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ID

33020

Description

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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Versions (1)
  1. 2018-11-23 2018-11-23 -
Copyright Holder

GlaxoSmithKline

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23 november 2018

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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

    English

    Date of Visit/ Assessment, Completion of Visit Assessments (Follow- Up); Date of Visit/ Assessment, Vital signs, Candidiasis Examination, Electronically transferred lab data, Liver Events Assessment (Early Withdrawal)

    1 forms  
    Date of Visit/ Assessment - Follow- Up
    Description

    Date of Visit/ Assessment - Follow- Up

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

    Date of Visit/ Assessment

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Completion of Visit Assessments
    Description

    Completion of Visit Assessments

    Alias
    UMLS CUI-1
    C0545082
    UMLS CUI-2
    C0220825
    UMLS CUI-3
    C0205197
    Were all Follow- up Visit assessments completed as per the protocol?
    Description

    Follow- up Visit assessments completed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0589121
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [1,3]
    C0205197
    UMLS CUI [2]
    C2348563
    Date of Visit/ Assessment - Early Withdrawal
    Description

    Date of Visit/ Assessment - Early Withdrawal

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

    Date of Visit/ Assessment

    Data type

    date

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

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Actual date/ time
    Description

    Actual date/ time

    Data type

    datetime

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

    Blood pressure

    Data type

    text

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Subject position
    Description

    Position must be consistent throughout the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1262869
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Respiration rate
    Description

    Respiration rate

    Data type

    integer

    Measurement units
    • breaths/min
    Alias
    UMLS CUI [1]
    C0231832
    breaths/min
    Calculated Subject position
    Description

    Calculated Subject position

    Data type

    text

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

    Candidiasis Examination

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

    Oropharyngeal candidiasis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0919659
    Electronically transferred lab data
    Description

    Electronically transferred lab data

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

    Date Sample(s) Taken

    Data type

    date

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

    Haem Lab type code

    Data type

    text

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

    Chem Lab type code

    Data type

    text

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

    Urin Lab type code

    Data type

    text

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

    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?
    Description

    Liver chemistry event for the lab samples collected at this visit

    Data type

    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.
    Description

    Specify type of liver chemistry event

    Data type

    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, Completion of Visit Assessments (Follow- Up); Date of Visit/ Assessment, Vital signs, Candidiasis Examination, Electronically transferred lab data, Liver Events Assessment (Early Withdrawal)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Date of Visit/ Assessment - Follow- Up
    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
    Completion of Visit Assessments
    C0545082 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    C0205197 (UMLS CUI-3)
    Follow- up Visit assessments completed
    Item
    Were all Follow- up Visit assessments completed as per the protocol?
    boolean
    C0589121 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C0205197 (UMLS CUI [1,3])
    C2348563 (UMLS CUI [2])
    Item Group
    Date of Visit/ Assessment - Early Withdrawal
    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
    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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