0 Beoordelingen
ID

29673

Beschrijving

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 Lung function testing: Exhaled nitric oxide, pulmonary function tests, Methacholine Challenge. Time: Treatment Period 1, Day 29.

Link

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

Trefwoorden

Versies (1)
  1. 10-04-18 10-04-18 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

10 april 2018

DOI

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Licentie

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

    Engels

    Lung function testing - Treatment Period 1, Day 29

    1 Formulieren  
    Exhaled nitric oxide
    Beschrijving

    Exhaled nitric oxide

    Alias
    UMLS CUI-1
    C3700245 (undefined)
    Date of Exhaled nitric oxide test
    Beschrijving

    e.g., 08 JAN 04

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C3700245 (undefined)
    UMLS CUI [1,2]
    C2826247 (Test Date)
    Planned relative time
    Beschrijving

    Time relative to dosing

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    Actual time of first reading
    Beschrijving

    hr:min 00:00 - 23:59

    Datatype

    time

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

    e.g., 50.7

    Datatype

    float

    Maateenheden
    • ppb
    Alias
    UMLS CUI [1,1]
    C0028128 (nitric oxide)
    SNOMED
    409378005
    UMLS CUI [1,2]
    C0456984 (Test Result)
    SNOMED
    277775005
    ppb
    Reading 2 of Nictric Oxide
    Beschrijving

    e.g., 51.0

    Datatype

    float

    Maateenheden
    • ppb
    Alias
    UMLS CUI [1,1]
    C0028128 (nitric oxide)
    SNOMED
    409378005
    UMLS CUI [1,2]
    C0456984 (Test Result)
    SNOMED
    277775005
    ppb
    Reading 3 of Nictric Oxide
    Beschrijving

    e.g., 51.3

    Datatype

    float

    Maateenheden
    • ppb
    Alias
    UMLS CUI [1,1]
    C0028128 (nitric oxide)
    SNOMED
    409378005
    UMLS CUI [1,2]
    C0456984 (Test Result)
    SNOMED
    277775005
    ppb
    Pulmonary function tests / FEV 1
    Beschrijving

    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
    Beschrijving

    Date of FEV1

    Datatype

    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 of FEV1
    Beschrijving

    Time relative to Dosing.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,2]
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    Time of FEV1
    Beschrijving

    Hr : Min 00:00-23:59

    Datatype

    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
    Reading 1 of FEV1
    Beschrijving

    Reading 1 of FEV1

    Datatype

    float

    Maateenheden
    • 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
    Reading 2 of FEV1
    Beschrijving

    Reading 2 of FEV1

    Datatype

    float

    Maateenheden
    • 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
    Reading 3 of FEV1
    Beschrijving

    Reading 3 of FEV1

    Datatype

    float

    Maateenheden
    • 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: Pre-Methacholine Challenge
    Beschrijving

    Pulmonary function tests: Pre-Methacholine Challenge

    Alias
    UMLS CUI-1
    C0024119 (Pulmonary function tests)
    SNOMED
    23426006
    UMLS CUI-2
    C0430567 (Methacholine challenge)
    SNOMED
    252520007
    UMLS CUI-3
    C3812758 (Pre-dose Measure)
    pre-Methacholine pulmonary function test date
    Beschrijving

    pre-Methacholine pulmonary function test date

    Datatype

    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]
    C0430567 (Methacholine challenge)
    SNOMED
    252520007
    UMLS CUI [1,4]
    C3812758 (Pre-dose Measure)
    Planned relative Time
    Beschrijving

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

    Datatype

    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
    Beschrijving

    Time of FEV1

    Datatype

    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
    Beschrijving

    FEV1 Reading

    Datatype

    float

    Maateenheden
    • 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: Methacholine Challenge
    Beschrijving

    Pulmonary function tests: Methacholine Challenge

    Alias
    UMLS CUI-1
    C0748133 (PULMONARY FUNCTION TEST FEV1)
    UMLS CUI-2
    C0430567 (Methacholine challenge)
    SNOMED
    252520007
    Methacholine Challenge Date
    Beschrijving

    Methacholine Challenge Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0748133 (PULMONARY FUNCTION TEST FEV1)
    UMLS CUI [1,3]
    C0430567 (Methacholine challenge)
    SNOMED
    252520007
    Inhaled Substance
    Beschrijving

    Inhaled Substance

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0205535 (Inhalation Route of Drug Administration)
    LOINC
    LA9427-1
    UMLS CUI [1,2]
    C0600370 (methacholine)
    SNOMED
    53584007
    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)
    Beschrijving

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

    Datatype

    text

    Maateenheden
    • mg/mL
    Alias
    UMLS CUI [1,1]
    C1446561 (Concentration measurement)
    LOINC
    LP6194-7
    UMLS CUI [1,2]
    C0600370 (methacholine)
    SNOMED
    53584007
    Challenge Concentration (Historical concentration)
    Beschrijving

    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 Methacholine (provocholine) until a ≥20percent fall in FEV1 from the baseline saline value is achieved. Use 0.000 for saline inhaltation.

    Datatype

    float

    Maateenheden
    • mg/mL
    Alias
    UMLS CUI [1,1]
    C1446561 (Concentration measurement)
    LOINC
    LP6194-7
    UMLS CUI [1,2]
    C0600370 (methacholine)
    SNOMED
    53584007
    mg/mL
    Start Time of Inhalation
    Beschrijving

    Fill in only for saline inhalation and new subjects.

    Datatype

    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
    Beschrijving

    Stop Time of Inhalation

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

    Pulmonary function time

    Datatype

    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
    Beschrijving

    FEV1 Result

    Datatype

    float

    Maateenheden
    • L
    Alias
    UMLS CUI [1,1]
    C0429706 (Forced expiratory volume in 1 second finding)
    SNOMED
    59328004
    UMLS CUI [1,2]
    C0430567 (Methacholine challenge)
    SNOMED
    252520007
    L
    Pulmonary function tests: Post-Methacholine Challenge
    Beschrijving

    Pulmonary function tests: Post-Methacholine Challenge

    Alias
    UMLS CUI-1
    C0231921 (Pulmonary function)
    SNOMED
    106053004
    LOINC
    LP99358-1
    UMLS CUI-2
    C0430567 (Methacholine challenge)
    SNOMED
    252520007
    UMLS CUI-3
    C0439568 (Post-dose)
    SNOMED
    255566006
    Date of post-challenge FEV1
    Beschrijving

    Date of post-challenge FEV1

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

    Record use of rescue Salbutamol on the Concomitant Medications page.

    Datatype

    float

    Maateenheden
    • 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
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    Similar models

    Lung function testing - Treatment Period 1, Day 29

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Exhaled nitric oxide
    C3700245 (UMLS CUI-1)
    Date of Exhaled nitric oxide test
    Item
    Date of Exhaled nitric oxide test
    date
    C3700245 (UMLS CUI [1,1])
    C2826247 (UMLS CUI [1,2])
    Item
    Planned relative time
    text
    C0439564 (UMLS CUI [1])
    Planned relative time
    Code List
    Planned relative time
    CL Item
    unscheduled (unscheduled)
    (Comment:en)
    CL Item
    within 1 hr post-challenge (within 1 hr post-challenge)
    (Comment:en)
    CL Item
    pre-challenge (pre-challenge)
    (Comment:en)
    Actual time of first reading
    Item
    Actual time of first reading
    time
    C0040223 (UMLS CUI [1,1])
    C3700245 (UMLS CUI [1,2])
    Reading 1 of Nictric Oxide
    Item
    Reading 1 of Nictric Oxide
    float
    C0028128 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Reading 2 of Nictric Oxide
    Item
    Reading 2 of Nictric Oxide
    float
    C0028128 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Reading 3 of Nictric Oxide
    Item
    Reading 3 of Nictric Oxide
    float
    C0028128 (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 of FEV1
    text
    C0439564 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    Planned relative Time of FEV1
    Code List
    Planned relative Time of FEV1
    CL Item
    unscheduled (unscheduled)
    (Comment:en)
    CL Item
    pre-challenge (pre-challenge)
    (Comment:en)
    CL Item
    post-challenge (discharge) (post-challenge (discharge))
    (Comment:en)
    Time of FEV1
    Item
    Time of FEV1
    time
    C0040223 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    Reading 1 of FEV1
    Item
    Reading 1 of FEV1
    float
    C0456984 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    Reading 2 of FEV1
    Item
    Reading 2 of FEV1
    float
    C0456984 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    Reading 3 of FEV1
    Item
    Reading 3 of FEV1
    float
    C0456984 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    Item Group
    Pulmonary function tests: Pre-Methacholine Challenge
    C0024119 (UMLS CUI-1)
    C0430567 (UMLS CUI-2)
    C3812758 (UMLS CUI-3)
    pre-Methacholine pulmonary function test date
    Item
    pre-Methacholine pulmonary function test date
    date
    C0011008 (UMLS CUI [1,1])
    C0024119 (UMLS CUI [1,2])
    C0430567 (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: Methacholine Challenge
    C0748133 (UMLS CUI-1)
    C0430567 (UMLS CUI-2)
    Methacholine Challenge Date
    Item
    Methacholine Challenge Date
    date
    C0011008 (UMLS CUI [1,1])
    C0748133 (UMLS CUI [1,2])
    C0430567 (UMLS CUI [1,3])
    Item
    Inhaled Substance
    text
    C0205535 (UMLS CUI [1,1])
    C0600370 (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
    Metacholine (Metacholine)
    Item
    Challenge Concentration (New Subjects)
    text
    C1446561 (UMLS CUI [1,1])
    C0600370 (UMLS CUI [1,2])
    Challenge Concentration (New Subjects)
    Code List
    Challenge Concentration (New Subjects)
    CL Item
    0.000 (0.000)
    CL Item
    0.03125 (0.03125)
    CL Item
    0.06250 (0.06250)
    CL Item
    0.125 (0.125)
    CL Item
    0.25 (0.25)
    CL Item
    0.5 (0.5)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    4 (4)
    CL Item
    8 (8)
    CL Item
    16 (16)
    CL Item
    32 (32)
    Challenge Concentration (Historical concentration)
    Item
    Challenge Concentration (Historical concentration)
    float
    C1446561 (UMLS CUI [1,1])
    C0600370 (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])
    C0430567 (UMLS CUI [1,2])
    Item Group
    Pulmonary function tests: Post-Methacholine Challenge
    C0231921 (UMLS CUI-1)
    C0430567 (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])
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