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ID

32826

Description

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.

Mots-clés

  1. 16/11/2018 16/11/2018 -
  2. 22/11/2018 22/11/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

16 novembre 2018

DOI

Pour une demande vous connecter.

Licence

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
    Description

    Administrative data

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

    Subject number

    Type de données

    text

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

    Period/Session number

    Type de données

    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
    Description

    Physical Examination

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

    Physical Examination, Systems

    Type de données

    integer

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

    "Not done" referd to: Brests, Urogenital, Pelvic and Rectal.

    Type de données

    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 sepcify
    Description

    Abnormal examination

    Type de données

    text

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

    Similar models

    Physical examination

    1. StudyEvent: ODM
      1. Physical examination
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Item
    Period/Session number
    integer
    C0237753 (UMLS CUI [1,1])
    C1948053 (UMLS CUI [1,2])
    Code List
    Period/Session number
    CL Item
    Screening (0)
    CL Item
    Period 1 (1)
    CL Item
    Period 2 (2)
    CL Item
    Period 3 (3)
    CL Item
    Period 4 (4)
    CL Item
    Period 5 (5)
    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 sepcify
    text
    C0031809 (UMLS CUI [1,1])
    C0459424 (UMLS CUI [1,2])

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