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ID

44563

Descrizione

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, 8 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 logs and repeat. It has to be filled in for the end of study.

collegamento

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

Keywords

versioni (3)
  1. 20/12/18 20/12/18 -
  2. 20/12/18 20/12/18 -
  3. 27/09/21 27/09/21 -
Titolare del copyright

GlaxoSmithKline

Caricato su

27 settembre 2021

DOI

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Licenza

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

    Inglese

    Logs and repeat

    1 moduli  
    1. StudyEvent: ODM
      1. Logs and repeat
    Administrative data
    Descrizione

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Descrizione

    Subject number

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of visit/assessment
    Descrizione

    day month year

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C1320303
    Adverse event/Concomitant medication/unscheduled assessment check questions
    Descrizione

    Adverse event/Concomitant medication/unscheduled assessment check questions

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C2347852
    Were any concomitant medications taken by the subject during the study?
    Descrizione

    Take of concomitant medication

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2347852
    Did the subject experience any non-serious adverse events during the study?
    Descrizione

    Non-serious adverse events

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1518404
    Did the subject experience any investigational Product Device Malfunctions?
    Descrizione

    Investigational Product Device Malfunctions

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0086138
    Did the subject experience any serious adverse events during the study?
    Descrizione

    Serious adverse events

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1519255
    Were any unscheduled haematology or clinical chemistry samples taken?
    Descrizione

    Take of unscheduled haematology or clinical chemistry samples

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3854240
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [2,1]
    C3854240
    UMLS CUI [2,2]
    C0018941
    Were any unscheduled urinalysis samples taken?
    Descrizione

    Take of unscheduled urinalysis samples

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3854240
    UMLS CUI [1,2]
    C0042014
    Were any unscheduled ECGs performed?
    Descrizione

    Unscheduled ECGs

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3854240
    UMLS CUI [1,2]
    C0013798
    Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
    Descrizione

    Abnormal, clinically significant ECG

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C2985739
    Were any unscheduled vital signs recorded?
    Descrizione

    Unscheduled vital signs

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3854240
    UMLS CUI [1,2]
    C0518766
    Were any chest x-rays taken for suspected Pneumonia?
    Descrizione

    Take of chest x-rays

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0032285
    UMLS CUI [1,3]
    C0750491
    Were any unscheduled FEV1 performed?
    Descrizione

    Unscheduled FEV1

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3854240
    UMLS CUI [1,2]
    C0748133
    Were any unscheduled PK blood samples taken?
    Descrizione

    Take of unscheduled PK blood

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3854240
    UMLS CUI [1,2]
    C0031328
    UMLS CUI [2,1]
    C3854240
    UMLS CUI [2,2]
    C0178913
    Liver event
    Descrizione

    Liver event

    Alias
    UMLS CUI-1
    C0023884
    UMLS CUI-2
    C0877248
    Have liver chemistry results reached or exceeded protocol- defined investigational product stopping criteria?
    Descrizione

    lf Yes to Liver events, go to the LE DETAILS visit and complete the Liver event forms

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0023884
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [1,3]
    C2746065
    UMLS CUI [1,4]
    C0243161
    Ritorna all'inizio della pagina

    Similar models

    Logs and repeat

    1 moduli
    1. StudyEvent: ODM
      1. Logs and repeat
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Date of visit/assessment
    Item
    Date of visit/assessment
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Adverse event/Concomitant medication/unscheduled assessment check questions
    C0877248 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Item
    Were any concomitant medications taken by the subject during the study?
    text
    C2347852 (UMLS CUI [1])
    Take of concomitant medication
    Code List
    Were any concomitant medications taken by the subject during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Did the subject experience any non-serious adverse events during the study?
    text
    C1518404 (UMLS CUI [1])
    Take of concomitant medication
    Code List
    Did the subject experience any non-serious adverse events during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Did the subject experience any investigational Product Device Malfunctions?
    text
    C0304229 (UMLS CUI [1,1])
    C0086138 (UMLS CUI [1,2])
    Take of concomitant medication
    Code List
    Did the subject experience any investigational Product Device Malfunctions?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Did the subject experience any serious adverse events during the study?
    text
    C1519255 (UMLS CUI [1])
    Take of concomitant medication
    Code List
    Did the subject experience any serious adverse events during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Were any unscheduled haematology or clinical chemistry samples taken?
    text
    C3854240 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C3854240 (UMLS CUI [2,1])
    C0018941 (UMLS CUI [2,2])
    Take of concomitant medication
    Code List
    Were any unscheduled haematology or clinical chemistry samples taken?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Were any unscheduled urinalysis samples taken?
    text
    C3854240 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    Take of unscheduled urinalysis samples
    Code List
    Were any unscheduled urinalysis samples taken?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Were any unscheduled ECGs performed?
    text
    C3854240 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    Take of unscheduled urinalysis samples
    Code List
    Were any unscheduled ECGs performed?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
    text
    C0522055 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    Take of unscheduled urinalysis samples
    Code List
    Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Were any unscheduled vital signs recorded?
    text
    C3854240 (UMLS CUI [1,1])
    C0518766 (UMLS CUI [1,2])
    Take of unscheduled urinalysis samples
    Code List
    Were any unscheduled vital signs recorded?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Were any chest x-rays taken for suspected Pneumonia?
    text
    C0039985 (UMLS CUI [1,1])
    C0032285 (UMLS CUI [1,2])
    C0750491 (UMLS CUI [1,3])
    Take of unscheduled urinalysis samples
    Code List
    Were any chest x-rays taken for suspected Pneumonia?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Were any unscheduled FEV1 performed?
    text
    C3854240 (UMLS CUI [1,1])
    C0748133 (UMLS CUI [1,2])
    Take of unscheduled urinalysis samples
    Code List
    Were any unscheduled FEV1 performed?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Were any unscheduled PK blood samples taken?
    text
    C3854240 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    C3854240 (UMLS CUI [2,1])
    C0178913 (UMLS CUI [2,2])
    Take of unscheduled urinalysis samples
    Code List
    Were any unscheduled PK blood samples taken?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Liver event
    C0023884 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    Item
    Have liver chemistry results reached or exceeded protocol- defined investigational product stopping criteria?
    text
    C0023884 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C2746065 (UMLS CUI [1,3])
    C0243161 (UMLS CUI [1,4])
    Liver events reaching stopping criteria
    Code List
    Have liver chemistry results reached or exceeded protocol- defined investigational product stopping criteria?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Ritorna all'inizio della pagina 

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