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24617

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Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

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  1. 08.08.17 08.08.17 -
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GlaxoSmithKline

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8. August 2017

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    baseline dyspnoea index salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    Englisch

    baseline dyspnoea index salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    1 Formulare  
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beschreibung

    subject identifier

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    BASELINE DYSPNOEA INDEX (BDI) WORKSHEET
    Beschreibung

    BASELINE DYSPNOEA INDEX (BDI) WORKSHEET

    Alias
    UMLS CUI-1
    C1511069
    Date of assessment
    Beschreibung

    assessment date of baseline dyspnoea index

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C2985720
    UMLS CUI [1,2]
    C1511069
    BDI: Job
    Beschreibung

    BDI: Job

    Alias
    UMLS CUI-1
    C0028811
    Functional Impairment
    Beschreibung

    types/kinds of activities

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3827376
    Magnitude of Task
    Beschreibung

    level, magnitude, extent

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3831386
    Magnitude of Effort
    Beschreibung

    time needed, pauses, exertion

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3831387
    Housework, shopping
    Beschreibung

    Housework, shopping

    Alias
    UMLS CUI-1
    C1571726
    UMLS CUI-3
    C0150768
    Functional Impairment
    Beschreibung

    types/kinds of activities

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3827376
    Magnitude of Task
    Beschreibung

    level, magnitude, extent

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3831386
    Magnitude of Effort
    Beschreibung

    time needed, pauses, exertion

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3831387
    Leisure activities, gardening
    Beschreibung

    Leisure activities, gardening

    Alias
    UMLS CUI-1
    C0023292
    UMLS CUI-3
    C0868963
    Functional Impairment
    Beschreibung

    types/kinds of activities

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3827376
    Magnitude of Task
    Beschreibung

    level, magnitude, extent

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3831386
    Magnitude of Effort
    Beschreibung

    time needed, pauses, exertion

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3831387
    Social activities
    Beschreibung

    Social activities

    Alias
    UMLS CUI-1
    C0814554
    Functional Impairment
    Beschreibung

    types/kinds of activities

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3827376
    Magnitude of Task
    Beschreibung

    level, magnitude, extent

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3831386
    Magnitude of Effort
    Beschreibung

    time needed, pauses, exertion

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3831387
    Washing/dressing
    Beschreibung

    Washing/dressing

    Alias
    UMLS CUI-1
    C0441648
    UMLS CUI-3
    C0518459
    Functional Impairment
    Beschreibung

    types/kinds of activities

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3827376
    Magnitude of Task
    Beschreibung

    level, magnitude, extent

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3831386
    Magnitude of Effort
    Beschreibung

    time needed, pauses, exertion

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3831387
    At rest
    Beschreibung

    At rest

    Alias
    UMLS CUI-1
    C0035253
    Functional Impairment
    Beschreibung

    types/kinds of activities

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3827376
    Magnitude of Task
    Beschreibung

    level, magnitude, extent

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3831386
    Magnitude of Effort
    Beschreibung

    time needed, pauses, exertion

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3831387
    Any other
    Beschreibung

    Any other

    Alias
    UMLS CUI-1
    C0205394
    Functional Impairment
    Beschreibung

    types/kinds of activities

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3827376
    Magnitude of Task
    Beschreibung

    level, magnitude, extent

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3831386
    Magnitude of Effort
    Beschreibung

    time needed, pauses, exertion

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3831387
    BDI Score
    Beschreibung

    BDI Score

    Alias
    UMLS CUI-1
    C1511069
    UMLS CUI-2
    C0449820
    BDI Total Score
    Beschreibung

    BDI score

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1511069
    UMLS CUI [1,2]
    C0449820
    Functional Impairment
    Beschreibung

    BDI - functional impairment score

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C3827376
    UMLS CUI [1,2]
    C0449820
    Magnitude of Task
    Beschreibung

    BDI - magnitude of task score

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C3831386
    UMLS CUI [1,2]
    C0449820
    Magnitude of Effort
    Beschreibung

    BDI - magnitude of effort score

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C3831387
    UMLS CUI [1,2]
    C0449820
    Date
    Beschreibung

    Date

    Alias
    UMLS CUI-1
    C0011008
    Date of assessment
    Beschreibung

    date of assessment

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2985720
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    Ähnliche Modelle

    baseline dyspnoea index salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    subject identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    BASELINE DYSPNOEA INDEX (BDI) WORKSHEET
    C1511069 (UMLS CUI-1)
    assessment date of baseline dyspnoea index
    Item
    Date of assessment
    date
    C2985720 (UMLS CUI [1,1])
    C1511069 (UMLS CUI [1,2])
    Item Group
    BDI: Job
    C0028811 (UMLS CUI-1)
    BDI - functional impairment
    Item
    Functional Impairment
    integer
    C3827376 (UMLS CUI [1])
    BDI - magnitude of task
    Item
    Magnitude of Task
    integer
    C3831386 (UMLS CUI [1])
    BDI - magnitude of effort
    Item
    Magnitude of Effort
    integer
    C3831387 (UMLS CUI [1])
    Item Group
    Housework, shopping
    C1571726 (UMLS CUI-1)
    C0150768 (UMLS CUI-3)
    BDI - functional impairment
    Item
    Functional Impairment
    integer
    C3827376 (UMLS CUI [1])
    BDI - magnitude of task
    Item
    Magnitude of Task
    integer
    C3831386 (UMLS CUI [1])
    BDI - magnitude of effort
    Item
    Magnitude of Effort
    integer
    C3831387 (UMLS CUI [1])
    Item Group
    Leisure activities, gardening
    C0023292 (UMLS CUI-1)
    C0868963 (UMLS CUI-3)
    BDI - functional impairment
    Item
    Functional Impairment
    integer
    C3827376 (UMLS CUI [1])
    BDI - magnitude of task
    Item
    Magnitude of Task
    integer
    C3831386 (UMLS CUI [1])
    BDI - magnitude of effort
    Item
    Magnitude of Effort
    integer
    C3831387 (UMLS CUI [1])
    Item Group
    Social activities
    C0814554 (UMLS CUI-1)
    BDI - functional impairment
    Item
    Functional Impairment
    integer
    C3827376 (UMLS CUI [1])
    BDI - magnitude of task
    Item
    Magnitude of Task
    integer
    C3831386 (UMLS CUI [1])
    BDI - magnitude of effort
    Item
    Magnitude of Effort
    integer
    C3831387 (UMLS CUI [1])
    Item Group
    Washing/dressing
    C0441648 (UMLS CUI-1)
    C0518459 (UMLS CUI-3)
    BDI - functional impairment
    Item
    Functional Impairment
    integer
    C3827376 (UMLS CUI [1])
    BDI - magnitude of task
    Item
    Magnitude of Task
    integer
    C3831386 (UMLS CUI [1])
    BDI - magnitude of effort
    Item
    Magnitude of Effort
    integer
    C3831387 (UMLS CUI [1])
    Item Group
    At rest
    C0035253 (UMLS CUI-1)
    BDI - functional impairment
    Item
    Functional Impairment
    integer
    C3827376 (UMLS CUI [1])
    BDI - magnitude of task
    Item
    Magnitude of Task
    integer
    C3831386 (UMLS CUI [1])
    BDI - magnitude of effort
    Item
    Magnitude of Effort
    integer
    C3831387 (UMLS CUI [1])
    Item Group
    Any other
    C0205394 (UMLS CUI-1)
    BDI - functional impairment
    Item
    Functional Impairment
    integer
    C3827376 (UMLS CUI [1])
    BDI - magnitude of task
    Item
    Magnitude of Task
    integer
    C3831386 (UMLS CUI [1])
    BDI - magnitude of effort
    Item
    Magnitude of Effort
    integer
    C3831387 (UMLS CUI [1])
    Item Group
    BDI Score
    C1511069 (UMLS CUI-1)
    C0449820 (UMLS CUI-2)
    BDI score
    Item
    BDI Total Score
    integer
    C1511069 (UMLS CUI [1,1])
    C0449820 (UMLS CUI [1,2])
    BDI - functional impairment score
    Item
    Functional Impairment
    integer
    C3827376 (UMLS CUI [1,1])
    C0449820 (UMLS CUI [1,2])
    BDI - magnitude of task score
    Item
    Magnitude of Task
    integer
    C3831386 (UMLS CUI [1,1])
    C0449820 (UMLS CUI [1,2])
    BDI - magnitude of effort score
    Item
    Magnitude of Effort
    integer
    C3831387 (UMLS CUI [1,1])
    C0449820 (UMLS CUI [1,2])
    Item Group
    Date
    C0011008 (UMLS CUI-1)
    date of assessment
    Item
    Date of assessment
    date
    C2985720 (UMLS CUI [1])
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