ID

25979

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. 2/10/17 2/10/17 -
Titular de derechos de autor

Glaxo Smith Kline

Subido en

2 de octubre de 2017

DOI

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Licencia

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. Main CRF (PK Day- Treatment Period 2)

Inglés

Main CRF (PK Day - Treatment Period 2)

1 formularios  
Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry Worksheet
Descripción

Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry Worksheet

Alias
UMLS CUI-1
C1321605
UMLS CUI-2
C0021822
UMLS CUI-4
C2347852
UMLS CUI-5
C0021822
UMLS CUI-7
C0877248
UMLS CUI-8
C0021822
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Investigator number
Descripción

Investigator Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826689
Treatment Number
Descripción

Treatment Number

Tipo de datos

text

Alias
UMLS CUI [1]
C1522541
Date of assessment
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1]
C2985720
Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
Descripción

Compliance behavior

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
Is the subject aware of any forthcoming requirements?
Descripción

Compliance behavior limited

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
Comments
Descripción

Comments

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Has the subject used any concomitant medications?
Descripción

If YES, record on CONCOMITANT MEDICATIONS page(s).

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
Has there been any change in the state of the subject's health?
Descripción

If YES record any adverse events as per protocol.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C0392747
Collect the Treatment Period Subject Diary Card issued on Day 1 (Treatment Period 2) and transcribe the data, as appropriate, to the INVESTIGATIONAL PRODUCT page in this CRF. Collect the study medication issued on Day 1 (Treatment Period 2). If the subject is eligible to continue in the study do the following at the end of this visit: Make an appointment for the subject to return to the clinic in 4-10 days for a Follow-up visit.
Descripción

Eligibility

Tipo de datos

text

Alias
UMLS CUI [1]
C0013893
Vital Signs - Morning Dose
Descripción

Vital Signs - Morning Dose

Alias
UMLS CUI-1
C0518766
Date
Descripción

Vital Signs Assessment Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2985720
Planned Relative Time
Descripción

time relative to dosing

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual Time
Descripción

vital signs time

Tipo de datos

time

Alias
UMLS CUI [1]
C2826762
Systolic blood pressure
Descripción

Systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Pharmacokinetic Sampling - Morning Dose
Descripción

Pharmacokinetic Sampling - Morning Dose

Alias
UMLS CUI-1
C0201734
Date
Descripción

sample date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0011008
Planned Relative Time
Descripción

time relative to dose

Tipo de datos

integer

Alias
UMLS CUI [1]
C0439564
Actual time
Descripción

Actual time of specimen collection

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Sample number
Descripción

Sample number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1299222
UMLS CUI [1,2]
C0201734
PK sample taken
Descripción

PK sample taken

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
Vital Signs - Evening Dose
Descripción

Vital Signs - Evening Dose

Alias
UMLS CUI-1
C0518766
Date
Descripción

Vital Signs Assessment Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2985720
Planned Relative Time
Descripción

Planned Relative Time

Tipo de datos

integer

Alias
UMLS CUI [1]
C0439564
Actual Time
Descripción

vital signs time

Tipo de datos

time

Alias
UMLS CUI [1]
C2826762
Systolic blood pressure
Descripción

Systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Pharmacokinetic Sampling - Evening Dose
Descripción

Pharmacokinetic Sampling - Evening Dose

Alias
UMLS CUI-1
C0201734
Date
Descripción

sample date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0011008
Planned Relative Time
Descripción

time relative to dose

Tipo de datos

integer

Alias
UMLS CUI [1]
C0439564
Actual time
Descripción

Actual time of specimen collection

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Sample number
Descripción

Sample number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1299222
UMLS CUI [1,2]
C0201734
PK sample taken
Descripción

PK sample taken

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
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Similar models

Main CRF (PK Day - Treatment Period 2)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry Worksheet
C1321605 (UMLS CUI-1)
C0021822 (UMLS CUI-2)
C2347852 (UMLS CUI-4)
C0021822 (UMLS CUI-5)
C0877248 (UMLS CUI-7)
C0021822 (UMLS CUI-8)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Investigator Identifier
Item
Investigator number
integer
C2826689 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Compliance behavior
Item
Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
boolean
C1321605 (UMLS CUI [1])
Compliance behavior limited
Item
Is the subject aware of any forthcoming requirements?
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Concomitant medications
Item
Has the subject used any concomitant medications?
boolean
C2347852 (UMLS CUI [1])
Health status change
Item
Has there been any change in the state of the subject's health?
boolean
C0018759 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Eligibility
Item
Collect the Treatment Period Subject Diary Card issued on Day 1 (Treatment Period 2) and transcribe the data, as appropriate, to the INVESTIGATIONAL PRODUCT page in this CRF. Collect the study medication issued on Day 1 (Treatment Period 2). If the subject is eligible to continue in the study do the following at the end of this visit: Make an appointment for the subject to return to the clinic in 4-10 days for a Follow-up visit.
text
C0013893 (UMLS CUI [1])
Item Group
Vital Signs - Morning Dose
C0518766 (UMLS CUI-1)
Vital Signs Assessment Date
Item
Date
date
C0518766 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
5hrs (2)
CL Item
10hrs (3)
CL Item
Unscheduled (4)
vital signs time
Item
Actual Time
time
C2826762 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Pharmacokinetic Sampling - Morning Dose
C0201734 (UMLS CUI-1)
sample date
Item
Date
date
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
5mins (2)
CL Item
10mins (3)
CL Item
30mins (4)
CL Item
45mins (5)
CL Item
1 hr (6)
CL Item
1.5hrs (7)
CL Item
2hrs (8)
CL Item
3hrs (9)
CL Item
5hrs (10)
CL Item
10hrs (11)
Actual time of specimen collection
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Sample number
Item
Sample number
integer
C1299222 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
PK sample taken
Item
PK sample taken
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
Item Group
Vital Signs - Evening Dose
C0518766 (UMLS CUI-1)
Vital Signs Assessment Date
Item
Date
date
C0518766 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
3hrs (1)
CL Item
10hrs (2)
CL Item
Unscheduled (3)
vital signs time
Item
Actual Time
time
C2826762 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Pharmacokinetic Sampling - Evening Dose
C0201734 (UMLS CUI-1)
sample date
Item
Date
date
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
5mins (2)
CL Item
10mins (3)
CL Item
30mins (4)
CL Item
45mins (5)
CL Item
1 hr (6)
CL Item
1.5hrs (7)
(Comment:en)
CL Item
2hrs (8)
(Comment:en)
CL Item
3hrs (9)
(Comment:en)
CL Item
5hrs (10)
(Comment:en)
CL Item
10hrs (11)
(Comment:en)
CL Item
12hrs (12)
(Comment:en)
Actual time of specimen collection
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Sample number
Item
Sample number
integer
C1299222 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
PK sample taken
Item
PK sample taken
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
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