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ID

32719

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

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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

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November 13, 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

    Medical history, training and physical examination

    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
    Ear, Nose and Throat
    Description

    Ear, Nose and Throat

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013443
    UMLS CUI [1,2]
    C0028429
    UMLS CUI [1,3]
    C0031354
    Eyes
    Description

    Eyes

    Data type

    text

    Alias
    UMLS CUI [1]
    C0015392
    Respiratory
    Description

    Respiratory

    Data type

    text

    Alias
    UMLS CUI [1]
    C0035237
    Cardiovascular
    Description

    Cardiovascular

    Data type

    text

    Alias
    UMLS CUI [1]
    C0007226
    Gastrointestinal
    Description

    Gastrointestinal

    Data type

    text

    Alias
    UMLS CUI [1]
    C0017189
    Hepatobiliary and pancreas
    Description

    Hepatobiliary and pancreas

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1711359
    UMLS CUI [1,2]
    C0030274
    Urology
    Description

    Urology

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042077
    Reproduction
    Description

    Reproduction

    Data type

    text

    Alias
    UMLS CUI [1]
    C0035150
    Neurology
    Description

    Neurology

    Data type

    text

    Alias
    UMLS CUI [1]
    C0027763
    Blood and lymphatic
    Description

    Blood and lymphatic

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0279810
    UMLS CUI [1,2]
    C0024235
    Endocrine and metabolic
    Description

    Endocrine and metabolic

    Data type

    text

    Alias
    UMLS CUI [1]
    C3841737
    Musculoskeletal
    Description

    Musculoskeletal

    Data type

    text

    Alias
    UMLS CUI [1]
    C0026860
    Skin
    Description

    Skin

    Data type

    text

    Alias
    UMLS CUI [1]
    C1123023
    Psychiatry
    Description

    Psychiatry

    Data type

    text

    Alias
    UMLS CUI [1]
    C0278060
    Allergies
    Description

    Allergies

    Data type

    text

    Alias
    UMLS CUI [1]
    C0020517
    If a box above is ticked, describe concisely for each.
    Description

    Description of medical history

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0678257
    UMLS CUI [1,2]
    C0262926
    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
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Hair and Skin
    Description

    Hair and Skin

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0018494
    UMLS CUI [1,2]
    C0558035
    Lymph nodes
    Description

    Lymph nodes

    Data type

    text

    Alias
    UMLS CUI [1]
    C0024204
    Eyes
    Description

    Eyes

    Data type

    text

    Alias
    UMLS CUI [1]
    C0015392
    Ear, Nose and Throat
    Description

    Ear, Nose and Throat

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013443
    UMLS CUI [1,2]
    C0028429
    UMLS CUI [1,3]
    C0031354
    Breasts
    Description

    Breasts

    Data type

    text

    Alias
    UMLS CUI [1]
    C0199850
    Respiratory
    Description

    Respiratory

    Data type

    text

    Alias
    UMLS CUI [1]
    C0035237
    Cardiovascular
    Description

    Cardiovascular

    Data type

    text

    Alias
    UMLS CUI [1]
    C0007226
    Abdomen
    Description

    Abdomen

    Data type

    text

    Alias
    UMLS CUI [1]
    C0000726
    Urogenital
    Description

    Urogenital

    Data type

    text

    Alias
    UMLS CUI [1]
    C1828035
    Pelvic
    Description

    Pelvic

    Data type

    text

    Alias
    UMLS CUI [1]
    C0030797
    Rectal
    Description

    Rectal

    Data type

    text

    Alias
    UMLS CUI [1]
    C0199900
    Musculoskeletal
    Description

    Musculoskeletal

    Data type

    text

    Alias
    UMLS CUI [1]
    C0026860
    Neurological
    Description

    Neurological

    Data type

    text

    Alias
    UMLS CUI [1]
    C0027853
    Mental Status
    Description

    Mental Status

    Data type

    text

    Alias
    UMLS CUI [1]
    C0278060
    If a box above is ticked, describe concisely for each.
    Description

    Description of physical examination

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0678257
    UMLS CUI [1,2]
    C0031809
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    Similar models

    Medical history, training and physical examination

    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
    Ear, Nose and Throat
    text
    C0013443 (UMLS CUI [1,1])
    C0028429 (UMLS CUI [1,2])
    C0031354 (UMLS CUI [1,3])
    Ear, Nose and Throat
    Code List
    Ear, Nose and Throat
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Eyes
    text
    C0015392 (UMLS CUI [1])
    Ear, Nose and Throat
    Code List
    Eyes
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Respiratory
    text
    C0035237 (UMLS CUI [1])
    Ear, Nose and Throat
    Code List
    Respiratory
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Cardiovascular
    text
    C0007226 (UMLS CUI [1])
    Ear, Nose and Throat
    Code List
    Cardiovascular
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Gastrointestinal
    text
    C0017189 (UMLS CUI [1])
    Ear, Nose and Throat
    Code List
    Gastrointestinal
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Hepatobiliary and pancreas
    text
    C1711359 (UMLS CUI [1,1])
    C0030274 (UMLS CUI [1,2])
    Hepatobiliary and pancreas
    Code List
    Hepatobiliary and pancreas
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Urology
    text
    C0042077 (UMLS CUI [1])
    Urology
    Code List
    Urology
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Reproduction
    text
    C0035150 (UMLS CUI [1])
    Urology
    Code List
    Reproduction
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Neurology
    text
    C0027763 (UMLS CUI [1])
    Urology
    Code List
    Neurology
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Blood and lymphatic
    text
    C0279810 (UMLS CUI [1,1])
    C0024235 (UMLS CUI [1,2])
    Urology
    Code List
    Blood and lymphatic
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Endocrine and metabolic
    text
    C3841737 (UMLS CUI [1])
    Urology
    Code List
    Endocrine and metabolic
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Musculoskeletal
    text
    C0026860 (UMLS CUI [1])
    Urology
    Code List
    Musculoskeletal
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Skin
    text
    C1123023 (UMLS CUI [1])
    Urology
    Code List
    Skin
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Psychiatry
    text
    C0278060 (UMLS CUI [1])
    Urology
    Code List
    Psychiatry
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Allergies
    text
    C0020517 (UMLS CUI [1])
    Urology
    Code List
    Allergies
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Description of medical history
    Item
    If a box above is ticked, describe concisely for each.
    text
    C0678257 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    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)
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Item
    Hair and Skin
    text
    C0018494 (UMLS CUI [1,1])
    C0558035 (UMLS CUI [1,2])
    Ear, Nose and Throat
    Code List
    Hair and Skin
    CL Item
    Normal (N)
    CL Item
    Abnormal (AN)
    Item
    Lymph nodes
    text
    C0024204 (UMLS CUI [1])
    Ear, Nose and Throat
    Code List
    Lymph nodes
    CL Item
    Normal (N)
    CL Item
    Abnormal (AN)
    Item
    Eyes
    text
    C0015392 (UMLS CUI [1])
    Ear, Nose and Throat
    Code List
    Eyes
    CL Item
    Normal (N)
    CL Item
    Abnormal (AN)
    Item
    Ear, Nose and Throat
    text
    C0013443 (UMLS CUI [1,1])
    C0028429 (UMLS CUI [1,2])
    C0031354 (UMLS CUI [1,3])
    Ear, Nose and Throat
    Code List
    Ear, Nose and Throat
    CL Item
    Normal (N)
    CL Item
    Abnormal (AN)
    Item
    Breasts
    text
    C0199850 (UMLS CUI [1])
    Ear, Nose and Throat
    Code List
    Breasts
    CL Item
    Normal (N)
    CL Item
    Abnormal (AN)
    CL Item
    Not Done (ND)
    Item
    Respiratory
    text
    C0035237 (UMLS CUI [1])
    Ear, Nose and Throat
    Code List
    Respiratory
    CL Item
    Normal (N)
    CL Item
    Abnormal (AN)
    Item
    Cardiovascular
    text
    C0007226 (UMLS CUI [1])
    Ear, Nose and Throat
    Code List
    Cardiovascular
    CL Item
    Normal (N)
    CL Item
    Abnormal (AN)
    Item
    Abdomen
    text
    C0000726 (UMLS CUI [1])
    Ear, Nose and Throat
    Code List
    Abdomen
    CL Item
    Normal (N)
    CL Item
    Abnormal (AN)
    Item
    Urogenital
    text
    C1828035 (UMLS CUI [1])
    Ear, Nose and Throat
    Code List
    Urogenital
    CL Item
    Normal (N)
    CL Item
    Abnormal (AN)
    CL Item
    Not Done (ND)
    Item
    Pelvic
    text
    C0030797 (UMLS CUI [1])
    Ear, Nose and Throat
    Code List
    Pelvic
    CL Item
    Normal (N)
    CL Item
    Abnormal (AN)
    CL Item
    Not Done (ND)
    Item
    Rectal
    text
    C0199900 (UMLS CUI [1])
    Urology
    Code List
    Rectal
    CL Item
    Normal (N)
    CL Item
    Abnormal (AN)
    CL Item
    Not Done (ND)
    Item
    Musculoskeletal
    text
    C0026860 (UMLS CUI [1])
    Urology
    Code List
    Musculoskeletal
    CL Item
    Normal (N)
    CL Item
    Abnormal (AN)
    Item
    Neurological
    text
    C0027853 (UMLS CUI [1])
    Urology
    Code List
    Neurological
    CL Item
    Normal (N)
    CL Item
    Abnormal (AN)
    Item
    Mental Status
    text
    C0278060 (UMLS CUI [1])
    Urology
    Code List
    Mental Status
    CL Item
    Normal (N)
    CL Item
    Abnormal (AN)
    Description of physical examination
    Item
    If a box above is ticked, describe concisely for each.
    text
    C0678257 (UMLS CUI [1,1])
    C0031809 (UMLS CUI [1,2])
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