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ID

33031

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

Keywords

Versions (1)
  1. 11/23/18 11/23/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 23, 2018

DOI

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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, Unscheduled Assessments Performed, Vital signs, Candidiasis Examination, Electronically transferred lab data, Liver Events Assessment (Unscheduled); Date of Visit/ Assessment, Status of Treatment Blind, Pregnancy Information, Pharmacogenetic (PGx) Research Withdrawal of Consent, Study Conclusion, Investigator Signature (End of Study)

    1 forms  
    Date of Visit/ Assessment - Unscheduled
    Description

    Date of Visit/ Assessment - Unscheduled

    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
    Unscheduled Assessments Performed
    Description

    Unscheduled Assessments Performed

    Alias
    UMLS CUI-1
    C0220825
    UMLS CUI-2
    C3854240
    Select any unscheduled assessments that were performed at this visit.
    Description

    Unscheduled assessments that were performed at this visit

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0220825
    UMLS CUI [1,2]
    C3854240
    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
    Date of Visit/ Assessment - End of Study
    Description

    Date of Visit/ Assessment - End of Study

    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
    Status of Treatment Blind
    Description

    Status of Treatment Blind

    Alias
    UMLS CUI-1
    C0749659
    UMLS CUI-2
    C2347038
    Was the treatment blind broken during the study?
    Description

    Was the treatment blind broken during the study?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3897431
    If the treatment blind was broken during the study, complete Date blind broken.
    Description

    Date blind broken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    Reason for treatment blind was broken
    Description

    Reason for treatment blind was broken

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    If other Reason for treatment blind was broken, specify.
    Description

    If other Reason for treatment blind was broken, specify.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Pregnancy Information
    Description

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    Did the subject become pregnant during the study?
    Description

    Did the subject become pregnant during the study?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3828490
    Pharmacogenetic (PGx) Research Withdrawal of Consent
    Description

    Pharmacogenetic (PGx) Research Withdrawal of Consent

    Alias
    UMLS CUI-1
    C2347500
    UMLS CUI-2
    C0021430
    UMLS CUI-3
    C2349954
    Has the subject withdrawn consent for PGx research?
    Description

    Has the subject withdrawn consent for PGx research?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2349954
    Date informed consent withdrawn
    Description

    Date informed consent withdrawn

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2349954
    UMLS CUI [1,3]
    C0009797
    Has a request been made for sample destruction?
    Description

    Has a request been made for sample destruction?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1272683
    If a request has been made for sample destruction, check reason.
    Description

    Reason for request for sample destruction

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1272683
    If other reason for request for sample destruction, specify.
    Description

    If other reason for request for sample destruction, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1272683
    UMLS CUI [1,4]
    C0205394
    UMLS CUI [1,5]
    C2348235
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008976
    Date of subject completion or withdrawal
    Description

    Date of subject completion or withdrawal

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [2]
    C1549507
    Was the subject withdrawn from the study?
    Description

    Was the subject withdrawn from the study?

    Data type

    text

    Alias
    UMLS CUI [1]
    C0422727
    Primary reason for withdrawal
    Description

    Primary reason for withdrawal

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0392360
    Specify investigator discretion
    Description

    Specify investigator discretion

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008961
    UMLS CUI [1,2]
    C0022423
    UMLS CUI [1,3]
    C2348235
    Withdrew consent specification
    Description

    Withdrew consent specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C2348235
    Investigator Signature
    Description

    Investigator Signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator Signature
    Description

    Investigator Siganture

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
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    Similar models

    Date of Visit/ Assessment, Unscheduled Assessments Performed, Vital signs, Candidiasis Examination, Electronically transferred lab data, Liver Events Assessment (Unscheduled); Date of Visit/ Assessment, Status of Treatment Blind, Pregnancy Information, Pharmacogenetic (PGx) Research Withdrawal of Consent, Study Conclusion, Investigator Signature (End of Study)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Date of Visit/ Assessment - Unscheduled
    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
    Unscheduled Assessments Performed
    C0220825 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    Item
    Select any unscheduled assessments that were performed at this visit.
    integer
    C0220825 (UMLS CUI [1,1])
    C3854240 (UMLS CUI [1,2])
    Unscheduled assessments that were performed at this visit
    Code List
    Select any unscheduled assessments that were performed at this visit.
    CL Item
    Vitals (1)
    CL Item
    Lab (2)
    CL Item
    Candidiasis (3)
    CL Item
    Liver events assessment as a result of unscheduled chemistry lab results (4)
    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)
    Item Group
    Date of Visit/ Assessment - End of Study
    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
    Status of Treatment Blind
    C0749659 (UMLS CUI-1)
    C2347038 (UMLS CUI-2)
    Was the treatment blind broken during the study?
    Item
    Was the treatment blind broken during the study?
    boolean
    C3897431 (UMLS CUI [1])
    Date blind broken
    Item
    If the treatment blind was broken during the study, complete Date blind broken.
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Reason for treatment blind was broken
    integer
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason for treatment blind was broken
    Code List
    Reason for treatment blind was broken
    CL Item
    Medical emergency requiring identification of investigational product for further treatment (1)
    CL Item
    Other, specify (2)
    If other Reason for treatment blind was broken, specify.
    Item
    If other Reason for treatment blind was broken, specify.
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Did the subject become pregnant during the study?
    Item
    Did the subject become pregnant during the study?
    boolean
    C3828490 (UMLS CUI [1])
    Item Group
    Pharmacogenetic (PGx) Research Withdrawal of Consent
    C2347500 (UMLS CUI-1)
    C0021430 (UMLS CUI-2)
    C2349954 (UMLS CUI-3)
    Has the subject withdrawn consent for PGx research?
    Item
    Has the subject withdrawn consent for PGx research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2349954 (UMLS CUI [1,3])
    Date informed consent withdrawn
    Item
    Date informed consent withdrawn
    date
    C0011008 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0009797 (UMLS CUI [1,3])
    Has a request been made for sample destruction?
    Item
    Has a request been made for sample destruction?
    boolean
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    Item
    If a request has been made for sample destruction, check reason.
    integer
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    Reason for request for sample destruction
    Code List
    If a request has been made for sample destruction, check reason.
    CL Item
    Subject withdrew consent for PGx (3)
    CL Item
    Screen failure (2)
    CL Item
    Other, speciy (1)
    If other reason for request for sample destruction, specify
    Item
    If other reason for request for sample destruction, specify.
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    Date of subject completion or withdrawal
    Item
    Date of subject completion or withdrawal
    date
    C0422727 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C1549507 (UMLS CUI [2])
    Item
    Was the subject withdrawn from the study?
    text
    C0422727 (UMLS CUI [1])
    Was the subject withdrawn from the study?
    Code List
    Was the subject withdrawn from the study?
    CL Item
    No (N)
    CL Item
    Yes, complete the primary reason for withdrawal (Y)
    Item
    Primary reason for withdrawal
    integer
    C0422727 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Primary reason for withdrawal
    Code List
    Primary reason for withdrawal
    CL Item
    Adverse Event (Record all details on the Non- Serious Adverse Events or Serious Adverse Events forms as approprioate) (1)
    CL Item
    Lack of efficacy (check all that apply. If none, select "No Subreasons") (2)
    CL Item
    No subreasons (99)
    CL Item
    Exacerbation (019)
    CL Item
    Exceeded rescue medication use (as defined in the protocol) (071)
    CL Item
    Below PEF stability limit (073)
    CL Item
    Below FEV1 stability limit (074)
    CL Item
    Asthma worsening requiring additional asthma medication (148)
    CL Item
    Protocol Deviation (check all that apply. If none, select "No Subreasons") (3)
    CL Item
    No subreasons (99)
    CL Item
    Pregnancy (024)
    CL Item
    Prohibited medication use (029)
    CL Item
    Subject reached protocol defined stopping criteria (4)
    CL Item
    Liver function test abnormality (017)
    CL Item
    ECG abnormality (007)
    CL Item
    Study closed/ terminated (5)
    CL Item
    Lost to Follow- up (6)
    CL Item
    Investigator discretion, specify (Select this reason if none of the other primary reasons are appropriate.) (7)
    CL Item
    Withdrew consent, specify: Select this reason if none of the other primary reasons are appropriate (8)
    Specify investigator discretion
    Item
    Specify investigator discretion
    text
    C0008961 (UMLS CUI [1,1])
    C0022423 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Withdrew consent specification
    Item
    Withdrew consent specification
    text
    C1707492 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item Group
    Investigator Signature
    C2346576 (UMLS CUI-1)
    Investigator Siganture
    Item
    Investigator Signature
    text
    C2346576 (UMLS CUI [1])
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