0 Avaliações
ID

41597

Descrição

Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (Smoking Status) is to be filled out at Visit 2, 3, 4, 5 and 6 and/or in case of early withdrawal.

Link

https://clinicaltrials.gov/ct2/show/NCT00784550

Palavras-chave

Versões (2)
  1. 19/11/2020 19/11/2020 -
  2. 19/11/2020 19/11/2020 -
Titular dos direitos

GlaxoSmithKline

Transferido a

19 de novembro de 2020

DOI

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Licença

Creative Commons BY-NC 4.0
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    Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550

    Inglês

    Smoking Status

    1 Formulários  
    1. StudyEvent: ODM
      1. Smoking Status
    Administrative Data
    Descrição

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject identification number
    Descrição

    Subject identification number

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date of visit/assessment
    Descrição

    Date of visit/assessment

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI [2]
    C2985720 (Assessment Date)
    Visit type
    Descrição

    Visit type

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Smoking Status
    Descrição

    Smoking Status

    Alias
    UMLS CUI-1
    C1519386 (Smoking Status)
    Has the subject smoked since the last visit?
    Descrição

    Smoked since last visit

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0453996 (Tobacco smoking behavior)
    SNOMED
    365981007
    UMLS CUI [1,2]
    C1711239 (Since)
    UMLS CUI [1,3]
    C0545082 (Visit)
    UMLS CUI [1,4]
    C1517741 (Last)
    LOINC
    LP200101-6
    Voltar ao início da página

    Similar models

    Smoking Status

    1 Formulários
    1. StudyEvent: ODM
      1. Smoking Status
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject identification number
    Item
    Subject identification number
    text
    C2348585 (UMLS CUI [1])
    Date of visit/assessment
    Item
    Date of visit/assessment
    date
    C1320303 (UMLS CUI [1])
    C2985720 (UMLS CUI [2])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    Visit 2 (1)
    CL Item
    Visit 3 (2)
    CL Item
    Visit 4 (3)
    CL Item
    Visit 5 (4)
    CL Item
    Visit 6 (5)
    CL Item
    Early Withdrawal (6)
    Item Group
    Smoking Status
    C1519386 (UMLS CUI-1)
    Item
    Has the subject smoked since the last visit?
    text
    C0453996 (UMLS CUI [1,1])
    C1711239 (UMLS CUI [1,2])
    C0545082 (UMLS CUI [1,3])
    C1517741 (UMLS CUI [1,4])
    Smoked since last visit
    Code List
    Has the subject smoked since the last visit?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Voltar ao início da página 

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