0 Ratings
ID

32965

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 medical history and state of training of subject. It has to be filled in at screening.

Keywords

Versions (3)
  1. 11/13/18 11/13/18 -
  2. 11/16/18 11/16/18 -
  3. 11/22/18 11/22/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 22, 2018

DOI

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License

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

    Medical history and training

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Description

    Subject number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of screening
    Description

    Date of screening

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1710477
    Medical History
    Description

    Medical History

    Alias
    UMLS CUI-1
    C0262926
    Medical conditions
    Description

    Medical history, examinaton

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0012634
    Medical condition status
    Description

    Medical condition status

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0449438
    If you tick yes in "medical condition status", please specify
    Description

    Medical condition, present

    Data type

    text

    Alias
    UMLS CUI [1]
    C0012634
    Training
    Description

    Training

    Alias
    UMLS CUI-1
    C0015259
    Has the subject had DISKUS/ACCUHALER training, MDI training and spacer training?
    Description

    Accuhaler, MDI, spacer training

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0939246
    UMLS CUI [1,2]
    C0015259
    UMLS CUI [2,1]
    C0993596
    UMLS CUI [2,2]
    C0015259
    UMLS CUI [3,1]
    C0592626
    UMLS CUI [3,2]
    C0015259
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    Similar models

    Medical history and training

    1 forms
    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])
    Date of screening
    Item
    Date of screening
    date
    C0011008 (UMLS CUI [1,1])
    C1710477 (UMLS CUI [1,2])
    Item Group
    Medical History
    C0262926 (UMLS CUI-1)
    Item
    Medical conditions
    integer
    C0012634 (UMLS CUI [1])
    Ear, Nose and Throat
    Code List
    Medical conditions
    CL Item
    Ear, Nose and Throat  (1)
    CL Item
    Eyes  (2)
    CL Item
    Respiratory (3)
    CL Item
    Cardiovascular (4)
    CL Item
    Gastrointestinal  (5)
    CL Item
    Hepatobiliary and pancreas (6)
    CL Item
    Urology (7)
    CL Item
    Reproduction (8)
    CL Item
    Neurology  (9)
    CL Item
    Blood and lymphatic (10)
    CL Item
    Endocrine and metabolic (11)
    CL Item
    Musculoskeletal (12)
    CL Item
    Skin  (13)
    CL Item
    Psychiatry  (14)
    CL Item
    Allergies (15)
    Item
    Medical condition status
    text
    C0012634 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Ear, Nose and Throat
    Code List
    Medical condition status
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Medical condition, present
    Item
    If you tick yes in "medical condition status", please specify
    text
    C0012634 (UMLS CUI [1])
    Item Group
    Training
    C0015259 (UMLS CUI-1)
    Item
    Has the subject had DISKUS/ACCUHALER training, MDI training and spacer training?
    text
    C0939246 (UMLS CUI [1,1])
    C0015259 (UMLS CUI [1,2])
    C0993596 (UMLS CUI [2,1])
    C0015259 (UMLS CUI [2,2])
    C0592626 (UMLS CUI [3,1])
    C0015259 (UMLS CUI [3,2])
    Accuhaler, MDI, spacer training
    Code List
    Has the subject had DISKUS/ACCUHALER training, MDI training and spacer training?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Back to the top of the page 

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