A27)
    CL Item
    Monomorphic ventricular tachycardia (A30)
    CL Item
    Torsade de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (A15)
    CL Item
    Polymorphic (sustained and non-sustained) ventricular tachycardia (A31)
    CL Item
    Artificial pacemaker (A16)
    CL Item
    Other abnormal rhythm (A99)
    Other abnormal rhythm - Comment
    Item
    Other abnormal rhythm - Comment
    text
    C0232187 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [2])
    Item
    B. P-Wave and QRS Morphology
    text
    C2216025 (UMLS CUI [1])
    C0429098 (UMLS CUI [2])
    B. P-Wave and QRS Morphology
    Code List
    B. P-Wave and QRS Morphology
    CL Item
    Left atrial abnormality (P mitrale) (B1)
    CL Item
    Right atrial abnormality (P pulmonale) (B2)
    CL Item
    Right ventricular hypertrophy (B3)
    CL Item
    Intraatrial conduction delay (B5)
    CL Item
    Increased voltage consistent with left ventricular hypertrophy (D14)
    CL Item
    Other morphology (B99)
    Other P-Wave and QRS Morphology - Comment
    Item
    Other P-Wave and QRS Morphology - Comment
    text
    C2216025 (UMLS CUI [1])
    C0429098 (UMLS CUI [2])
    C0205394 (UMLS CUI [3])
    C0947611 (UMLS CUI [4])
    Item
    C. Conduction
    text
    C0232217 (UMLS CUI [1])
    C. Conduction
    Code List
    C. Conduction
    CL Item
    First degree AV block (PR interval >200msec) (C1)
    CL Item
    Second degree AV block (Mobitz type 1) (C2)
    CL Item
    Second degree AV block (Mobitz type 2) (C3)
    CL Item
    2:1 AV block (C16)
    CL Item
    Third degree AV block (C4)
    CL Item
    Left axis deviation (QRS axis more negative than -30°) (C5)
    CL Item
    Right axis deviation (QRS axis more positive than +110°) (C6)
    CL Item
    Incomplete right bundle branch block (C7)
    CL Item
    Incomplete left bundle branch block (C13)
    CL Item
    Right bundle branch block (C8)
    CL Item
    Left anterior hemiblock (synonymous to left anterior fascicular block) (C14)
    CL Item
    Left posterior hemiblock (synonymous to left posterior fascicular block) (C15)
    CL Item
    Left bundle branch block (C9)
    CL Item
    Bifascicular block (C17)
    CL Item
    Non-specific intraventricular conduction delay (QRS >= 120msec) (C10)
    CL Item
    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
    CL Item
    QT/QTc prolongation >= 500 ms (C12)
    CL Item
    AV dissociation (C18)
    CL Item
    Other conduction (C99)
    Other Conduction - Comment
    Item
    Other Conduction - Comment
    text
    C0232217 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [2])
    Item
    D. Myocaridal Infarction
    text
    C0027051 (UMLS CUI [1])
    D. Myocaridal Infarction
    Code List
    D. Myocaridal Infarction
    CL Item
    Myocaridal infarction, old (D1)
    CL Item
    Myocardial infarction, anterior (D2)
    CL Item
    Myocardial infarction, lateral (D3)
    CL Item
    Myocardial infarction, posterior (D4)
    CL Item
    Myocardial infarction, inferior (D5)
    CL Item
    Myocardial infarction, septal (D6)
    CL Item
    Myocardial infarction, Non-Q wave (D20)
    CL Item
    Other myocardial infarction (D98)
    Other Myocardial Infarction - Comment
    Item
    Other Myocardial Infarction - Comment
    text
    C0027051 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [2])
    Item
    E. Depolarisation/ Repolarisation (QRS-T)
    text
    C1395184 (UMLS CUI [1,1])
    C0948857 (UMLS CUI [1,2])
    E. Depolarisation/ Repolarisation (QRS-T)
    Code List
    E. Depolarisation/ Repolarisation (QRS-T)
    CL Item
    Non-specific ST-T changes (D7)
    CL Item
    J point elevation (D19)
    CL Item
    ST elevation (D8)
    CL Item
    ST elevation-pericarditis (D21)
    CL Item
    ST depression (D9)
    CL Item
    U waves abnormal (D10)
    CL Item
    T-wave inversion (D11)
    CL Item
    T wave peaked (D12)
    CL Item
    T waves flat (D15)
    CL Item
    T waves biphasic (D16)
    CL Item
    Notched T-waves (D18)
    CL Item
    Low QRS voltage (D13)
    CL Item
    T-wave flattening/inversion (D17)
    CL Item
    Other depolarisatoin/repolarisation (D99)
    Other Depolarisation/ Repolarisation (QRS-T) - Comment
    Item
    Other Depolarisation/ Repolarisation (QRS-T) - Comment
    text
    C1395184 (UMLS CUI [1,1])
    C0948857 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C0947611 (UMLS CUI [2])
    Item
    Other abnormalities
    text
    C0522055 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Other abnormalities
    Code List
    Other abnormalities
    CL Item
    Other abnormalities (E99)
    Other abnormalities - Comment
    Item
    Other abnormalities - Comment
    text
    C0522055 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [2])
    Item Group
    Pulmonary Function Tests
    C0024119 (UMLS CUI-1)
    Date (Pulmonary Function Tests)
    Item
    Date (Pulmonary Function Tests)
    date
    C0024119 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Pulmonary Function Test
    integer
    C0024119 (UMLS CUI [1])
    Pulmonary Function Test
    Code List
    Pulmonary Function Test
    CL Item
    FEV1 (1)
    CL Item
    FVC (2)
    CL Item
    PEFR (3)
    Item
    Planned Relative Time (Pulmonary Function Tests)
    integer
    C0024119 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    Planned Relative Time (Pulmonary Function Tests)
    Code List
    Planned Relative Time (Pulmonary Function Tests)
    CL Item
    Screening (1)
    CL Item
    Unscheduled (2)
    Actual Time of First Reading (Pulmonary Function Tests)
    Item
    Actual Time of First Reading (Pulmonary Function Tests)
    time
    C0024119 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Reading 1 (Pulmonary Function Tests)
    Item
    Reading 1 (Pulmonary Function Tests)
    float
    C0024119 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    Reading 2 (Pulmonary Function Tests)
    Item
    Reading 2 (Pulmonary Function Tests)
    float
    C0024119 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    Reading 3 (Pulmonary Function Tests)
    Item
    Reading 3 (Pulmonary Function Tests)
    float
    C0024119 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    Highest Reading (Pulmonary Function Tests) - A
    Item
    Highest Reading (Pulmonary Function Tests) - A
    float
    C0024119 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    C1522410 (UMLS CUI [1,3])
    Predicted Normal (Pulmonary Function Tests) - B
    Item
    Predicted Normal (Pulmonary Function Tests) - B
    float
    C0024119 (UMLS CUI [1,1])
    C0205307 (UMLS CUI [1,2])
    % Predicted Normal (Pulmonary Function Tests) - A/Bx100
    Item
    % Predicted Normal (Pulmonary Function Tests) - A/Bx100
    float
    C0024119 (UMLS CUI [1,1])
    C0205307 (UMLS CUI [1,2])
    C0439165 (UMLS CUI [2])
    Item Group
    Inhaler Device Training
    C0021461 (UMLS CUI-1)
    C0220931 (UMLS CUI-2)
    Has the subject received training on how to use the Diskus?
    Item
    Has the subject received training on how to use the Diskus?
    boolean
    C0021461 (UMLS CUI [1,1])
    C0220931 (UMLS CUI [1,2])
    Is the subject able to use the Diskus correctly?
    Item
    Is the subject able to use the Diskus correctly?
    boolean
    C2349182 (UMLS CUI [1,1])
    C1524063 (UMLS CUI [1,2])
    C0021461 (UMLS CUI [1,3])
    C1553480 (UMLS CUI [1,4])
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