ID

25971

Descrição

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.

Palavras-chave

Versões (1)
  1. 02/10/2017 02/10/2017 -
Titular dos direitos

Glaxo Smith Kline

Transferido a

2 de outubro de 2017

DOI

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Licença

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 (Day 1- Treatment Period 1)

Inglês

Main CRF (Day 1- Treatment Period 1)

1 Formulários  
Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry Worksheet
Descrição

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
Descrição

Subject number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Investigator number
Descrição

Investigator Identifier

Tipo de dados

integer

Alias
UMLS CUI [1]
C2826689
Treatment Number
Descrição

Treatment Number

Tipo de dados

text

Alias
UMLS CUI [1]
C1522541
Date of assessment
Descrição

day month year

Tipo de dados

date

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

Compliance behavior

Tipo de dados

boolean

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

Compliance behavior limited

Tipo de dados

boolean

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

Comments

Tipo de dados

text

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

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

Tipo de dados

boolean

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

If YES record any adverse events as per protocol.

Tipo de dados

boolean

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

Drugs of Abuse Screen / Pregnancy Test Worksheet

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

Specimen collection

Tipo de dados

date

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

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

Tipo de dados

integer

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

Drug screening Negative finding

Tipo de dados

integer

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

pregnancy test

Tipo de dados

boolean

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

pregnancy test

Tipo de dados

boolean

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

If positive, complete PREGNANCY NOTIFICATION FORM.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
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.
Descrição

Eligibility

Tipo de dados

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.
Descrição

Reminder

Tipo de dados

text

Alias
UMLS CUI [1]
C1709896
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Similar models

Main CRF (Day 1- Treatment Period 1)

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
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])
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