0 Ratings
ID

26162

Description

Randomised, open label, two period, crossover study to compare the steroid systemic exposure of Fluticasone Propionate (FP) from FP/Salmeterol (SALM) (500/50) DISKUS and Budesonide (BUD) from BUD/formoterol (FOR).(200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Primary objective:To compare the exposure of the inhaled steroid fluticasone propionate (FP) and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation twice daily (b.i.d.) when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe chronic pulmonary obstructive disease (COPD) population. Secondary objectives:To compare the pharmacokinetics of FP and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation b.i.d. when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe COPD population and to explore further the pharmacokinetics of FP and budesonide.

Keywords

Versions (1)
  1. 10/10/17 10/10/17 -
Copyright Holder

Glaxo Smith Kline

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October 10, 2017

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License

Creative Commons BY-NC 3.0
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    GSK Study ID 100807 Fluticasone Propionate from SERETIDE™ (500/50) DISKUS™ and Budesonide from Symbicort (200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Subject Diary Card

    English

    Subject Diary Card

    1 forms  
    1. StudyEvent: ODM
      1. Subject Diary Card
    Subject Diary Card Run-In Period
    Description

    Subject Diary Card Run-In Period

    Alias
    UMLS CUI-1
    C3890583
    UMLS CUI-2
    C3274438
    Subject number
    Description

    Subject number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Emergency contact Investigator
    Description

    Emergency contact Investigator

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2735018
    UMLS CUI [1,2]
    C0008961
    Emergency Study contact
    Description

    Emergency contact Study site

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2735018
    UMLS CUI [1,2]
    C2347790
    Hospital/Clinic telephone
    Description

    Emergency contact Hospital

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2735018
    UMLS CUI [1,2]
    C0019994
    Emergency contact Hospital/clinic address
    Description

    Emergency contact Hospital

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2735018
    UMLS CUI [1,2]
    C2986046
    Date and time of next clinic visit
    Description

    Date and time of next clinic visit

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2735341
    Study day Morning Dose
    Description

    Study day Morning Dose

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2826182
    UMLS CUI [1,2]
    C0332170
    Date of Dose
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0011008
    Time of Dose
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0040223
    Number of inhalations Accuhaler
    Description

    Number of inhalations Accuhaler

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0354922
    UMLS CUI [1,2]
    C1705566
    Number of inhalations BADPI
    Description

    Number of inhalations BADPI

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0354922
    UMLS CUI [1,2]
    C1705566
    Study Day Evening Dose
    Description

    Study Day Evening Dose

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2826182
    UMLS CUI [1,2]
    C0587117
    Date of Dose
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0011008
    Time of Dose
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0040223
    Number of inhalations Accuhaler
    Description

    Number of inhalations Accuhaler

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0354922
    UMLS CUI [1,2]
    C1705566
    Number of inhalations BADPI
    Description

    Number of inhalations BADPI

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0354922
    UMLS CUI [1,2]
    C1705566
    Subject Diary Card Treatment Period 1
    Description

    Subject Diary Card Treatment Period 1

    Alias
    UMLS CUI-1
    C3890583
    UMLS CUI-2
    C0087111
    UMLS CUI-3
    C1948053
    Subject number
    Description

    Subject number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Emergency contact Investigator
    Description

    Emergency contact Investigator

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2735018
    UMLS CUI [1,2]
    C0008961
    Emergency Study contact
    Description

    Emergency contact Study site

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2735018
    UMLS CUI [1,2]
    C2347790
    Hospital/Clinic telephone
    Description

    Emergency contact Hospital

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2735018
    UMLS CUI [1,2]
    C0019994
    Emergency contact Hospital/clinic address
    Description

    Emergency contact Hospital

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2735018
    UMLS CUI [1,2]
    C2986046
    Date and time of next clinic visit
    Description

    Date and time of next clinic visit

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2735341
    Study day Morning Dose
    Description

    Study day Morning Dose

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2826182
    UMLS CUI [1,2]
    C0332170
    Date of Dose
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0011008
    Time of Dose
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0040223
    Number of inhalations Accuhaler
    Description

    Number of inhalations Accuhaler

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0354922
    UMLS CUI [1,2]
    C1705566
    Number of inhalations BADPI
    Description

    Number of inhalations BADPI

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0354922
    UMLS CUI [1,2]
    C1705566
    Study Day Evening Dose
    Description

    Study Day Evening Dose

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2826182
    UMLS CUI [1,2]
    C0587117
    Date of Dose
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0011008
    Time of Dose
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0040223
    Number of inhalations Accuhaler
    Description

    Number of inhalations Accuhaler

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0354922
    UMLS CUI [1,2]
    C1705566
    Number of inhalations BADPI
    Description

    Number of inhalations BADPI

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0354922
    UMLS CUI [1,2]
    C1705566
    Subject Diary Card Treatment Period 2
    Description

    Subject Diary Card Treatment Period 2

    Alias
    UMLS CUI-1
    C3890583
    UMLS CUI-2
    C0087111
    UMLS CUI-3
    C1948053
    Subject number
    Description

    Subject number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Emergency contact Investigator
    Description

    Emergency contact Investigator

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2735018
    UMLS CUI [1,2]
    C0008961
    Emergency Study contact
    Description

    Emergency contact Study site

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2735018
    UMLS CUI [1,2]
    C2347790
    Hospital/Clinic telephone
    Description

    Emergency contact Hospital

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2735018
    UMLS CUI [1,2]
    C0019994
    Emergency contact Hospital/clinic address
    Description

    Emergency contact Hospital

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2735018
    UMLS CUI [1,2]
    C2986046
    Date and time of next clinic visit
    Description

    Date and time of next clinic visit

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2735341
    Study day Morning Dose
    Description

    Study day Morning Dose

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2826182
    UMLS CUI [1,2]
    C0332170
    Date of Dose
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0011008
    Time of Dose
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0040223
    Number of inhalations Accuhaler
    Description

    Number of inhalations Accuhaler

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0354922
    UMLS CUI [1,2]
    C1705566
    Number of inhalations BADPI
    Description

    Number of inhalations BADPI

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0354922
    UMLS CUI [1,2]
    C1705566
    Study Day Evening Dose
    Description

    Study Day Evening Dose

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2826182
    UMLS CUI [1,2]
    C0587117
    Date of Dose
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0011008
    Time of Dose
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0040223
    Number of inhalations Accuhaler
    Description

    Number of inhalations Accuhaler

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0354922
    UMLS CUI [1,2]
    C1705566
    Number of inhalations BADPI
    Description

    Number of inhalations BADPI

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0354922
    UMLS CUI [1,2]
    C1705566
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    Subject Diary Card

    1 forms
    1. StudyEvent: ODM
      1. Subject Diary Card
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Subject Diary Card Run-In Period
    C3890583 (UMLS CUI-1)
    C3274438 (UMLS CUI-2)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Emergency contact Investigator
    Item
    Emergency contact Investigator
    text
    C2735018 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Emergency contact Study site
    Item
    Emergency Study contact
    text
    C2735018 (UMLS CUI [1,1])
    C2347790 (UMLS CUI [1,2])
    Emergency contact Hospital
    Item
    Hospital/Clinic telephone
    integer
    C2735018 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Emergency contact Hospital
    Item
    Emergency contact Hospital/clinic address
    text
    C2735018 (UMLS CUI [1,1])
    C2986046 (UMLS CUI [1,2])
    Date and time of next clinic visit
    Item
    Date and time of next clinic visit
    datetime
    C2735341 (UMLS CUI [1])
    Item
    Study day Morning Dose
    integer
    C2826182 (UMLS CUI [1,1])
    C0332170 (UMLS CUI [1,2])
    Study day Morning Dose
    Code List
    Study day Morning Dose
    CL Item
    Day1 (1)
    CL Item
    Day2 (2)
    CL Item
    Day3 (3)
    CL Item
    Day4 (4)
    CL Item
    Day5 (5)
    CL Item
    Day6 (6)
    CL Item
    Day7 (7)
    CL Item
    Day8 (8)
    CL Item
    Day9 (9)
    CL Item
    Day10 (10)
    CL Item
    Day11 (11)
    CL Item
    Day12 (12)
    CL Item
    Day13 (13)
    CL Item
    Day14 (14)
    CL Item
    Day15 (15)
    CL Item
    Day16 (16)
    Date of Dose
    Item
    Date of Dose
    date
    C0304229 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of Dose
    Item
    Time of Dose
    time
    C0304229 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Number of inhalations Accuhaler
    Item
    Number of inhalations Accuhaler
    integer
    C0354922 (UMLS CUI [1,1])
    C1705566 (UMLS CUI [1,2])
    Number of inhalations BADPI
    Item
    Number of inhalations BADPI
    integer
    C0354922 (UMLS CUI [1,1])
    C1705566 (UMLS CUI [1,2])
    Item
    Study Day Evening Dose
    integer
    C2826182 (UMLS CUI [1,1])
    C0587117 (UMLS CUI [1,2])
    Study day Morning Dose
    Code List
    Study Day Evening Dose
    CL Item
    Day1 (1)
    CL Item
    Day2 (2)
    CL Item
    Day3 (3)
    CL Item
    Day4 (4)
    CL Item
    Day5 (5)
    CL Item
    Day6 (6)
    CL Item
    Day7 (7)
    CL Item
    Day8 (8)
    CL Item
    Day9 (9)
    CL Item
    Day10 (10)
    CL Item
    Day11 (11)
    CL Item
    Day12 (12)
    CL Item
    Day13 (13)
    CL Item
    Day14 (14)
    CL Item
    Day15 (15)
    CL Item
    Day16 (16)
    Date of Dose
    Item
    Date of Dose
    date
    C0304229 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of Dose
    Item
    Time of Dose
    time
    C0304229 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Number of inhalations Accuhaler
    Item
    Number of inhalations Accuhaler
    integer
    C0354922 (UMLS CUI [1,1])
    C1705566 (UMLS CUI [1,2])
    Number of inhalations BADPI
    Item
    Number of inhalations BADPI
    integer
    C0354922 (UMLS CUI [1,1])
    C1705566 (UMLS CUI [1,2])
    Item Group
    Subject Diary Card Treatment Period 1
    C3890583 (UMLS CUI-1)
    C0087111 (UMLS CUI-2)
    C1948053 (UMLS CUI-3)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Emergency contact Investigator
    Item
    Emergency contact Investigator
    text
    C2735018 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Emergency contact Study site
    Item
    Emergency Study contact
    text
    C2735018 (UMLS CUI [1,1])
    C2347790 (UMLS CUI [1,2])
    Emergency contact Hospital
    Item
    Hospital/Clinic telephone
    integer
    C2735018 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Emergency contact Hospital
    Item
    Emergency contact Hospital/clinic address
    text
    C2735018 (UMLS CUI [1,1])
    C2986046 (UMLS CUI [1,2])
    Date and time of next clinic visit
    Item
    Date and time of next clinic visit
    datetime
    C2735341 (UMLS CUI [1])
    Item
    Study day Morning Dose
    integer
    C2826182 (UMLS CUI [1,1])
    C0332170 (UMLS CUI [1,2])
    Study day Morning Dose
    Code List
    Study day Morning Dose
    CL Item
    Day1 (1)
    (Comment:en)
    CL Item
    Day2 (2)
    (Comment:en)
    CL Item
    Day3 (3)
    (Comment:en)
    CL Item
    Day4 (4)
    (Comment:en)
    CL Item
    Day5 (5)
    (Comment:en)
    CL Item
    Day6 (6)
    (Comment:en)
    CL Item
    Day7 (7)
    (Comment:en)
    Date of Dose
    Item
    Date of Dose
    date
    C0304229 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of Dose
    Item
    Time of Dose
    time
    C0304229 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Number of inhalations Accuhaler
    Item
    Number of inhalations Accuhaler
    integer
    C0354922 (UMLS CUI [1,1])
    C1705566 (UMLS CUI [1,2])
    Number of inhalations BADPI
    Item
    Number of inhalations BADPI
    integer
    C0354922 (UMLS CUI [1,1])
    C1705566 (UMLS CUI [1,2])
    Item
    Study Day Evening Dose
    integer
    C2826182 (UMLS CUI [1,1])
    C0587117 (UMLS CUI [1,2])
    Study day Morning Dose
    Code List
    Study Day Evening Dose
    CL Item
    Day1 (1)
    (Comment:en)
    CL Item
    Day2 (2)
    (Comment:en)
    CL Item
    Day3 (3)
    (Comment:en)
    CL Item
    Day4 (4)
    (Comment:en)
    CL Item
    Day5 (5)
    (Comment:en)
    CL Item
    Day6 (6)
    (Comment:en)
    CL Item
    Day7 (7)
    (Comment:en)
    Date of Dose
    Item
    Date of Dose
    date
    C0304229 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of Dose
    Item
    Time of Dose
    time
    C0304229 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Number of inhalations Accuhaler
    Item
    Number of inhalations Accuhaler
    integer
    C0354922 (UMLS CUI [1,1])
    C1705566 (UMLS CUI [1,2])
    Number of inhalations BADPI
    Item
    Number of inhalations BADPI
    integer
    C0354922 (UMLS CUI [1,1])
    C1705566 (UMLS CUI [1,2])
    Item Group
    Subject Diary Card Treatment Period 2
    C3890583 (UMLS CUI-1)
    C0087111 (UMLS CUI-2)
    C1948053 (UMLS CUI-3)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Emergency contact Investigator
    Item
    Emergency contact Investigator
    text
    C2735018 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Emergency contact Study site
    Item
    Emergency Study contact
    text
    C2735018 (UMLS CUI [1,1])
    C2347790 (UMLS CUI [1,2])
    Emergency contact Hospital
    Item
    Hospital/Clinic telephone
    integer
    C2735018 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Emergency contact Hospital
    Item
    Emergency contact Hospital/clinic address
    text
    C2735018 (UMLS CUI [1,1])
    C2986046 (UMLS CUI [1,2])
    Date and time of next clinic visit
    Item
    Date and time of next clinic visit
    datetime
    C2735341 (UMLS CUI [1])
    Item
    Study day Morning Dose
    integer
    C2826182 (UMLS CUI [1,1])
    C0332170 (UMLS CUI [1,2])
    Study day Morning Dose
    Code List
    Study day Morning Dose
    CL Item
    Day1 (1)
    (Comment:en)
    CL Item
    Day2 (2)
    (Comment:en)
    CL Item
    Day3 (3)
    (Comment:en)
    CL Item
    Day4 (4)
    (Comment:en)
    CL Item
    Day5 (5)
    (Comment:en)
    CL Item
    Day6 (6)
    (Comment:en)
    CL Item
    Day7 (7)
    (Comment:en)
    Date of Dose
    Item
    Date of Dose
    date
    C0304229 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of Dose
    Item
    Time of Dose
    time
    C0304229 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Number of inhalations Accuhaler
    Item
    Number of inhalations Accuhaler
    integer
    C0354922 (UMLS CUI [1,1])
    C1705566 (UMLS CUI [1,2])
    Number of inhalations BADPI
    Item
    Number of inhalations BADPI
    integer
    C0354922 (UMLS CUI [1,1])
    C1705566 (UMLS CUI [1,2])
    Item
    Study Day Evening Dose
    integer
    C2826182 (UMLS CUI [1,1])
    C0587117 (UMLS CUI [1,2])
    Study day Morning Dose
    Code List
    Study Day Evening Dose
    CL Item
    Day1 (1)
    (Comment:en)
    CL Item
    Day2 (2)
    (Comment:en)
    CL Item
    Day3 (3)
    (Comment:en)
    CL Item
    Day4 (4)
    (Comment:en)
    CL Item
    Day5 (5)
    (Comment:en)
    CL Item
    Day6 (6)
    (Comment:en)
    CL Item
    Day7 (7)
    (Comment:en)
    Date of Dose
    Item
    Date of Dose
    date
    C0304229 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of Dose
    Item
    Time of Dose
    time
    C0304229 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Number of inhalations Accuhaler
    Item
    Number of inhalations Accuhaler
    integer
    C0354922 (UMLS CUI [1,1])
    C1705566 (UMLS CUI [1,2])
    Number of inhalations BADPI
    Item
    Number of inhalations BADPI
    integer
    C0354922 (UMLS CUI [1,1])
    C1705566 (UMLS CUI [1,2])
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