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ID

32952

Beschrijving

Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

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Versies (2)
  1. 21-11-18 21-11-18 -
  2. 23-11-18 23-11-18 -
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GlaxoSmithKline

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21 november 2018

DOI

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Creative Commons BY-NC 3.0
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    Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138

    Engels

    Date of Visit/ Assessment, Vital signs, Candidiasis Examination, Inhaler Ease Of Use Assessment,Device Use Assessment, Subject Withdrawal Status, Electronically transferred lab data, Liver Events Assessment - Visit 5

    1 Formulieren  
    Date of Visit/ Assessment
    Beschrijving

    Date of Visit/ Assessment

    Alias
    UMLS CUI-1
    C1320303
    UMLS CUI-2
    C2985720
    Date of Visit/ Assessment
    Beschrijving

    Date of Visit/ Assessment

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Vital signs
    Beschrijving

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Actual date/ time
    Beschrijving

    Actual date/ time

    Datatype

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    Blood pressure (systolic/ diastolic)
    Beschrijving

    Blood pressure

    Datatype

    text

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Subject position
    Beschrijving

    Position must be consistent throughout the study.

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1262869
    Heart rate
    Beschrijving

    Heart rate

    Datatype

    integer

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

    Temperature

    Datatype

    float

    Maateenheden
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Respiration rate
    Beschrijving

    Respiration rate

    Datatype

    integer

    Maateenheden
    • breaths/min
    Alias
    UMLS CUI [1]
    C0231832
    breaths/min
    Calculated Subject position
    Beschrijving

    Calculated Subject position

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1262869
    UMLS CUI [1,2]
    C0444686
    Candidiasis Examination
    Beschrijving

    Candidiasis Examination

    Alias
    UMLS CUI-1
    C0006840
    UMLS CUI-2
    C4321457
    Does the subject have clinical visual evidence of oropharyngeal candidiasis?
    Beschrijving

    Oropharyngeal candidiasis

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0919659
    Inhaler Ease Of Use Assessment
    Beschrijving

    Inhaler Ease Of Use Assessment

    Alias
    UMLS CUI-1
    C1272700
    UMLS CUI-2
    C0021461
    UMLS CUI-3
    C1524063
    UMLS CUI-4
    C0220825
    How do you rate the ease of use of the inhaler?
    Beschrijving

    Ease of use of the inhaler

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1272700
    UMLS CUI [1,2]
    C0021461
    UMLS CUI [1,3]
    C1524063
    How easily are you able to tell how many doses of medication are left in the inhaler?
    Beschrijving

    How easily are you able to tell how many doses of medication are left in the inhaler?

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1272700
    UMLS CUI [1,2]
    C2364293
    UMLS CUI [2,1]
    C0178602
    UMLS CUI [2,2]
    C0750480
    UMLS CUI [2,3]
    C0021461
    Device Use Assessment
    Beschrijving

    Device Use Assessment

    Alias
    UMLS CUI-1
    C0699733
    UMLS CUI-2
    C1524063
    UMLS CUI-3
    C0220825
    Did the subject use the device correctly?
    Beschrijving

    Did the subject use the device correctly?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0699733
    UMLS CUI [1,2]
    C1524063
    UMLS CUI [1,3]
    C2349182
    If subject does not use the device correctly, what did subject do incorrectly? ´
    Beschrijving

    If subject does not use the device correctly, what did subject do incorrectly?

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C3544346
    If subject does not use the device correctly, record number of times subject required additional instruction.
    Beschrijving

    Number of times subject required additional instruction

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C3544346
    UMLS CUI [2,1]
    C1442085
    UMLS CUI [2,2]
    C1524062
    UMLS CUI [2,3]
    C0237753
    Subject Withdrawal Status
    Beschrijving

    Subject Withdrawal Status

    Alias
    UMLS CUI-1
    C0422727
    UMLS CUI-2
    C0449438
    Did the subject withdraw at this visit?
    Beschrijving

    Did the subject withdraw at this visit?

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1710677
    UMLS CUI [2]
    C0545082
    Electronically transferred lab data
    Beschrijving

    Electronically transferred lab data

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C1320722
    Date Sample(s) Taken
    Beschrijving

    Date Sample(s) Taken

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1302413
    Haem Lab type code
    Beschrijving

    Haem Lab type code

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0022877
    UMLS CUI [1,3]
    C0805701
    Chem Lab type code
    Beschrijving

    Chem Lab type code

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0005774
    UMLS CUI [1,2]
    C0022877
    UMLS CUI [1,3]
    C0805701
    Urin Lab type code
    Beschrijving

    Urin Lab type code

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0022877
    UMLS CUI [1,3]
    C0805701
    Liver Events Assessment
    Beschrijving

    Liver Events Assessment

    Alias
    UMLS CUI-1
    C0023884
    UMLS CUI-2
    C0877248
    UMLS CUI-3
    C0220825
    Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
    Beschrijving

    Liver chemistry event for the lab samples collected at this visit

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [2,1]
    C0005834
    UMLS CUI [2,2]
    C0545082
    Specify type of liver chemistry event.
    Beschrijving

    Specify type of liver chemistry event

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C2348235
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    Similar models

    Date of Visit/ Assessment, Vital signs, Candidiasis Examination, Inhaler Ease Of Use Assessment,Device Use Assessment, Subject Withdrawal Status, Electronically transferred lab data, Liver Events Assessment - Visit 5

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Date of Visit/ Assessment
    C1320303 (UMLS CUI-1)
    C2985720 (UMLS CUI-2)
    Date of Visit/ Assessment
    Item
    Date of Visit/ Assessment
    date
    C1320303 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Actual date/ time
    Item
    Actual date/ time
    datetime
    C1264639 (UMLS CUI [1])
    Blood pressure
    Item
    Blood pressure (systolic/ diastolic)
    text
    C0005823 (UMLS CUI [1])
    Item
    Subject position
    integer
    C1262869 (UMLS CUI [1])
    Subject position
    Code List
    Subject position
    CL Item
    Supine  (1)
    CL Item
    Sitting  (2)
    CL Item
    Standing  (3)
    CL Item
    Semi- supine (4)
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Respiration rate
    Item
    Respiration rate
    integer
    C0231832 (UMLS CUI [1])
    Calculated Subject position
    Item
    Calculated Subject position
    text
    C1262869 (UMLS CUI [1,1])
    C0444686 (UMLS CUI [1,2])
    Item Group
    Candidiasis Examination
    C0006840 (UMLS CUI-1)
    C4321457 (UMLS CUI-2)
    Oropharyngeal candidiasis
    Item
    Does the subject have clinical visual evidence of oropharyngeal candidiasis?
    boolean
    C0919659 (UMLS CUI [1])
    Item Group
    Inhaler Ease Of Use Assessment
    C1272700 (UMLS CUI-1)
    C0021461 (UMLS CUI-2)
    C1524063 (UMLS CUI-3)
    C0220825 (UMLS CUI-4)
    Item
    How do you rate the ease of use of the inhaler?
    integer
    C1272700 (UMLS CUI [1,1])
    C0021461 (UMLS CUI [1,2])
    C1524063 (UMLS CUI [1,3])
    ease of use of the inhaler
    Code List
    How do you rate the ease of use of the inhaler?
    CL Item
    Very easy (1)
    CL Item
    Easy (2)
    CL Item
    Neutral (3)
    CL Item
    Difficult (4)
    CL Item
    Very Difficult (5)
    Item
    How easily are you able to tell how many doses of medication are left in the inhaler?
    integer
    C1272700 (UMLS CUI [1,1])
    C2364293 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [2,1])
    C0750480 (UMLS CUI [2,2])
    C0021461 (UMLS CUI [2,3])
    undefined item
    Code List
    How easily are you able to tell how many doses of medication are left in the inhaler?
    CL Item
    Very easy (1)
    CL Item
    Easy (2)
    CL Item
    Neutral (3)
    CL Item
    Difficult (4)
    CL Item
    Very difficult (5)
    Item Group
    Device Use Assessment
    C0699733 (UMLS CUI-1)
    C1524063 (UMLS CUI-2)
    C0220825 (UMLS CUI-3)
    Did the subject use the device correctly?
    Item
    Did the subject use the device correctly?
    boolean
    C0699733 (UMLS CUI [1,1])
    C1524063 (UMLS CUI [1,2])
    C2349182 (UMLS CUI [1,3])
    Item
    If subject does not use the device correctly, what did subject do incorrectly? ´
    integer
    C3544346 (UMLS CUI [1])
    If subject does not use the device correctly, what did subject do incorrectly?
    Code List
    If subject does not use the device correctly, what did subject do incorrectly? ´
    CL Item
    Open the device  (1)
    CL Item
    Inhale the device (2)
    CL Item
    Close the device (3)
    Item
    If subject does not use the device correctly, record number of times subject required additional instruction.
    integer
    C3544346 (UMLS CUI [1])
    C1442085 (UMLS CUI [2,1])
    C1524062 (UMLS CUI [2,2])
    C0237753 (UMLS CUI [2,3])
    Number of times subject required additional instruction
    Code List
    If subject does not use the device correctly, record number of times subject required additional instruction.
    CL Item
    1  (1)
    CL Item
    2  (2)
    CL Item
    3  (3)
    CL Item
    >3 (4)
    Item Group
    Subject Withdrawal Status
    C0422727 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    Did the subject withdraw at this visit?
    Item
    Did the subject withdraw at this visit?
    boolean
    C1710677 (UMLS CUI [1])
    C0545082 (UMLS CUI [2])
    Item Group
    Electronically transferred lab data
    C0022885 (UMLS CUI-1)
    C1320722 (UMLS CUI-2)
    Date Sample(s) Taken
    Item
    Date Sample(s) Taken
    date
    C1302413 (UMLS CUI [1])
    Haem Lab type code
    Item
    Haem Lab type code
    text
    C0018941 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    C0805701 (UMLS CUI [1,3])
    Chem Lab type code
    Item
    Chem Lab type code
    text
    C0005774 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    C0805701 (UMLS CUI [1,3])
    Urin Lab type code
    Item
    Urin Lab type code
    text
    C0042014 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    C0805701 (UMLS CUI [1,3])
    Item Group
    Liver Events Assessment
    C0023884 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    C0220825 (UMLS CUI-3)
    Liver chemistry event for the lab samples collected at this visit
    Item
    Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
    boolean
    C0008000 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C0005834 (UMLS CUI [2,1])
    C0545082 (UMLS CUI [2,2])
    Item
    Specify type of liver chemistry event.
    integer
    C0008000 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Specify type of liver chemistry event
    Code List
    Specify type of liver chemistry event.
    CL Item
    Liver Event Monitoring Criteria (subject has met protocol defined liver event monitoring criteria). Obtain tests as per protocol. (1)
    CL Item
    Liver Event Stopping Criteria (subject has met protocol defined liver event stopping criteria, has been monitored for the protocol specified time period and continues to meet liver chemistry monitoring criteria). Stop investigational product, complete date stopped on Investigational Product Form and contact GSK within 24 hours of occurence of liver event by phone or fax. NOTE: If the liver event meets the definition of an SAE, the SAE form must be completed in InForm. If InForm is unavailable, the SAE form should be faxed to GSK. (2)
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