0 Evaluaciones

ID

34937

Descripción

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 Inhalation worksheet form. It has to be filled in for TP1-4 Day1.

Palabras clave

  1. 4/2/19 4/2/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

4 de febrero de 2019

DOI

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Licencia

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

    Inhalation worksheet

    1. StudyEvent: ODM
      1. Inhalation worksheet
    Administrative data
    Descripción

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject identifier
    Descripción

    Subject identifier

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Visit type
    Descripción

    Visit type

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Inhalation worksheet
    Descripción

    Inhalation worksheet

    Alias
    UMLS CUI-1
    C0001559 (Inhalation Drug Administration)
    SNOMED
    243132000
    Inhalation Number
    Descripción

    Note the numbers 1 to 10

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0205535 (Inhalation Route of Drug Administration)
    LOINC
    LA9427-1
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Start Time of inhalation
    Descripción

    Start Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    UMLS CUI [1,2]
    C0001559 (Inhalation Drug Administration)
    SNOMED
    243132000

    Similar models

    Inhalation worksheet

    1. StudyEvent: ODM
      1. Inhalation worksheet
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject identifier
    Item
    Subject identifier
    text
    C2348585 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Code List
    Visit type
    CL Item
    TP1D1 (1)
    CL Item
    TP2D1 (2)
    CL Item
    TP3D1 (3)
    CL Item
    TP4D1 (4)
    Item Group
    Inhalation worksheet
    C0001559 (UMLS CUI-1)
    Inhalation Number
    Item
    Inhalation Number
    integer
    C0205535 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Start Time
    Item
    Start Time of inhalation
    time
    C1301880 (UMLS CUI [1,1])
    C0001559 (UMLS CUI [1,2])

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