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ID

29605

Description

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Screening Part 4 - ECG and Pulmonary function parts Exhaled nitric oxide and AMP Challenge.

Link

https://clinicaltrials.gov/ct2/show/NCT00318630

Keywords

Versions (2)
  1. 10.04.18 10.04.18 - Sarah Riepenhausen
  2. 10.04.18 10.04.18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

10. April 2018

DOI

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License

Creative Commons BY-NC 3.0
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    GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

    English

    Screening Part 4 - ECG and Pulmonary function (exhaled nitric oxide and AMP Challenge)

    1 forms  
    12-Lead ECG
    Description

    12-Lead ECG

    Alias
    UMLS CUI-1
    C0430456
    ECG number
    Description

    Three ECG strips more than 1 minute apart will be recorded (scheduled). Unscheduled ECGs are possible, too.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0237753
    Start Date of ECG
    Description

    Start Date of ECG

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0808070
    Planned Relative Time
    Description

    Planned Relative Time

    Data type

    text

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

    Start Time of ECG

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1301880
    Ventricular rate
    Description

    Ventricular rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C2189285
    beats/min
    PR interval
    Description

    PR interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    QRS duration
    Description

    QRS duration

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0429025
    UMLS CUI [1,2]
    C0430456
    msec
    Uncorrected QT interval
    Description

    Uncorrected QT interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1287082
    UMLS CUI [1,3]
    C4072785
    msec
    QTc interval
    Description

    QTc interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0855331
    msec
    Result of ECG
    Description

    Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0456984
    Exhaled nitric oxide
    Description

    Exhaled nitric oxide

    Alias
    UMLS CUI-1
    C3700245
    Exhaled nitric oxide - Date
    Description

    Exhaled nitric oxide - Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3700245
    UMLS CUI [1,2]
    C0011008
    Planned relative time
    Description

    Planned relative time

    Data type

    text

    Actual Time of First Reading
    Description

    Actual Time of First Reading

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C3700245
    UMLS CUI [1,2]
    C0040223
    Reading 1
    Description

    Reading 1

    Data type

    float

    Measurement units
    • ppb
    Alias
    UMLS CUI [1,1]
    C3700245
    UMLS CUI [1,2]
    C0456984
    ppb
    Reading 2
    Description

    Reading 2

    Data type

    float

    Measurement units
    • ppb
    Alias
    UMLS CUI [1,1]
    C3700245
    UMLS CUI [1,2]
    C0456984
    ppb
    Reading 3
    Description

    Reading 3

    Data type

    float

    Measurement units
    • ppb
    Alias
    UMLS CUI [1,1]
    C3700245
    UMLS CUI [1,2]
    C0456984
    ppb
    Pulmonary function tests / FEV 1
    Description

    Pulmonary function tests / FEV 1

    Alias
    UMLS CUI-1
    C0024119
    UMLS CUI-2
    C0429706
    Date of FEV1
    Description

    Date of FEV1

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0429706
    Planned Relative Time
    Description

    Time relative to dosing

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0748133
    Pulmonary Function Time
    Description

    Pulmonary Function Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0024119
    FEV1 Reading 1
    Description

    FEV1 Reading 1

    Data type

    float

    Measurement units
    • L
    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0429706
    L
    FEV1 Reading 2
    Description

    FEV1 Reading 2

    Data type

    float

    Measurement units
    • L
    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0429706
    L
    FEV1 Reading 3
    Description

    FEV1 Reading 3

    Data type

    float

    Measurement units
    • L
    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0429706
    L
    FEV1 Reading 1
    Description

    Value A in investigator Calculation

    Data type

    float

    Measurement units
    • L
    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0429706
    L
    FEV1 predicted normal
    Description

    Value B in Investigator Calculation

    Data type

    float

    Measurement units
    • L
    Alias
    UMLS CUI [1,1]
    C0748133
    UMLS CUI [1,2]
    C0086715
    L
    FEV1 percent predicted normal
    Description

    Investigator Calculation: A / B x 100 FEV1 must be > 70% of predicted at Screening.

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C0730561
    %
    Pulmonary function tests: Pre-AMP Challenge
    Description

    Pulmonary function tests: Pre-AMP Challenge

    Alias
    UMLS CUI-1
    C0024119
    UMLS CUI-2
    C1096479
    UMLS CUI-3
    C3812758
    pre-AMP pulmonary function test date
    Description

    pre-AMP pulmonary function test date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0024119
    UMLS CUI [1,3]
    C1096479
    UMLS CUI [1,4]
    C3812758
    Planned relative Time
    Description

    Time relative to start of challenge. 3 pre-saline measurements are required.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0748133
    Time of FEV1
    Description

    Time of FEV1

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0429706
    FEV1 Reading
    Description

    FEV1 Reading

    Data type

    float

    Measurement units
    • L
    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0429706
    L
    Pulmonary function tests: AMP Challenge
    Description

    Pulmonary function tests: AMP Challenge

    Alias
    UMLS CUI-1
    C0024119
    UMLS CUI-2
    C1096479
    AMP-Challenge Date
    Description

    AMP-Challenge Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1096479
    Inhaled Substance
    Description

    Inhaled Substance

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205535
    UMLS CUI [1,2]
    C0001465
    UMLS CUI [2,1]
    C0205535
    UMLS CUI [2,2]
    C0036082
    Challenge Concentration (New subjects)
    Description

    Following the baseline assessment in which FEV1 is measured after inhalation of saline, subjects are to inhale doubling increments of AMP until a ≥20percent fall in FEV1 from the baseline saline value is achieved. 0.000 is the concentration value for saline.

    Data type

    text

    Measurement units
    • mg/mL
    Alias
    UMLS CUI [1,1]
    C1446561
    UMLS CUI [1,2]
    C0001465
    Challenge Concentration (Historical concentration)
    Description

    Use this item, if historical concentrations instead of the concentrations given in the item "challenge concentration (New Subjects)" are used. Following the baseline assessment in which FEV1 is measured after inhalation of saline, subjects are to inhale doubling increments of AMP until a ≥20percent fall in FEV1 from the baseline saline value is achieved. Use 0.000 for saline inhaltation.

    Data type

    float

    Measurement units
    • mg/mL
    Alias
    UMLS CUI [1,1]
    C1446561
    UMLS CUI [1,2]
    C0001465
    mg/mL
    Start Time of Inhalation
    Description

    Fill in only for saline inhalation.

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C0001559
    Stop Time of Inhalation
    Description

    Stop Time of Inhalation

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0001559
    Planned relative Time of FEV1
    Description

    Both timepoints must be filled after each inhalation. Time relative to stop time of inhalation.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0205535
    UMLS CUI [1,3]
    C0748133
    Pulmonary function time
    Description

    Pulmonary function time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0429706
    FEV1 Result
    Description

    FEV1 Result

    Data type

    float

    Measurement units
    • L
    Alias
    UMLS CUI [1,1]
    C0429706
    UMLS CUI [1,2]
    C1096479
    L
    Pulmonary function tests: Post-AMP Challenge
    Description

    Pulmonary function tests: Post-AMP Challenge

    Alias
    UMLS CUI-1
    C0231921
    UMLS CUI-2
    C1096479
    UMLS CUI-3
    C0439568
    Date of post-challenge FEV1
    Description

    Date of post-challenge FEV1

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0429706
    UMLS CUI [1,3]
    C0439568
    Time of post-challenge FEV1
    Description

    Time relative to end of challenge: Post-challenge 6 measurements are required.

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0429706
    UMLS CUI [1,3]
    C0439568
    Result of post-challenge FEV1
    Description

    Record use of rescue Salbutamol on the Concomitant Medications page.

    Data type

    float

    Measurement units
    • L
    Alias
    UMLS CUI [1,1]
    C0429706
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C0439568
    L
    PC20 (AMP Challenge)
    Description

    PC20 (AMP Challenge)

    Alias
    UMLS CUI-1
    C1446561
    UMLS CUI-2
    C0001465
    UMLS CUI-3
    C0429706
    UMLS CUI-4
    C0547047
    Date of challenge
    Description

    Date of challenge

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1096479
    PC20
    Description

    Provocative concentration resulting in a 20% reduction in FEV1.

    Data type

    float

    Measurement units
    • mg/mL
    Alias
    UMLS CUI [1,1]
    C1446561
    UMLS CUI [1,2]
    C0001465
    UMLS CUI [2,1]
    C0429706
    UMLS CUI [2,2]
    C0547047
    mg/mL
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    Screening Part 4 - ECG and Pulmonary function (exhaled nitric oxide and AMP Challenge)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    12-Lead ECG
    C0430456 (UMLS CUI-1)
    Item
    ECG number
    text
    C1623258 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    ECG number
    Code List
    ECG number
    CL Item
    ECG1 (ECG1)
    CL Item
    ECG2 (ECG2)
    CL Item
    ECG3 (ECG3)
    CL Item
    ECG4 (ECG4)
    CL Item
    ECG5 (ECG5)
    CL Item
    ECG6 (ECG6)
    Start Date of ECG
    Item
    Start Date of ECG
    date
    C0430456 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item
    Planned Relative Time
    text
    C0430456 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    Planned Relative Time
    Code List
    Planned Relative Time
    CL Item
    screening (screening)
    CL Item
    unscheduled (unscheduled)
    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
    float
    C0429087 (UMLS CUI [1])
    QRS duration
    Item
    QRS duration
    float
    C0429025 (UMLS CUI [1,1])
    C0430456 (UMLS CUI [1,2])
    Uncorrected QT interval
    Item
    Uncorrected QT interval
    float
    C0430456 (UMLS CUI [1,1])
    C1287082 (UMLS CUI [1,2])
    C4072785 (UMLS CUI [1,3])
    QTc interval
    Item
    QTc interval
    float
    C0855331 (UMLS CUI [1])
    Item
    Result of ECG
    integer
    C1623258 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Result of ECG
    Code List
    Result of 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
    Exhaled nitric oxide
    C3700245 (UMLS CUI-1)
    Exhaled nitric oxide - Date
    Item
    Exhaled nitric oxide - Date
    date
    C3700245 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Planned relative time
    text
    Planned relative time
    Code List
    Planned relative time
    CL Item
    screening (screening)
    CL Item
    unscheduled (unscheduled)
    Actual Time of First Reading
    Item
    Actual Time of First Reading
    time
    C3700245 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Reading 1
    Item
    Reading 1
    float
    C3700245 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Reading 2
    Item
    Reading 2
    float
    C3700245 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Reading 3
    Item
    Reading 3
    float
    C3700245 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Item Group
    Pulmonary function tests / FEV 1
    C0024119 (UMLS CUI-1)
    C0429706 (UMLS CUI-2)
    Date of FEV1
    Item
    Date of FEV1
    date
    C0011008 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    Item
    Planned Relative Time
    text
    C0439564 (UMLS CUI [1,1])
    C0748133 (UMLS CUI [1,2])
    Planned Relative Time
    Code List
    Planned Relative Time
    CL Item
    Screening (Screening)
    CL Item
    Unscheduled (Unscheduled)
    Pulmonary Function Time
    Item
    Pulmonary Function Time
    time
    C0040223 (UMLS CUI [1,1])
    C0024119 (UMLS CUI [1,2])
    FEV1 Reading 1
    Item
    FEV1 Reading 1
    float
    C0456984 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    FEV1 Reading 2
    Item
    FEV1 Reading 2
    float
    C0456984 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    FEV1 Reading 3
    Item
    FEV1 Reading 3
    float
    C0456984 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    FEV1 Highest Reading
    Item
    FEV1 Reading 1
    float
    C0456984 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    FEV1 Predicted normal
    Item
    FEV1 predicted normal
    float
    C0748133 (UMLS CUI [1,1])
    C0086715 (UMLS CUI [1,2])
    FEV1 percent predicted normal
    Item
    FEV1 percent predicted normal
    float
    C0730561 (UMLS CUI [1])
    Item Group
    Pulmonary function tests: Pre-AMP Challenge
    C0024119 (UMLS CUI-1)
    C1096479 (UMLS CUI-2)
    C3812758 (UMLS CUI-3)
    pre-AMP pulmonary function test date
    Item
    pre-AMP pulmonary function test date
    date
    C0011008 (UMLS CUI [1,1])
    C0024119 (UMLS CUI [1,2])
    C1096479 (UMLS CUI [1,3])
    C3812758 (UMLS CUI [1,4])
    Item
    Planned relative Time
    text
    C0439564 (UMLS CUI [1,1])
    C0748133 (UMLS CUI [1,2])
    Planned relative time
    Code List
    Planned relative Time
    CL Item
    pre-saline (pre-saline)
    CL Item
    unscheduled (unscheduled)
    Time of FEV1
    Item
    Time of FEV1
    time
    C0040223 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    FEV1 Reading
    Item
    FEV1 Reading
    float
    C0456984 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    Item Group
    Pulmonary function tests: AMP Challenge
    C0024119 (UMLS CUI-1)
    C1096479 (UMLS CUI-2)
    AMP-Challenge Date
    Item
    AMP-Challenge Date
    date
    C0011008 (UMLS CUI [1,1])
    C1096479 (UMLS CUI [1,2])
    Item
    Inhaled Substance
    text
    C0205535 (UMLS CUI [1,1])
    C0001465 (UMLS CUI [1,2])
    C0205535 (UMLS CUI [2,1])
    C0036082 (UMLS CUI [2,2])
    Inhaled Substance
    Code List
    Inhaled Substance
    CL Item
    Saline (Saline)
    CL Item
    Saline, unscheduled (Saline, unscheduled)
    CL Item
    AMP (AMP)
    Item
    Challenge Concentration (New subjects)
    text
    C1446561 (UMLS CUI [1,1])
    C0001465 (UMLS CUI [1,2])
    Challenge Concentration (New Subjects)
    Code List
    Challenge Concentration (New subjects)
    CL Item
    0.000 (0.000)
    CL Item
    0.039 (0.039)
    CL Item
    0.078 (0.078)
    CL Item
    0.156 (0.156)
    CL Item
    0.3125 (0.3125)
    CL Item
    0.625 (0.625)
    CL Item
    1.25 (1.25)
    CL Item
    2.5 (2.5)
    CL Item
    5 (5)
    CL Item
    10 (10)
    CL Item
    20 (20)
    CL Item
    40 (40)
    CL Item
    80 (80)
    CL Item
    160 (160)
    CL Item
    320 (320)
    Challenge Concentration (Historical Concentration)
    Item
    Challenge Concentration (Historical concentration)
    float
    C1446561 (UMLS CUI [1,1])
    C0001465 (UMLS CUI [1,2])
    Start Time of Inhalation
    Item
    Start Time of Inhalation
    time
    C1301880 (UMLS CUI [1,1])
    C0001559 (UMLS CUI [1,2])
    Stop Time of Inhalation
    Item
    Stop Time of Inhalation
    time
    C1522314 (UMLS CUI [1,1])
    C0001559 (UMLS CUI [1,2])
    Item
    Planned relative Time of FEV1
    text
    C0439564 (UMLS CUI [1,1])
    C0205535 (UMLS CUI [1,2])
    C0748133 (UMLS CUI [1,3])
    Planned relative Time of FEV1
    Code List
    Planned relative Time of FEV1
    CL Item
    60 secs post-inhalation (60 secs post-inhalation)
    CL Item
    180 secs post-inhalation (180 secs post-inhalation)
    Pulmonary function time
    Item
    Pulmonary function time
    time
    C0040223 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    FEV1 Result
    Item
    FEV1 Result
    float
    C0429706 (UMLS CUI [1,1])
    C1096479 (UMLS CUI [1,2])
    Item Group
    Pulmonary function tests: Post-AMP Challenge
    C0231921 (UMLS CUI-1)
    C1096479 (UMLS CUI-2)
    C0439568 (UMLS CUI-3)
    Date of post-challenge FEV1
    Item
    Date of post-challenge FEV1
    date
    C0011008 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Time of post-challenge FEV1
    Item
    Time of post-challenge FEV1
    time
    C0040223 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Result of post-challenge FEV1
    Item
    Result of post-challenge FEV1
    float
    C0429706 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Item Group
    PC20 (AMP Challenge)
    C1446561 (UMLS CUI-1)
    C0001465 (UMLS CUI-2)
    C0429706 (UMLS CUI-3)
    C0547047 (UMLS CUI-4)
    Date of challenge
    Item
    Date of challenge
    date
    C0011008 (UMLS CUI [1,1])
    C1096479 (UMLS CUI [1,2])
    PC20
    Item
    PC20
    float
    C1446561 (UMLS CUI [1,1])
    C0001465 (UMLS CUI [1,2])
    C0429706 (UMLS CUI [2,1])
    C0547047 (UMLS CUI [2,2])
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