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ID

33744

Description

Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the PGx-Pharmacogenetic research consent (PGx Consent) form. It has to be filled in for the end of study. This form should only exist once in the study and is conditional upon inclusion of Pharmacogenetics in the protocol.

Link

https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026

Keywords

Versions (1)
  1. 12/21/18 12/21/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 21, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

    English

    PGx-Pharmacogenetic research consent (PGx Consent)

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject identifier
    Description

    Subject identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    PGx-Pharmacogenetic research consent
    Description

    PGx-Pharmacogenetic research consent

    Alias
    UMLS CUI-1
    C0021430
    UMLS CUI-2
    C2347500
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    Description

    Informed consent for PGx-Pharmacogenetic research

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    If yes, record date informed consent obtained for PGx-Pharmacogenetic research
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0011008
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    Description

    Blood sample collection for PGx-pharmacogenetic (DNA) research

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C2347500
    If yes, record Date sample taken
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Reason for no informed consent for PGx-Pharmacogenetic research
    Description

    Reason for no informed consent for PGx-Pharmacogenetic research

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C1298908
    UMLS CUI [1,3]
    C0021430
    UMLS CUI [1,4]
    C2347500
    If other reason, please specify
    Description

    Other Reason for no informed consent for PGx-Pharmacogenetic research

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C1298908
    UMLS CUI [1,3]
    C0021430
    UMLS CUI [1,4]
    C2347500
    UMLS CUI [2]
    C0205394
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    Similar models

    PGx-Pharmacogenetic research consent (PGx Consent)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject identifier
    Item
    Subject identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    PGx-Pharmacogenetic research consent
    C0021430 (UMLS CUI-1)
    C2347500 (UMLS CUI-2)
    Item
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    text
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Informed consent for PGx-Pharmacogenetic research
    Code List
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of informed consent
    Item
    If yes, record date informed consent obtained for PGx-Pharmacogenetic research
    date
    C0021430 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    text
    C0005834 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Blood sample collection for PGx-pharmacogenetic (DNA) research
    Code List
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date sample taken
    Item
    If yes, record Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Item
    Reason for no informed consent for PGx-Pharmacogenetic research
    text
    C0392360 (UMLS CUI [1,1])
    C1298908 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [1,3])
    C2347500 (UMLS CUI [1,4])
    Reason for no informed consent for PGx-Pharmacogenetic research
    Code List
    Reason for no informed consent for PGx-Pharmacogenetic research
    CL Item
    Subject declined (1)
    CL Item
    Subject nos asked by Investigator (2)
    CL Item
    Other reason (Z)
    Other Reason for no informed consent for PGx-Pharmacogenetic research
    Item
    If other reason, please specify
    text
    C0392360 (UMLS CUI [1,1])
    C1298908 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [1,3])
    C2347500 (UMLS CUI [1,4])
    C0205394 (UMLS CUI [2])
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