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ID

32961

Beschrijving

Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the physical examination form. It has to be filled in for screening and for periods 1-5.

Trefwoorden

  1. 16-11-18 16-11-18 -
  2. 22-11-18 22-11-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

22 november 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877

    Physical examination

    1. StudyEvent: ODM
      1. Physical examination
    Administrative data
    Beschrijving

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Beschrijving

    Subject number

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585
    Treatment Period/Session number
    Beschrijving

    Treatment Period/Session number

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C1948053
    Physical Examination
    Beschrijving

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Physical Examination
    Beschrijving

    Physical Examination, Systems

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0031809
    Examination status
    Beschrijving

    "Not done" only applicable for: Breasts, Urogenital, Pelvic and Rectal.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0449438
    If abnormal examination, please specify
    Beschrijving

    Abnormal examination

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0459424

    Similar models

    Physical examination

    1. StudyEvent: ODM
      1. Physical examination
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Item
    Treatment Period/Session number
    integer
    C0237753 (UMLS CUI [1,1])
    C1948053 (UMLS CUI [1,2])
    Code List
    Treatment Period/Session number
    CL Item
    Screening (1)
    CL Item
    Treatment Period 1 (2)
    CL Item
    Treatment Period 2 (3)
    CL Item
    Treatment Period 3 (4)
    CL Item
    Treatment Period 4 (5)
    CL Item
    Treatment Period 5 (6)
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Item
    Physical Examination
    integer
    C0031809 (UMLS CUI [1])
    Code List
    Physical Examination
    CL Item
    Hair and Skin  (1)
    CL Item
    Lymph nodes  (2)
    CL Item
    Eyes  (3)
    CL Item
    Ears, Nose and Throat  (4)
    CL Item
    Breasts  (5)
    CL Item
    Respiratory (6)
    CL Item
    Cardiovascular  (7)
    CL Item
    Abdomen (8)
    CL Item
    Uro genital  (9)
    CL Item
    Pelvic  (10)
    CL Item
    Rectal  (11)
    CL Item
    M usculoskeletal (12)
    CL Item
    Neurological  (13)
    CL Item
    Mental Status (14)
    Item
    Examination status
    text
    C0031809 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Code List
    Examination status
    CL Item
    Normal (N)
    CL Item
    Abnormal (AN)
    CL Item
    Not Done (ND)
    Abnormal examination
    Item
    If abnormal examination, please specify
    text
    C0031809 (UMLS CUI [1,1])
    C0459424 (UMLS CUI [1,2])

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