0 Beoordelingen
ID

33004

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

Trefwoorden

Versies (3)
  1. 14-11-18 14-11-18 -
  2. 22-11-18 22-11-18 -
  3. 23-11-18 23-11-18 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

23 november 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

    Geen commentaren

    U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

    Engels

    Vital signs

    1 Formulieren  
    1. StudyEvent: ODM
      1. Vital signs
    Administrative data
    Beschrijving

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Beschrijving

    Subject number

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585
    Session Number
    Beschrijving

    Session Number

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1883017
    UMLS CUI [1,2]
    C0750480
    Vital Signs
    Beschrijving

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Row no.
    Beschrijving

    Row no.

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0237753
    Date of vital signs
    Beschrijving

    Date of vital signs

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0518766
    Planned relative time
    Beschrijving

    Time relative to dosing. Please fill out at least one measurement for screening and one pre-dose measurement for each treatment period. For all additional measurements choose "unscheduled".

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0439564
    Actual time
    Beschrijving

    00:00-23:59

    Datatype

    time

    Alias
    UMLS CUI [1]
    C0040223
    Blood pressure: systolic
    Beschrijving

    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.

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood pressure: diastolic
    Beschrijving

    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.

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Beschrijving

    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.

    Datatype

    integer

    Maateenheden
    • beats / min
    Alias
    UMLS CUI [1]
    C0018810
    beats / min
    Body Temperature
    Beschrijving

    Only for session 2-6.

    Datatype

    integer

    Maateenheden
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Terug naar het begin van de pagina

    Similar models

    Vital signs

    1 Formulieren
    1. StudyEvent: ODM
      1. Vital signs
    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
    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])
    Terug naar het begin van de pagina 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial