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ID

24594

Description

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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Versions (3)
  1. 7/27/17 7/27/17 -
  2. 7/27/17 7/27/17 -
  3. 8/8/17 8/8/17 -
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August 8, 2017

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Creative Commons BY-NC 3.0
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    visit 2 (randomisation) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    English

    visit 2 (randomisation) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    subject identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Description

    date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    CURRENT TOBACCO USE
    Description

    CURRENT TOBACCO USE

    Alias
    UMLS CUI-1
    C0543414
    Has the subject smoked/used tobacco since the last visit?
    Description

    use of tobacco since last visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C0545082
    UMLS CUI [1,3]
    C1517741
    BASELINE DYSPNOEA INDEX (BDI)
    Description

    BASELINE DYSPNOEA INDEX (BDI)

    Alias
    UMLS CUI-1
    C1511069
    OROPHARYNGEAL CANDIDIASIS EXAMINATION
    Description

    OROPHARYNGEAL CANDIDIASIS EXAMINATION

    Alias
    UMLS CUI-1
    C0006849
    UMLS CUI-2
    C0582103
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    Description

    clinical evidence of oropharyngeal candidiasis

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0006849
    UMLS CUI [1,2]
    C3887511
    Was a swab taken?
    Description

    Swab need only be taken if there is clinical evidence of oropharyngeal candidiasis

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0006849
    UMLS CUI [1,2]
    C0563454
    if a swab was taken, result of the swab?
    Description

    oropharyngeal candidiasis test result

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0006849
    UMLS CUI [1,2]
    C0563454
    UMLS CUI [1,3]
    C1274040
    VITAL SIGNS
    Description

    VITAL SIGNS

    Alias
    UMLS CUI-1
    C0518766
    Blood pressure
    Description

    Position: sitting.

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Heart rate
    Description

    heart rate

    Data type

    integer

    Measurement units
    • beats/minute
    Alias
    UMLS CUI [1]
    C0018810
    beats/minute
    PULMONARY FUNCTION TESTING
    Description

    PULMONARY FUNCTION TESTING

    Alias
    UMLS CUI-1
    C0024119
    Has the subject taken VENTOLIN in the last 6 hours?
    Description

    ventolin taken in the last hours

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C1632850
    pulmonary funtion testing: FEV1
    Description

    pulmonary funtion testing: FEV1

    Alias
    UMLS CUI-1
    C0748133
    Time of Assessment PreVENTOLIN
    Description

    time of assessment before Ventolin

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0220825
    Actual Measurement PreVENTOLIN
    Description

    Actual Measurement PreVENTOLIN = A

    Data type

    float

    Measurement units
    • L
    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C0242485
    L
    pulmonary function testing: FVC
    Description

    pulmonary function testing: FVC

    Alias
    UMLS CUI-1
    C3714541
    Actual Measurement PreVENTOLIN
    Description

    Actual Measurement PreVENTOLIN = A

    Data type

    float

    Measurement units
    • L
    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C0242485
    L
    pulmonary function testing: FEV1 /FVC ratio
    Description

    pulmonary function testing: FEV1 /FVC ratio

    Alias
    UMLS CUI-1
    C0429745
    Actual Measurement PreVENTOLIN
    Description

    Actual Measurement PreVENTOLIN = A

    Data type

    float

    Measurement units
    • L
    Alias
    UMLS CUI [1,1]
    C0033744
    UMLS CUI [1,2]
    C0242485
    L
    ST. GEORGE’S RESPIRATORY QUESTIONNAIRE
    Description

    ST. GEORGE’S RESPIRATORY QUESTIONNAIRE

    Alias
    UMLS CUI-1
    C0451500
    Confirm the SGRQ has been completed by the subject
    Description

    SGRQ completed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0451500
    UMLS CUI [1,2]
    C0205197
    EQ-5D (Euroqol)
    Description

    EQ-5D (Euroqol)

    Alias
    UMLS CUI-1
    C2733251
    Confirm the EQ-5D has been completed by the subject.
    Description

    EQ-5D completed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2733251
    UMLS CUI [1,2]
    C0205197
    RANDOMISATION NUMBER
    Description

    RANDOMISATION NUMBER

    Alias
    UMLS CUI-1
    C0034656
    UMLS CUI-2
    C0237753
    Record randomisation number.
    Description

    randomisation number

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    INVESTIGATIONAL PRODUCT CONTAINER NUMBER
    Description

    INVESTIGATIONAL PRODUCT CONTAINER NUMBER

    Alias
    UMLS CUI-1
    C3898691
    UMLS CUI-2
    C0449788
    Record the identifying number from the investigational product container dispensed at this visit.
    Description

    investigational product containernumber

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3898691
    UMLS CUI [1,2]
    C0449788
    TRANSITION DYSPNOEA INDEX (TDI)
    Description

    TRANSITION DYSPNOEA INDEX (TDI)

    Alias
    UMLS CUI-1
    C3714807
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    Similar models

    visit 2 (randomisation) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    subject identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    date of visit
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    CURRENT TOBACCO USE
    C0543414 (UMLS CUI-1)
    Item
    Has the subject smoked/used tobacco since the last visit?
    text
    C0543414 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    C1517741 (UMLS CUI [1,3])
    use of tobacco since last visit
    Code List
    Has the subject smoked/used tobacco since the last visit?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    BASELINE DYSPNOEA INDEX (BDI)
    C1511069 (UMLS CUI-1)
    Item Group
    OROPHARYNGEAL CANDIDIASIS EXAMINATION
    C0006849 (UMLS CUI-1)
    C0582103 (UMLS CUI-2)
    Item
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    text
    C0006849 (UMLS CUI [1,1])
    C3887511 (UMLS CUI [1,2])
    clinical evidence of oropharyngeal candidiasis
    Code List
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Was a swab taken?
    text
    C0006849 (UMLS CUI [1,1])
    C0563454 (UMLS CUI [1,2])
    taking of a swab
    Code List
    Was a swab taken?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    if a swab was taken, result of the swab?
    integer
    C0006849 (UMLS CUI [1,1])
    C0563454 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    oropharyngeal candidiasis test result
    Code List
    if a swab was taken, result of the swab?
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    CL Item
    Not available (4)
    Item Group
    VITAL SIGNS
    C0518766 (UMLS CUI-1)
    blood pressure
    Item
    Blood pressure
    integer
    C0005823 (UMLS CUI [1])
    heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    PULMONARY FUNCTION TESTING
    C0024119 (UMLS CUI-1)
    Item
    Has the subject taken VENTOLIN in the last 6 hours?
    text
    C0033744 (UMLS CUI [1,1])
    C1632850 (UMLS CUI [1,2])
    use of bronchodilatators before lung function measurement
    Code List
    Has the subject taken VENTOLIN in the last 6 hours?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    pulmonary funtion testing: FEV1
    C0748133 (UMLS CUI-1)
    time of assessment before Ventolin
    Item
    Time of Assessment PreVENTOLIN
    time
    C0033744 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0220825 (UMLS CUI [1,3])
    measurement before Ventolin
    Item
    Actual Measurement PreVENTOLIN
    float
    C0033744 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    Item Group
    pulmonary function testing: FVC
    C3714541 (UMLS CUI-1)
    measurement before Ventolin
    Item
    Actual Measurement PreVENTOLIN
    float
    C0033744 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    Item Group
    pulmonary function testing: FEV1 /FVC ratio
    C0429745 (UMLS CUI-1)
    measurement before Ventolin
    Item
    Actual Measurement PreVENTOLIN
    float
    C0033744 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    Item Group
    ST. GEORGE’S RESPIRATORY QUESTIONNAIRE
    C0451500 (UMLS CUI-1)
    SGRQ completed
    Item
    Confirm the SGRQ has been completed by the subject
    boolean
    C0451500 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Item Group
    EQ-5D (Euroqol)
    C2733251 (UMLS CUI-1)
    EQ-5D completed
    Item
    Confirm the EQ-5D has been completed by the subject.
    boolean
    C2733251 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Item Group
    RANDOMISATION NUMBER
    C0034656 (UMLS CUI-1)
    C0237753 (UMLS CUI-2)
    randomisation number
    Item
    Record randomisation number.
    float
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Item Group
    INVESTIGATIONAL PRODUCT CONTAINER NUMBER
    C3898691 (UMLS CUI-1)
    C0449788 (UMLS CUI-2)
    investigational product containernumber
    Item
    Record the identifying number from the investigational product container dispensed at this visit.
    integer
    C3898691 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Item Group
    TRANSITION DYSPNOEA INDEX (TDI)
    C3714807 (UMLS CUI-1)
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