0 Beoordelingen
ID

41596

Beschrijving

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 (IP Container) is to be filled out at Visit 2, 3, 4 and 5. Record the identifying number from the investigational product container dispensed at each visit. Record once at Visits 2 and 3 and twice at Visits 4 and 5.

Link

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

Trefwoorden

Versies (1)
  1. 19-11-20 19-11-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

19 november 2020

DOI

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Licentie

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

    Engels

    IP Container

    1 Formulieren  
    1. StudyEvent: ODM
      1. IP Container
    Administrative Data
    Beschrijving

    Administrative Data

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

    Subject identification number

    Datatype

    text

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

    Date of visit/assessment

    Datatype

    date

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

    Visit type

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    IP Container
    Beschrijving

    IP Container

    Alias
    UMLS CUI-1
    C3898691 (Investigational Medicinal Product Documentation)
    UMLS CUI-2
    C0180098 (Containers)
    SNOMED
    706437002
    Investigational Product Container Number
    Beschrijving

    To be filled out once at visits 2 and 3 each and twice at visits 4 and 5.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C0180098 (Containers)
    SNOMED
    706437002
    UMLS CUI [1,3]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
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    Similar models

    IP Container

    1 Formulieren
    1. StudyEvent: ODM
      1. IP Container
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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
    text
    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)
    Item Group
    IP Container
    C3898691 (UMLS CUI-1)
    C0180098 (UMLS CUI-2)
    Investigational Product Container Number
    Item
    Investigational Product Container Number
    text
    C0304229 (UMLS CUI [1,1])
    C0180098 (UMLS CUI [1,2])
    C0600091 (UMLS CUI [1,3])
    Terug naar het begin van de pagina 

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