0 Ratings
ID

41566

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 (Investigational Product) is to be filled out during the study.

Link

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

Keywords

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

GlaxoSmithKline

Uploaded on

November 11, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550

    English

    Investigational Product

    1 forms  
    Administrative Data
    Description

    Administrative Data

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

    Subject identification number

    Data type

    text

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

    Date of visit/assessment

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI [2]
    C2985720 (Assessment Date)
    Investigational Product
    Description

    Investigational Product

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    Open-label treatment
    Description

    Open-label treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3640652 (Open Label Treatment Epoch)
    Open label treatment: Start date
    Description

    Open label treatment: Start date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3640652 (Open Label Treatment Epoch)
    UMLS CUI [1,2]
    C0808070 (Start Date)
    Open label treatment: Stop date
    Description

    Open label treatment: Stop date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3640652 (Open Label Treatment Epoch)
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Double-blind diskus
    Description

    Double-blind diskus

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013072 (Double-Blind Method)
    Double-blind Diskus: Start Date
    Description

    Double-blind Diskus: Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013072 (Double-Blind Method)
    UMLS CUI [1,2]
    C0808070 (Start Date)
    Double-blind Diskus: Stop Date
    Description

    Double-blind Diskus: Stop Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013072 (Double-Blind Method)
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Back to the top of the page

    Similar models

    Investigational Product

    1 forms
    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 Group
    Investigational Product
    C0304229 (UMLS CUI-1)
    Open-label treatment
    Item
    Open-label treatment
    boolean
    C3640652 (UMLS CUI [1])
    Open label treatment: Start date
    Item
    Open label treatment: Start date
    date
    C3640652 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Open label treatment: Stop date
    Item
    Open label treatment: Stop date
    date
    C3640652 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Double-blind diskus
    Item
    Double-blind diskus
    boolean
    C0013072 (UMLS CUI [1])
    Double-blind Diskus: Start Date
    Item
    Double-blind Diskus: Start Date
    date
    C0013072 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Double-blind Diskus: Stop Date
    Item
    Double-blind Diskus: Stop Date
    date
    C0013072 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial