0 Evaluaciones
ID

26162

Descripción

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.

Palabras clave

Versiones (1)
  1. 10/10/17 10/10/17 -
Titular de derechos de autor

Glaxo Smith Kline

Subido en

10 de octubre de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

    Sin comentarios

    Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

    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

    Inglés

    Subject Diary Card

    1 formularios  
    1. StudyEvent: ODM
      1. Subject Diary Card
    Subject Diary Card Run-In Period
    Descripción

    Subject Diary Card Run-In Period

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

    Subject number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Emergency contact Investigator
    Descripción

    Emergency contact Investigator

    Tipo de datos

    text

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

    Emergency contact Study site

    Tipo de datos

    text

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

    Emergency contact Hospital

    Tipo de datos

    integer

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

    Emergency contact Hospital

    Tipo de datos

    text

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

    Date and time of next clinic visit

    Tipo de datos

    datetime

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

    Study day Morning Dose

    Tipo de datos

    integer

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

    day month year

    Tipo de datos

    date

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

    00:00-23:59

    Tipo de datos

    time

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

    Number of inhalations Accuhaler

    Tipo de datos

    integer

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

    Number of inhalations BADPI

    Tipo de datos

    integer

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

    Study Day Evening Dose

    Tipo de datos

    integer

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

    day month year

    Tipo de datos

    date

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

    00:00-23:59

    Tipo de datos

    time

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

    Number of inhalations Accuhaler

    Tipo de datos

    integer

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

    Number of inhalations BADPI

    Tipo de datos

    integer

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

    Subject Diary Card Treatment Period 1

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

    Subject number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Emergency contact Investigator
    Descripción

    Emergency contact Investigator

    Tipo de datos

    text

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

    Emergency contact Study site

    Tipo de datos

    text

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

    Emergency contact Hospital

    Tipo de datos

    integer

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

    Emergency contact Hospital

    Tipo de datos

    text

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

    Date and time of next clinic visit

    Tipo de datos

    datetime

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

    Study day Morning Dose

    Tipo de datos

    integer

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

    day month year

    Tipo de datos

    date

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

    00:00-23:59

    Tipo de datos

    time

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

    Number of inhalations Accuhaler

    Tipo de datos

    integer

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

    Number of inhalations BADPI

    Tipo de datos

    integer

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

    Study Day Evening Dose

    Tipo de datos

    integer

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

    day month year

    Tipo de datos

    date

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

    00:00-23:59

    Tipo de datos

    time

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

    Number of inhalations Accuhaler

    Tipo de datos

    integer

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

    Number of inhalations BADPI

    Tipo de datos

    integer

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

    Subject Diary Card Treatment Period 2

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

    Subject number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Emergency contact Investigator
    Descripción

    Emergency contact Investigator

    Tipo de datos

    text

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

    Emergency contact Study site

    Tipo de datos

    text

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

    Emergency contact Hospital

    Tipo de datos

    integer

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

    Emergency contact Hospital

    Tipo de datos

    text

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

    Date and time of next clinic visit

    Tipo de datos

    datetime

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

    Study day Morning Dose

    Tipo de datos

    integer

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

    day month year

    Tipo de datos

    date

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

    00:00-23:59

    Tipo de datos

    time

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

    Number of inhalations Accuhaler

    Tipo de datos

    integer

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

    Number of inhalations BADPI

    Tipo de datos

    integer

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

    Study Day Evening Dose

    Tipo de datos

    integer

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

    day month year

    Tipo de datos

    date

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

    00:00-23:59

    Tipo de datos

    time

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

    Number of inhalations Accuhaler

    Tipo de datos

    integer

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

    Number of inhalations BADPI

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0354922
    UMLS CUI [1,2]
    C1705566
    Volver a la parte superior de la página

    Similar models

    Subject Diary Card

    1 formularios
    1. StudyEvent: ODM
      1. Subject Diary Card
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Volver a la parte superior de la página 

    Ayuda

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial