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ID

29668

Beschreibung

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. Time: Treatment Period 2, Day 28.

Link

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

Stichworte

Versionen (1)
  1. 10.04.18 10.04.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. April 2018

DOI

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Lizenz

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

    Englisch

    Lung function testing - Treatment Period 2, Day 28

    1 Formulare  
    Exhaled nitric oxide
    Beschreibung

    Exhaled nitric oxide

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

    e.g., 08 JAN 04

    Datentyp

    date

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

    Time relative to dosing

    Datentyp

    text

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

    hr:min 00:00 - 23:59

    Datentyp

    time

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

    e.g., 50.7

    Datentyp

    float

    Maßeinheiten
    • 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
    Beschreibung

    e.g., 51.0

    Datentyp

    float

    Maßeinheiten
    • 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
    Beschreibung

    e.g., 51.3

    Datentyp

    float

    Maßeinheiten
    • 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
    Beschreibung

    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
    Beschreibung

    Date of FEV1

    Datentyp

    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
    Beschreibung

    Time relative to Dosing.

    Datentyp

    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
    Beschreibung

    Hr : Min 00:00-23:59

    Datentyp

    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
    Beschreibung

    Reading 1 of FEV1

    Datentyp

    float

    Maßeinheiten
    • 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
    Beschreibung

    Reading 2 of FEV1

    Datentyp

    float

    Maßeinheiten
    • 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
    Beschreibung

    Reading 3 of FEV1

    Datentyp

    float

    Maßeinheiten
    • 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
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    Ähnliche Modelle

    Lung function testing - Treatment Period 2, Day 28

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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
    pre-dose (pre-dose)
    (Comment:en)
    CL Item
    unscheduled (unscheduled)
    (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
    pre-dose (pre-dose)
    CL Item
    post-dose (discharge) (post-dose (discharge))
    CL Item
    unscheduled (unscheduled)
    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])
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