ID

25965

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. 10/2/17 10/2/17 -
Copyright Holder

Glaxo Smith Kline

Uploaded on

October 2, 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. Main CRF (Run-in Visit)

English

Main CRF (Run-in Visit)

1 forms  
Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry Worksheet
Description

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
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Investigator number
Description

Investigator Identifier

Data type

integer

Alias
UMLS CUI [1]
C2826689
Treatment Number
Description

Treatment Number

Data type

text

Alias
UMLS CUI [1]
C1522541
Date of assessment
Description

day month year

Data type

date

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

Compliance behavior

Data type

boolean

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

Compliance behavior limited

Data type

boolean

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

Comments

Data type

text

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

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

Data type

boolean

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

If YES record any adverse events as per protocol.

Data type

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C0392747
Drugs of Abuse Screen / Pregnancy Test Worksheet
Description

Drugs of Abuse Screen / Pregnancy Test Worksheet

Alias
UMLS CUI-1
C0038577
UMLS CUI-2
C0032976
Date sample taken
Description

Specimen collection

Data type

date

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

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

Data type

integer

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

Drug screening Negative finding

Data type

integer

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

pregnancy test

Data type

boolean

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

pregnancy test

Data type

boolean

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

Pregnancy Test Result

Data type

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
If the subject is eligible to enter the study,provide the subject with training on the correct use of the inhalers and verify that the subject can use them correctly. Issue Run-in study medication. Issue the Run-in 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. Make an appointment for the subject to return in 2 weeks time.
Description

Eligibility

Data type

text

Alias
UMLS CUI [1]
C0013893
Remind the subject to bring the following to the next visit: completed Run-in Subject Diary Card and Run-in study medication
Description

Reminder

Data type

text

Alias
UMLS CUI [1]
C1709896
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Similar models

Main CRF (Run-in Visit)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Item Group
Drugs of Abuse Screen / Pregnancy Test Worksheet
C0038577 (UMLS CUI-1)
C0032976 (UMLS CUI-2)
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)
Eligibility
Item
If the subject is eligible to enter the study,provide the subject with training on the correct use of the inhalers and verify that the subject can use them correctly. Issue Run-in study medication. Issue the Run-in 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. Make an appointment for the subject to return in 2 weeks time.
text
C0013893 (UMLS CUI [1])
Reminder
Item
Remind the subject to bring the following to the next visit: completed Run-in Subject Diary Card and Run-in study medication
text
C1709896 (UMLS CUI [1])
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