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ID

32951

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 (2)
  1. 11/21/18 11/21/18 -
  2. 11/23/18 11/23/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 21, 2018

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License

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, Vital signs, Candidiasis Examination, Device Use Assessment, Subject Withdrawal Status, Electronically transferred lab data, Liver Events Assessment - Visit 4

    1 forms  
    Date of Visit/ Assessment
    Description

    Date of Visit/ Assessment

    Alias
    UMLS CUI-1
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI-2
    C2985720 (Assessment Date)
    Date of Visit/ Assessment
    Description

    Date of Visit/ Assessment

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI [1,2]
    C2985720 (Assessment Date)
    Vital signs
    Description

    Vital signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Actual date/ time
    Description

    Actual date/ time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C1264639 (Date/Time)
    SNOMED
    118575009
    Blood pressure (systolic/ diastolic)
    Description

    Blood pressure

    Data type

    text

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    mmHg
    Subject position
    Description

    Position must be consistent throughout the study.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1262869 (Body position)
    SNOMED
    397155001
    LOINC
    LP120681-4
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min
    Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903 (Body Temperature)
    SNOMED
    722490005
    LOINC
    LP36617-6
    °C
    Respiration rate
    Description

    Respiration rate

    Data type

    integer

    Measurement units
    • breaths/min
    Alias
    UMLS CUI [1]
    C0231832 (Respiratory rate)
    SNOMED
    86290005
    LOINC
    LP20159-7
    breaths/min
    Calculated Subject position
    Description

    Calculated Subject position

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1262869 (Body position)
    SNOMED
    397155001
    LOINC
    LP120681-4
    UMLS CUI [1,2]
    C0444686 (Calculated)
    SNOMED
    258090004
    LOINC
    LP99293-0
    Candidiasis Examination
    Description

    Candidiasis Examination

    Alias
    UMLS CUI-1
    C0006840 (Candidiasis)
    SNOMED
    78048006
    UMLS CUI-2
    C4321457 (Examination)
    Does the subject have clinical visual evidence of oropharyngeal candidiasis?
    Description

    Oropharyngeal candidiasis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0919659 (Oropharyngeal candidiasis)
    Device Use Assessment
    Description

    Device Use Assessment

    Alias
    UMLS CUI-1
    C0699733 (Devices)
    SNOMED
    49062001
    UMLS CUI-2
    C1524063 (Use of)
    SNOMED
    260676000
    UMLS CUI-3
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    Did the subject use the device correctly?
    Description

    Did the subject use the device correctly?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0699733 (Devices)
    SNOMED
    49062001
    UMLS CUI [1,2]
    C1524063 (Use of)
    SNOMED
    260676000
    UMLS CUI [1,3]
    C2349182 (Correct (qualifier))
    LOINC
    LA9960-1
    If subject does not use the device correctly, what did subject do incorrectly? ´
    Description

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

    Data type

    integer

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

    Number of times subject required additional instruction

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3544346 (Device use error)
    UMLS CUI [2,1]
    C1442085 (Instructions)
    LOINC
    LP6820-7
    UMLS CUI [2,2]
    C1524062 (Additional)
    LOINC
    LP35025-3
    UMLS CUI [2,3]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Subject Withdrawal Status
    Description

    Subject Withdrawal Status

    Alias
    UMLS CUI-1
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI-2
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    Did the subject withdraw at this visit?
    Description

    Did the subject withdraw at this visit?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1710677 (Withdrawal by Subject)
    UMLS CUI [2]
    C0545082 (Visit)
    Electronically transferred lab data
    Description

    Electronically transferred lab data

    Alias
    UMLS CUI-1
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI-2
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Date Sample(s) Taken
    Description

    Date Sample(s) Taken

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Haem Lab type code
    Description

    Haem Lab type code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0018941 (Hematologic Tests)
    SNOMED
    252275004
    UMLS CUI [1,2]
    C0022877 (Laboratory)
    SNOMED
    261904005
    LOINC
    MTHU029808
    UMLS CUI [1,3]
    C0805701 (Code)
    Chem Lab type code
    Description

    Chem Lab type code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005774 (Blood Chemical Analysis)
    SNOMED
    166312007
    UMLS CUI [1,2]
    C0022877 (Laboratory)
    SNOMED
    261904005
    LOINC
    MTHU029808
    UMLS CUI [1,3]
    C0805701 (Code)
    Urin Lab type code
    Description

    Urin Lab type code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042014 (Urinalysis)
    SNOMED
    167217005
    LOINC
    LP32744-2
    UMLS CUI [1,2]
    C0022877 (Laboratory)
    SNOMED
    261904005
    LOINC
    MTHU029808
    UMLS CUI [1,3]
    C0805701 (Code)
    Liver Events Assessment
    Description

    Liver Events Assessment

    Alias
    UMLS CUI-1
    C0023884 (Liver)
    SNOMED
    10200004
    LOINC
    LP29289-3
    UMLS CUI-2
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI-3
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    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 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0023884 (Liver)
    SNOMED
    10200004
    LOINC
    LP29289-3
    UMLS CUI [1,3]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [2,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [2,2]
    C0545082 (Visit)
    Specify type of liver chemistry event.
    Description

    Specify type of liver chemistry event

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0023884 (Liver)
    SNOMED
    10200004
    LOINC
    LP29289-3
    UMLS CUI [1,3]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,4]
    C2348235 (Specification)
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    Similar models

    Date of Visit/ Assessment, Vital signs, Candidiasis Examination, Device Use Assessment, Subject Withdrawal Status, Electronically transferred lab data, Liver Events Assessment - Visit 4

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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
    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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