0 Evaluaciones

ID

29605

Descripción

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

Palabras clave

  1. 10/4/18 10/4/18 - Sarah Riepenhausen
  2. 10/4/18 10/4/18 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

10 de abril de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

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

    12-Lead ECG
    Descripción

    12-Lead ECG

    Alias
    UMLS CUI-1
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    ECG number
    Descripción

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

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1623258 (Electrocardiography)
    SNOMED
    29303009
    LOINC
    LP6244-0
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Start Date of ECG
    Descripción

    Start Date of ECG

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI [1,2]
    C0808070 (Start Date)
    Planned Relative Time
    Descripción

    Planned Relative Time

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI [1,2]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    Start Time of ECG
    Descripción

    Start Time of ECG

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI [1,2]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    Ventricular rate
    Descripción

    Ventricular rate

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C2189285 (electrocardiogram: ventricular rate)
    beats/min
    PR interval
    Descripción

    PR interval

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0429087 (Electrocardiogram: P-R interval)
    SNOMED
    365411005
    msec
    QRS duration
    Descripción

    QRS duration

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1,1]
    C0429025 (QRS complex duration (observable entity))
    SNOMED
    251208001
    LOINC
    LP31031-5
    UMLS CUI [1,2]
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    msec
    Uncorrected QT interval
    Descripción

    Uncorrected QT interval

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI [1,2]
    C1287082 (QT interval - finding)
    SNOMED
    365417009
    UMLS CUI [1,3]
    C4072785 (uncorrected)
    LOINC
    LP200592-6
    msec
    QTc interval
    Descripción

    QTc interval

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0855331 (Electrocardiogram QT corrected interval)
    msec
    Result of ECG
    Descripción

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

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1623258 (Electrocardiography)
    SNOMED
    29303009
    LOINC
    LP6244-0
    UMLS CUI [1,2]
    C0456984 (Test Result)
    SNOMED
    277775005
    Exhaled nitric oxide
    Descripción

    Exhaled nitric oxide

    Alias
    UMLS CUI-1
    C3700245 (undefined)
    Exhaled nitric oxide - Date
    Descripción

    Exhaled nitric oxide - Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C3700245 (undefined)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Planned relative time
    Descripción

    Planned relative time

    Tipo de datos

    text

    Actual Time of First Reading
    Descripción

    Actual Time of First Reading

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C3700245 (undefined)
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Reading 1
    Descripción

    Reading 1

    Tipo de datos

    float

    Unidades de medida
    • ppb
    Alias
    UMLS CUI [1,1]
    C3700245 (undefined)
    UMLS CUI [1,2]
    C0456984 (Test Result)
    SNOMED
    277775005
    ppb
    Reading 2
    Descripción

    Reading 2

    Tipo de datos

    float

    Unidades de medida
    • ppb
    Alias
    UMLS CUI [1,1]
    C3700245 (undefined)
    UMLS CUI [1,2]
    C0456984 (Test Result)
    SNOMED
    277775005
    ppb
    Reading 3
    Descripción

    Reading 3

    Tipo de datos

    float

    Unidades de medida
    • ppb
    Alias
    UMLS CUI [1,1]
    C3700245 (undefined)
    UMLS CUI [1,2]
    C0456984 (Test Result)
    SNOMED
    277775005
    ppb
    Pulmonary function tests / FEV 1
    Descripción

    Pulmonary function tests / FEV 1

    Alias
    UMLS CUI-1
    C0024119 (Pulmonary function tests)
    SNOMED
    23426006
    UMLS CUI-2
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    Date of FEV1
    Descripción

    Date of FEV1

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    Planned Relative Time
    Descripción

    Time relative to dosing

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,2]
    C0748133 (PULMONARY FUNCTION TEST FEV1)
    Pulmonary Function Time
    Descripción

    Pulmonary Function Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0024119 (Pulmonary function tests)
    SNOMED
    23426006
    FEV1 Reading 1
    Descripción

    FEV1 Reading 1

    Tipo de datos

    float

    Unidades de medida
    • L
    Alias
    UMLS CUI [1,1]
    C0456984 (Test Result)
    SNOMED
    277775005
    UMLS CUI [1,2]
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    L
    FEV1 Reading 2
    Descripción

    FEV1 Reading 2

    Tipo de datos

    float

    Unidades de medida
    • L
    Alias
    UMLS CUI [1,1]
    C0456984 (Test Result)
    SNOMED
    277775005
    UMLS CUI [1,2]
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    L
    FEV1 Reading 3
    Descripción

    FEV1 Reading 3

    Tipo de datos

    float

    Unidades de medida
    • L
    Alias
    UMLS CUI [1,1]
    C0456984 (Test Result)
    SNOMED
    277775005
    UMLS CUI [1,2]
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    L
    FEV1 Reading 1
    Descripción

    Value A in investigator Calculation

    Tipo de datos

    float

    Unidades de medida
    • L
    Alias
    UMLS CUI [1,1]
    C0456984 (Test Result)
    SNOMED
    277775005
    UMLS CUI [1,2]
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    L
    FEV1 predicted normal
    Descripción

    Value B in Investigator Calculation

    Tipo de datos

    float

    Unidades de medida
    • L
    Alias
    UMLS CUI [1,1]
    C0748133 (PULMONARY FUNCTION TEST FEV1)
    UMLS CUI [1,2]
    C0086715 (Normal Range)
    SNOMED
    260395002
    L
    FEV1 percent predicted normal
    Descripción

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

    Tipo de datos

    float

    Unidades de medida
    • %
    Alias
    UMLS CUI [1]
    C0730561 (Percent predicted FEV1)
    SNOMED
    313223002
    %
    Pulmonary function tests: Pre-AMP Challenge
    Descripción

    Pulmonary function tests: Pre-AMP Challenge

    Alias
    UMLS CUI-1
    C0024119 (Pulmonary function tests)
    SNOMED
    23426006
    UMLS CUI-2
    C1096479 (Pulmonary adenosine 5'-monophosphate challenge test)
    UMLS CUI-3
    C3812758 (Pre-dose Measure)
    pre-AMP pulmonary function test date
    Descripción

    pre-AMP pulmonary function test date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0024119 (Pulmonary function tests)
    SNOMED
    23426006
    UMLS CUI [1,3]
    C1096479 (Pulmonary adenosine 5'-monophosphate challenge test)
    UMLS CUI [1,4]
    C3812758 (Pre-dose Measure)
    Planned relative Time
    Descripción

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

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,2]
    C0748133 (PULMONARY FUNCTION TEST FEV1)
    Time of FEV1
    Descripción

    Time of FEV1

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    FEV1 Reading
    Descripción

    FEV1 Reading

    Tipo de datos

    float

    Unidades de medida
    • L
    Alias
    UMLS CUI [1,1]
    C0456984 (Test Result)
    SNOMED
    277775005
    UMLS CUI [1,2]
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    L
    Pulmonary function tests: AMP Challenge
    Descripción

    Pulmonary function tests: AMP Challenge

    Alias
    UMLS CUI-1
    C0024119 (Pulmonary function tests)
    SNOMED
    23426006
    UMLS CUI-2
    C1096479 (Pulmonary adenosine 5'-monophosphate challenge test)
    AMP-Challenge Date
    Descripción

    AMP-Challenge Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C1096479 (Pulmonary adenosine 5'-monophosphate challenge test)
    Inhaled Substance
    Descripción

    Inhaled Substance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0205535 (Inhalation Route of Drug Administration)
    LOINC
    LA9427-1
    UMLS CUI [1,2]
    C0001465 (adenosine monophosphate)
    SNOMED
    4864008
    UMLS CUI [2,1]
    C0205535 (Inhalation Route of Drug Administration)
    LOINC
    LA9427-1
    UMLS CUI [2,2]
    C0036082 (Saline Solution)
    SNOMED
    373757009
    LOINC
    LP31577-7
    Challenge Concentration (New subjects)
    Descripción

    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.

    Tipo de datos

    text

    Unidades de medida
    • mg/mL
    Alias
    UMLS CUI [1,1]
    C1446561 (Concentration measurement)
    LOINC
    LP6194-7
    UMLS CUI [1,2]
    C0001465 (adenosine monophosphate)
    SNOMED
    4864008
    Challenge Concentration (Historical concentration)
    Descripción

    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.

    Tipo de datos

    float

    Unidades de medida
    • mg/mL
    Alias
    UMLS CUI [1,1]
    C1446561 (Concentration measurement)
    LOINC
    LP6194-7
    UMLS CUI [1,2]
    C0001465 (adenosine monophosphate)
    SNOMED
    4864008
    mg/mL
    Start Time of Inhalation
    Descripción

    Fill in only for saline inhalation.

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    UMLS CUI [1,2]
    C0001559 (Inhalation Drug Administration)
    SNOMED
    243132000
    Stop Time of Inhalation
    Descripción

    Stop Time of Inhalation

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1522314 (End Time)
    SNOMED
    397898000
    UMLS CUI [1,2]
    C0001559 (Inhalation Drug Administration)
    SNOMED
    243132000
    Planned relative Time of FEV1
    Descripción

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

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,2]
    C0205535 (Inhalation Route of Drug Administration)
    LOINC
    LA9427-1
    UMLS CUI [1,3]
    C0748133 (PULMONARY FUNCTION TEST FEV1)
    Pulmonary function time
    Descripción

    Pulmonary function time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    FEV1 Result
    Descripción

    FEV1 Result

    Tipo de datos

    float

    Unidades de medida
    • L
    Alias
    UMLS CUI [1,1]
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    UMLS CUI [1,2]
    C1096479 (Pulmonary adenosine 5'-monophosphate challenge test)
    L
    Pulmonary function tests: Post-AMP Challenge
    Descripción

    Pulmonary function tests: Post-AMP Challenge

    Alias
    UMLS CUI-1
    C0231921 (Pulmonary function)
    SNOMED
    106053004
    LOINC
    LP99358-1
    UMLS CUI-2
    C1096479 (Pulmonary adenosine 5'-monophosphate challenge test)
    UMLS CUI-3
    C0439568 (Post-dose)
    SNOMED
    255566006
    Date of post-challenge FEV1
    Descripción

    Date of post-challenge FEV1

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    UMLS CUI [1,3]
    C0439568 (Post-dose)
    SNOMED
    255566006
    Time of post-challenge FEV1
    Descripción

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

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    UMLS CUI [1,3]
    C0439568 (Post-dose)
    SNOMED
    255566006
    Result of post-challenge FEV1
    Descripción

    Record use of rescue Salbutamol on the Concomitant Medications page.

    Tipo de datos

    float

    Unidades de medida
    • L
    Alias
    UMLS CUI [1,1]
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    UMLS CUI [1,2]
    C1274040 (Result)
    SNOMED
    394617004
    UMLS CUI [1,3]
    C0439568 (Post-dose)
    SNOMED
    255566006
    L
    PC20 (AMP Challenge)
    Descripción

    PC20 (AMP Challenge)

    Alias
    UMLS CUI-1
    C1446561 (Concentration measurement)
    LOINC
    LP6194-7
    UMLS CUI-2
    C0001465 (adenosine monophosphate)
    SNOMED
    4864008
    UMLS CUI-3
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    UMLS CUI-4
    C0547047 (Decrease)
    SNOMED
    260370003
    Date of challenge
    Descripción

    Date of challenge

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C1096479 (Pulmonary adenosine 5'-monophosphate challenge test)
    PC20
    Descripción

    Provocative concentration resulting in a 20% reduction in FEV1.

    Tipo de datos

    float

    Unidades de medida
    • mg/mL
    Alias
    UMLS CUI [1,1]
    C1446561 (Concentration measurement)
    LOINC
    LP6194-7
    UMLS CUI [1,2]
    C0001465 (adenosine monophosphate)
    SNOMED
    4864008
    UMLS CUI [2,1]
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    UMLS CUI [2,2]
    C0547047 (Decrease)
    SNOMED
    260370003
    mg/mL

    Similar models

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

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    12-Lead ECG
    C0430456 (UMLS CUI-1)
    Item
    ECG number
    text
    C1623258 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    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])
    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])
    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
    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])
    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])
    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])
    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])
    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])
    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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