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32961

Beschreibung

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.

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  1. 16.11.18 16.11.18 -
  2. 22.11.18 22.11.18 -
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GlaxoSmithKline

Hochgeladen am

22. November 2018

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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

    Englisch

    Physical examination

    1 Formulare  
    1. StudyEvent: ODM
      1. Physical examination
    Administrative data
    Beschreibung

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject number
    Beschreibung

    Subject number

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Treatment Period/Session number
    Beschreibung

    Treatment Period/Session number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    UMLS CUI [1,2]
    C1948053 (Period (temporal qualifier))
    SNOMED
    272117007
    Physical Examination
    Beschreibung

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Physical Examination
    Beschreibung

    Physical Examination, Systems

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Examination status
    Beschreibung

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

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    If abnormal examination, please specify
    Beschreibung

    Abnormal examination

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0459424 (Abnormal result)
    SNOMED
    280415008
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    Ähnliche Modelle

    Physical examination

    1 Formulare
    1. StudyEvent: ODM
      1. Physical examination
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    Period/Session number
    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])
    Physical Examination, Systems
    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])
    Examination status
    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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