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

Uploaded on

October 10, 2017

DOI

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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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Similar models

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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