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ID

29673

Beskrivning

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.

Länk

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

Nyckelord

Versioner (1)
  1. 2018-04-10 2018-04-10 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

10 april 2018

DOI

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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

    Engelsk

    Lung function testing - Treatment Period 1, Day 29

    1 Formulär  
    Exhaled nitric oxide
    Beskrivning

    Exhaled nitric oxide

    Alias
    UMLS CUI-1
    C3700245
    Date of Exhaled nitric oxide test
    Beskrivning

    e.g., 08 JAN 04

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C3700245
    UMLS CUI [1,2]
    C2826247
    Planned relative time
    Beskrivning

    Time relative to dosing

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0439564
    Actual time of first reading
    Beskrivning

    hr:min 00:00 - 23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C3700245
    Reading 1 of Nictric Oxide
    Beskrivning

    e.g., 50.7

    Datatyp

    float

    Måttenheter
    • ppb
    Alias
    UMLS CUI [1,1]
    C0028128
    UMLS CUI [1,2]
    C0456984
    ppb
    Reading 2 of Nictric Oxide
    Beskrivning

    e.g., 51.0

    Datatyp

    float

    Måttenheter
    • ppb
    Alias
    UMLS CUI [1,1]
    C0028128
    UMLS CUI [1,2]
    C0456984
    ppb
    Reading 3 of Nictric Oxide
    Beskrivning

    e.g., 51.3

    Datatyp

    float

    Måttenheter
    • ppb
    Alias
    UMLS CUI [1,1]
    C0028128
    UMLS CUI [1,2]
    C0456984
    ppb
    Pulmonary function tests / FEV 1
    Beskrivning

    Pulmonary function tests / FEV 1

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

    Date of FEV1

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0429706
    Planned relative Time of FEV1
    Beskrivning

    Time relative to Dosing.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0429706
    Time of FEV1
    Beskrivning

    Hr : Min 00:00-23:59

    Datatyp

    time

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

    Reading 1 of FEV1

    Datatyp

    float

    Måttenheter
    • L
    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0429706
    L
    Reading 2 of FEV1
    Beskrivning

    Reading 2 of FEV1

    Datatyp

    float

    Måttenheter
    • L
    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0429706
    L
    Reading 3 of FEV1
    Beskrivning

    Reading 3 of FEV1

    Datatyp

    float

    Måttenheter
    • L
    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0429706
    L
    Pulmonary function tests: Pre-Methacholine Challenge
    Beskrivning

    Pulmonary function tests: Pre-Methacholine Challenge

    Alias
    UMLS CUI-1
    C0024119
    UMLS CUI-2
    C0430567
    UMLS CUI-3
    C3812758
    pre-Methacholine pulmonary function test date
    Beskrivning

    pre-Methacholine pulmonary function test date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0024119
    UMLS CUI [1,3]
    C0430567
    UMLS CUI [1,4]
    C3812758
    Planned relative Time
    Beskrivning

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

    Datatyp

    text

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

    Time of FEV1

    Datatyp

    time

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

    FEV1 Reading

    Datatyp

    float

    Måttenheter
    • L
    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0429706
    L
    Pulmonary function tests: Methacholine Challenge
    Beskrivning

    Pulmonary function tests: Methacholine Challenge

    Alias
    UMLS CUI-1
    C0748133
    UMLS CUI-2
    C0430567
    Methacholine Challenge Date
    Beskrivning

    Methacholine Challenge Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0748133
    UMLS CUI [1,3]
    C0430567
    Inhaled Substance
    Beskrivning

    Inhaled Substance

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0205535
    UMLS CUI [1,2]
    C0600370
    UMLS CUI [2,1]
    C0205535
    UMLS CUI [2,2]
    C0036082
    Challenge Concentration (New Subjects)
    Beskrivning

    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.

    Datatyp

    text

    Måttenheter
    • mg/mL
    Alias
    UMLS CUI [1,1]
    C1446561
    UMLS CUI [1,2]
    C0600370
    Challenge Concentration (Historical concentration)
    Beskrivning

    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.

    Datatyp

    float

    Måttenheter
    • mg/mL
    Alias
    UMLS CUI [1,1]
    C1446561
    UMLS CUI [1,2]
    C0600370
    mg/mL
    Start Time of Inhalation
    Beskrivning

    Fill in only for saline inhalation and new subjects.

    Datatyp

    time

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

    Stop Time of Inhalation

    Datatyp

    time

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

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

    Datatyp

    text

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

    Pulmonary function time

    Datatyp

    time

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

    FEV1 Result

    Datatyp

    float

    Måttenheter
    • L
    Alias
    UMLS CUI [1,1]
    C0429706
    UMLS CUI [1,2]
    C0430567
    L
    Pulmonary function tests: Post-Methacholine Challenge
    Beskrivning

    Pulmonary function tests: Post-Methacholine Challenge

    Alias
    UMLS CUI-1
    C0231921
    UMLS CUI-2
    C0430567
    UMLS CUI-3
    C0439568
    Date of post-challenge FEV1
    Beskrivning

    Date of post-challenge FEV1

    Datatyp

    date

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

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

    Datatyp

    time

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

    Record use of rescue Salbutamol on the Concomitant Medications page.

    Datatyp

    float

    Måttenheter
    • L
    Alias
    UMLS CUI [1,1]
    C0429706
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C0439568
    L
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    Similar models

    Lung function testing - Treatment Period 1, Day 29

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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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