0 Ratings
ID

41568

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 (Modified Medical research council dyspnea scale (MMRC)) is to be filled out at Visit 2 (Randomisation). If MMRC score is < 2 subject should be reported as a Run-in Failure.

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

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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

    Modified Medical Research Council dyspnea scale (MMRC)

    1 forms  
    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
    Modified Medical Research Council Dyspnea Scale
    Description

    Modified Medical Research Council Dyspnea Scale

    Alias
    UMLS CUI-1
    C3826977
    Indicate the one response that applies
    Description

    Modified Medical Research Council Dyspnea Scale

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3826977
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    Similar models

    Modified Medical Research Council dyspnea scale (MMRC)

    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
    Modified Medical Research Council Dyspnea Scale
    C3826977 (UMLS CUI-1)
    Item
    Indicate the one response that applies
    integer
    C3826977 (UMLS CUI [1])
    MMRC
    Code List
    Indicate the one response that applies
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    0 (0)
    Back to the top of the page 

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