ID

25967

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 (2)
  1. 2/10/17 2/10/17 -
  2. 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 (Follow-up)

Inglés

Main CRF (Follow-up)

1 formularios  
  1. StudyEvent: ODM
    1. Main CRF (Follow-up)
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
Pregnancy Test Worksheet
Descripción

Pregnancy Test Worksheet

Alias
UMLS CUI-1
C0032976
Date sample taken
Descripción

Specimen collection

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0038577
Is a pregnancy test applicable?
Descripción

pregnancy test

Tipo de datos

boolean

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

pregnancy test

Tipo de datos

boolean

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

If positive, complete PREGNANCY NOTIFICATION FORM.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
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Similar models

Main CRF (Follow-up)

1 formularios
  1. StudyEvent: ODM
    1. Main CRF (Follow-up)
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])
Item Group
Pregnancy Test Worksheet
C0032976 (UMLS CUI-1)
Specimen collection
Item
Date sample taken
date
C0200345 (UMLS CUI [1,1])
C0038577 (UMLS CUI [1,2])
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)
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