0 Avaliações

ID

34938

Descrição

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the Inhaler device training form. It has to be filled in for screening.

Palavras-chave

  1. 04/02/2019 04/02/2019 -
  2. 06/02/2019 06/02/2019 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

4 de fevereiro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0

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    Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

    Inhaler device training

    Administrative data
    Descrição

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject identifier
    Descrição

    Subject identifier

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Descrição

    day month year

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1320303
    Inhaler device training
    Descrição

    Inhaler device training

    Alias
    UMLS CUI-1
    C0030688
    UMLS CUI-2
    C0021461
    Has the subject received training on how to use the Diskus?
    Descrição

    Use of Diskus

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1524063
    UMLS CUI [1,2]
    C0021461
    UMLS CUI [1,3]
    C1553480
    Is the subject able to use the Diskus correctly?
    Descrição

    Note: If No, the subject is not eligible for the study.

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2349182
    UMLS CUI [1,2]
    C1524063
    UMLS CUI [1,3]
    C0021461
    UMLS CUI [1,4]
    C1553480

    Similar models

    Inhaler device training

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject identifier
    Item
    Subject identifier
    text
    C2348585 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Inhaler device training
    C0030688 (UMLS CUI-1)
    C0021461 (UMLS CUI-2)
    Item
    Has the subject received training on how to use the Diskus?
    text
    C1524063 (UMLS CUI [1,1])
    C0021461 (UMLS CUI [1,2])
    C1553480 (UMLS CUI [1,3])
    Code List
    Has the subject received training on how to use the Diskus?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Is the subject able to use the Diskus correctly?
    text
    C2349182 (UMLS CUI [1,1])
    C1524063 (UMLS CUI [1,2])
    C0021461 (UMLS CUI [1,3])
    C1553480 (UMLS CUI [1,4])
    Code List
    Is the subject able to use the Diskus correctly?
    CL Item
    Yes (Y)
    CL Item
    No (N)

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