ID

25977

Beskrivning

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.

Nyckelord

Versioner (1)
  1. 2017-10-02 2017-10-02 -
Rättsinnehavare

Glaxo Smith Kline

Uppladdad den

2 oktober 2017

DOI

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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 1)

Engelsk

Main CRF (PK Day - Treatment Period 1)

1 Formulär  
Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry Worksheet
Beskrivning

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
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Investigator number
Beskrivning

Investigator Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2826689
Treatment Number
Beskrivning

Treatment Number

Datatyp

text

Alias
UMLS CUI [1]
C1522541
Date of assessment
Beskrivning

day month year

Datatyp

date

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

Compliance behavior

Datatyp

boolean

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

Compliance behavior limited

Datatyp

boolean

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

Comments

Datatyp

text

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

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

Datatyp

boolean

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

If YES record any adverse events as per protocol.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C0392747
Collect the Run-in Subject Diary Card issued at the Run-in visit and transcribe the data, as appropriate, to the INVESTIGATIONAL PRODUCT page in this CRF. Collect the Run-in study medication issued at the Run-in visit. If the subject is eligible to continue in the study: Issue the Treatment Period Subject Diary Card and instruct the subject how it should be completed Emphasize to the subject the importance of completing it at the required time each morning and evening. Issue study medication Make an appointment for the subject to return in 5, 6, or 7 days time, as appropriate.
Beskrivning

Eligibility

Datatyp

text

Alias
UMLS CUI [1]
C0013893
Remind the subject to bring the following to the next visit: completed Treatment Period Subject Diary Card and study medication. Not to take study medication on the morning of the next clinic visit.
Beskrivning

Reminder

Datatyp

text

Alias
UMLS CUI [1]
C1709896
Drugs of Abuse Screen / Pregnancy Test Worksheet (Pre-Dose)
Beskrivning

Drugs of Abuse Screen / Pregnancy Test Worksheet (Pre-Dose)

Alias
UMLS CUI-1
C0439565
UMLS CUI-2
C0038577
UMLS CUI-3
C0032976
Date sample taken
Beskrivning

Specimen collection

Datatyp

date

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0038577
Drug screening Positive finding
Beskrivning

If any of these are positive, EXCLUDE subject from the study.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0038577
UMLS CUI [1,2]
C1514241
Drug screening Negative finding
Beskrivning

Drug screening Negative finding

Datatyp

integer

Alias
UMLS CUI [1,1]
C0038577
UMLS CUI [1,2]
C1513916
Is a pregnancy test applicable?
Beskrivning

pregnancy test

Datatyp

boolean

Alias
UMLS CUI [1]
C0032976
If YES, was pregnancy test performed?
Beskrivning

pregnancy test

Datatyp

boolean

Alias
UMLS CUI [1]
C0032976
Pregnancy test result, tick one
Beskrivning

If positive, complete PREGNANCY NOTIFICATION FORM.

Datatyp

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Vital Signs - Morning Dose
Beskrivning

Vital Signs - Morning Dose

Alias
UMLS CUI-1
C0518766
Date
Beskrivning

Vital Signs Assessment Date

Datatyp

date

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

time relative to dosing

Datatyp

integer

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

vital signs time

Datatyp

time

Alias
UMLS CUI [1]
C2826762
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Pharmacokinetic Sampling - Morning Dose
Beskrivning

Pharmacokinetic Sampling - Morning Dose

Alias
UMLS CUI-1
C0201734
Date
Beskrivning

sample date

Datatyp

date

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

time relative to dose

Datatyp

integer

Alias
UMLS CUI [1]
C0439564
Actual time
Beskrivning

Actual time of specimen collection

Datatyp

time

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

Sample number

Datatyp

integer

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

PK sample taken

Datatyp

boolean

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

Vital Signs - Evening Dose

Alias
UMLS CUI-1
C0518766
Date
Beskrivning

Vital Signs Assessment Date

Datatyp

date

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

Planned Relative Time

Datatyp

integer

Alias
UMLS CUI [1]
C0439564
Actual Time
Beskrivning

vital signs time

Datatyp

time

Alias
UMLS CUI [1]
C2826762
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Pharmacokinetic Sampling - Evening Dose
Beskrivning

Pharmacokinetic Sampling - Evening Dose

Alias
UMLS CUI-1
C0201734
Date
Beskrivning

sample date

Datatyp

date

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

time relative to dose

Datatyp

integer

Alias
UMLS CUI [1]
C0439564
Actual time
Beskrivning

Actual time of specimen collection

Datatyp

time

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

Sample number

Datatyp

integer

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

PK sample taken

Datatyp

boolean

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

Main CRF (PK Day - Treatment Period 1)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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 Run-in Subject Diary Card issued at the Run-in visit and transcribe the data, as appropriate, to the INVESTIGATIONAL PRODUCT page in this CRF. Collect the Run-in study medication issued at the Run-in visit. If the subject is eligible to continue in the study: Issue the Treatment Period Subject Diary Card and instruct the subject how it should be completed Emphasize to the subject the importance of completing it at the required time each morning and evening. Issue study medication Make an appointment for the subject to return in 5, 6, or 7 days time, as appropriate.
text
C0013893 (UMLS CUI [1])
Reminder
Item
Remind the subject to bring the following to the next visit: completed Treatment Period Subject Diary Card and study medication. Not to take study medication on the morning of the next clinic visit.
text
C1709896 (UMLS CUI [1])
Item Group
Drugs of Abuse Screen / Pregnancy Test Worksheet (Pre-Dose)
C0439565 (UMLS CUI-1)
C0038577 (UMLS CUI-2)
C0032976 (UMLS CUI-3)
Specimen collection
Item
Date sample taken
date
C0200345 (UMLS CUI [1,1])
C0038577 (UMLS CUI [1,2])
Item
Drug screening Positive finding
integer
C0038577 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Drug screening Positive finding
Code List
Drug screening Positive finding
CL Item
Opiates (1)
CL Item
Cocaine (2)
CL Item
Barbiturates (3)
CL Item
Amphetamines (4)
CL Item
Benzod iazepines (5)
CL Item
Cannabinoids (6)
Item
Drug screening Negative finding
integer
C0038577 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Drug screening Positive finding
Code List
Drug screening Negative finding
CL Item
Opiates (1)
CL Item
Cocaine (2)
CL Item
Barbiturates (3)
CL Item
Amphetamines (4)
CL Item
Benzod iazepines (5)
CL Item
Cannabinoids (6)
pregnancy test
Item
Is a pregnancy test applicable?
boolean
C0032976 (UMLS CUI [1])
pregnancy test
Item
If YES, was pregnancy test performed?
boolean
C0032976 (UMLS CUI [1])
Item
Pregnancy test result, tick one
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Pregnancy Test Result
Code List
Pregnancy test result, tick one
CL Item
negative (N)
CL Item
positive (P)
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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