0 Beoordelingen
ID

41561

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 (COPD and Smoking History) is to be filled out during the study.

Link

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

Trefwoorden

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

GlaxoSmithKline

Geüploaded op

11 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

    COPD and Smoking History

    1 Formulieren  
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject identification number
    Beschrijving

    Subject identification number

    Datatype

    text

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

    Date of visit/assessment

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303
    UMLS CUI [2]
    C2985720
    Duration of COPD
    Beschrijving

    Duration of COPD

    Alias
    UMLS CUI-1
    C0872146
    UMLS CUI-2
    C0024117
    Duration in years
    Beschrijving

    This item is optional

    Datatype

    integer

    Maateenheden
    • years
    Alias
    UMLS CUI [1,1]
    C0872146
    UMLS CUI [1,2]
    C0024117
    years
    Duration in months
    Beschrijving

    This item is optional

    Datatype

    integer

    Maateenheden
    • months
    Alias
    UMLS CUI [1,1]
    C0872146
    UMLS CUI [1,2]
    C0024117
    months
    History of COPD Exacerbations
    Beschrijving

    History of COPD Exacerbations

    Alias
    UMLS CUI-1
    C0740304
    UMLS CUI-2
    C0262926
    Number of exacerbations in the last [12 months] that required oral/systemic corticosteroids and/or antibiotics (not involving hospitalisation)
    Beschrijving

    If none, enter 0 (zero) 'oral corticosteroids', 'systemic corticosteroids', 'corticosteroids' and/or 'antibiotics' are all acceptable options

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0332185
    UMLS CUI [1,2]
    C0740304
    UMLS CUI [1,3]
    C0449788
    UMLS CUI [1,4]
    C2825233
    UMLS CUI [1,5]
    C0019993
    UMLS CUI [1,6]
    C1611645
    UMLS CUI [2,1]
    C0332185
    UMLS CUI [2,2]
    C0740304
    UMLS CUI [2,3]
    C0449788
    UMLS CUI [2,4]
    C0574135
    UMLS CUI [2,5]
    C0019993
    UMLS CUI [2,6]
    C1611645
    UMLS CUI [3,1]
    C0332185
    UMLS CUI [3,2]
    C0740304
    UMLS CUI [3,3]
    C0449788
    UMLS CUI [3,4]
    C0003232
    UMLS CUI [3,5]
    C0019993
    UMLS CUI [3,6]
    C1611645
    Number of exacerbations in the last [12 months] that required hospitalisation.
    Beschrijving

    If none, enter 0 (zero)

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0332185
    UMLS CUI [1,2]
    C0740304
    UMLS CUI [1,3]
    C0449788
    UMLS CUI [1,4]
    C1708385
    COPD type
    Beschrijving

    COPD type

    Alias
    UMLS CUI-1
    C0024117
    UMLS CUI-2
    C0332307
    COPD type: chronic bronchitis
    Beschrijving

    Optional item to be included ONLY for COPD studies and ONLY IF specified in the protocol.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0008677
    UMLS CUI [1,2]
    C0024117
    COPD type: Emphysema
    Beschrijving

    Optional item to be included ONLY for COPD studies and ONLY IF specified in the protocol.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0024117
    UMLS CUI [1,2]
    C0034067
    Smoking History
    Beschrijving

    Smoking History

    Alias
    UMLS CUI-1
    C1519384
    What is the subject's history of tobacco use?
    Beschrijving

    History of tobacco use

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0841002
    Average number of cigarettes smoked per pay
    Beschrijving

    Average number of cigarettes per day

    Datatype

    integer

    Maateenheden
    • cigarettes per day
    Alias
    UMLS CUI [1,1]
    C3694146
    UMLS CUI [1,2]
    C1510992
    cigarettes per day
    Number of years the subject has smoked
    Beschrijving

    Years smoked

    Datatype

    integer

    Maateenheden
    • years
    Alias
    UMLS CUI [1]
    C3694955
    years
    Number of pack years
    Beschrijving

    This item will be calculated by InForm using the following formula: Average number of cigarettes smoked per day divided by 20 and then multiplied by number of years smoked. Round up/down to nearest integer.

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1277691
    Substance Use Type
    Beschrijving

    [hidden] This item will be calculated by InForm

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0439861
    UMLS CUI [1,2]
    C1524063
    UMLS CUI [1,3]
    C0332307
    Terug naar het begin van de pagina

    Similar models

    COPD and Smoking History

    1 Formulieren
    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 Group
    Duration of COPD
    C0872146 (UMLS CUI-1)
    C0024117 (UMLS CUI-2)
    COPD Duration
    Item
    Duration in years
    integer
    C0872146 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    COPD Duration
    Item
    Duration in months
    integer
    C0872146 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    Item Group
    History of COPD Exacerbations
    C0740304 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    Number of recent COPD exacerbations requiring corticosteroids (oral/systemic) and/or antibiotics, not involving hospitalisation
    Item
    Number of exacerbations in the last [12 months] that required oral/systemic corticosteroids and/or antibiotics (not involving hospitalisation)
    integer
    C0332185 (UMLS CUI [1,1])
    C0740304 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    C2825233 (UMLS CUI [1,4])
    C0019993 (UMLS CUI [1,5])
    C1611645 (UMLS CUI [1,6])
    C0332185 (UMLS CUI [2,1])
    C0740304 (UMLS CUI [2,2])
    C0449788 (UMLS CUI [2,3])
    C0574135 (UMLS CUI [2,4])
    C0019993 (UMLS CUI [2,5])
    C1611645 (UMLS CUI [2,6])
    C0332185 (UMLS CUI [3,1])
    C0740304 (UMLS CUI [3,2])
    C0449788 (UMLS CUI [3,3])
    C0003232 (UMLS CUI [3,4])
    C0019993 (UMLS CUI [3,5])
    C1611645 (UMLS CUI [3,6])
    Number of recent COPD exacerbations requiring hospitalisation
    Item
    Number of exacerbations in the last [12 months] that required hospitalisation.
    integer
    C0332185 (UMLS CUI [1,1])
    C0740304 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    C1708385 (UMLS CUI [1,4])
    Item Group
    COPD type
    C0024117 (UMLS CUI-1)
    C0332307 (UMLS CUI-2)
    COPD type chronic bronchitis
    Item
    COPD type: chronic bronchitis
    boolean
    C0008677 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    COPD type Emphysema
    Item
    COPD type: Emphysema
    boolean
    C0024117 (UMLS CUI [1,1])
    C0034067 (UMLS CUI [1,2])
    Item Group
    Smoking History
    C1519384 (UMLS CUI-1)
    Item
    What is the subject's history of tobacco use?
    integer
    C0841002 (UMLS CUI [1])
    History of tobacco use
    Code List
    What is the subject's history of tobacco use?
    CL Item
    Current smoker (2)
    CL Item
    Former smoker (3)
    Average number of cigarettes per day
    Item
    Average number of cigarettes smoked per pay
    integer
    C3694146 (UMLS CUI [1,1])
    C1510992 (UMLS CUI [1,2])
    Years smoked
    Item
    Number of years the subject has smoked
    integer
    C3694955 (UMLS CUI [1])
    Number of pack years
    Item
    Number of pack years
    integer
    C1277691 (UMLS CUI [1])
    Substance Use Type
    Item
    Substance Use Type
    text
    C0439861 (UMLS CUI [1,1])
    C1524063 (UMLS CUI [1,2])
    C0332307 (UMLS CUI [1,3])
    Terug naar het begin van de pagina 

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