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ID

32756

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 vital signs form. It has to be filled in at screnning, for session 2, 3,4, 5 and 6.

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Versions (3)
  1. 14/11/2018 14/11/2018 -
  2. 22/11/2018 22/11/2018 -
  3. 23/11/2018 23/11/2018 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

14 de novembro de 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

    English

    Vital signs

    1 forms  
    1. StudyEvent: ODM
      1. Vital signs
    Administrative data
    Description

    Administrative data

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

    Subject number

    Data type

    text

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

    Session Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1883017 (Session)
    UMLS CUI [1,2]
    C0750480 (Count)
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Row no.
    Description

    Row no.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Date of vital signs
    Description

    Date of vital signs

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Planned relative time
    Description

    Time relative to dosing. For screening (session 1) measurement is mandatory.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    Actual time
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Blood pressure: systolic
    Description

    NOTE: HR and BP measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Blood pressure: diastolic
    Description

    NOTE: HR and BP measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mmHg
    Heart rate
    Description

    NOTE: HR and BP measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.

    Data type

    integer

    Measurement units
    • beats / min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats / min
    Body Temperature
    Description

    Only for session 2-6.

    Data type

    integer

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903 (Body Temperature)
    SNOMED
    722490005
    LOINC
    LP36617-6
    °C
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    Similar models

    Vital signs

    1 forms
    1. StudyEvent: ODM
      1. Vital signs
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Item
    Session Number
    integer
    C1883017 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    Session Number
    Code List
    Session Number
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Item
    Row no.
    integer
    C0237753 (UMLS CUI [1])
    Row no.
    Code List
    Row no.
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    Date of vital signs
    Item
    Date of vital signs
    date
    C0011008 (UMLS CUI [1,1])
    C0518766 (UMLS CUI [1,2])
    Item
    Planned relative time
    text
    C0439564 (UMLS CUI [1])
    Planned relative time
    Code List
    Planned relative time
    CL Item
    Screening (S)
    CL Item
    Pre dose (P)
    CL Item
    Unscheduled (U)
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Blood pressure: systolic
    Item
    Blood pressure: systolic
    integer
    C0871470 (UMLS CUI [1])
    Blood pressure: diastolic
    Item
    Blood pressure: diastolic
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Body Temperature
    Item
    Body Temperature
    integer
    C0005903 (UMLS CUI [1])
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