0 Ratings
ID

41596

Description

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

Keywords

Versions (1)
  1. 11/19/20 11/19/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 19, 2020

DOI

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License

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

    English

    IP Container

    1 forms  
    1. StudyEvent: ODM
      1. IP Container
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject identification number
    Description

    Subject identification number

    Data type

    text

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

    Date of visit/assessment

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    UMLS CUI [2]
    C2985720
    Visit type
    Description

    Visit type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    IP Container
    Description

    IP Container

    Alias
    UMLS CUI-1
    C3898691
    UMLS CUI-2
    C0180098
    Investigational Product Container Number
    Description

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

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0180098
    UMLS CUI [1,3]
    C0600091
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    Similar models

    IP Container

    1 forms
    1. StudyEvent: ODM
      1. IP Container
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
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