ID

33023

Descripción

Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

Palabras clave

Versiones (2)
  1. 21/11/18 21/11/18 -
  2. 23/11/18 23/11/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

23 de noviembre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138

Inglés

Date of Visit/ Assessment, Vital signs, Candidiasis Examination, Inhaler Ease Of Use Assessment,Device Use Assessment, Subject Withdrawal Status, Electronically transferred lab data, Liver Events Assessment - Visit 5

1 formularios  
Date of Visit/ Assessment
Descripción

Date of Visit/ Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of Visit/ Assessment
Descripción

Date of Visit/ Assessment

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Vital signs
Descripción

Vital signs

Alias
UMLS CUI-1
C0518766
Actual date/ time
Descripción

Actual date/ time

Tipo de datos

datetime

Alias
UMLS CUI [1]
C1264639
Blood pressure (systolic/ diastolic)
Descripción

Blood pressure

Tipo de datos

text

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Subject position
Descripción

Position must be consistent throughout the study.

Tipo de datos

integer

Alias
UMLS CUI [1]
C1262869
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Descripción

Temperature

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Respiration rate
Descripción

Respiration rate

Tipo de datos

integer

Unidades de medida
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Calculated Subject position
Descripción

Calculated Subject position

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0444686
Candidiasis Examination
Descripción

Candidiasis Examination

Alias
UMLS CUI-1
C0006840
UMLS CUI-2
C4321457
Does the subject have clinical visual evidence of oropharyngeal candidiasis?
Descripción

Oropharyngeal candidiasis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0919659
Inhaler Ease Of Use Assessment
Descripción

Inhaler Ease Of Use Assessment

Alias
UMLS CUI-1
C1272700
UMLS CUI-2
C0021461
UMLS CUI-3
C1524063
UMLS CUI-4
C0220825
How do you rate the ease of use of the inhaler?
Descripción

Ease of use of the inhaler

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1272700
UMLS CUI [1,2]
C0021461
UMLS CUI [1,3]
C1524063
How easily are you able to tell how many doses of medication are left in the inhaler?
Descripción

How easily are you able to tell how many doses of medication are left in the inhaler?

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1272700
UMLS CUI [1,2]
C2364293
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0750480
UMLS CUI [2,3]
C0021461
Device Use Assessment
Descripción

Device Use Assessment

Alias
UMLS CUI-1
C0699733
UMLS CUI-2
C1524063
UMLS CUI-3
C0220825
Did the subject use the device correctly?
Descripción

Did the subject use the device correctly?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0699733
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C2349182
If subject does not use the device correctly, what did subject do incorrectly? ´
Descripción

If subject does not use the device correctly, what did subject do incorrectly?

Tipo de datos

integer

Alias
UMLS CUI [1]
C3544346
If subject does not use the device correctly, record number of times subject required additional instruction.
Descripción

Number of times subject required additional instruction

Tipo de datos

integer

Alias
UMLS CUI [1]
C3544346
UMLS CUI [2,1]
C1442085
UMLS CUI [2,2]
C1524062
UMLS CUI [2,3]
C0237753
Subject Withdrawal Status
Descripción

Subject Withdrawal Status

Alias
UMLS CUI-1
C0422727
UMLS CUI-2
C0449438
Did the subject withdraw at this visit?
Descripción

Did the subject withdraw at this visit?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1710677
UMLS CUI [2]
C0545082
Electronically transferred lab data
Descripción

Electronically transferred lab data

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C1320722
Date Sample(s) Taken
Descripción

Date Sample(s) Taken

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
Haem Lab type code
Descripción

Haem Lab type code

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
Chem Lab type code
Descripción

Chem Lab type code

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0005774
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
Urin Lab type code
Descripción

Urin Lab type code

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
Liver Events Assessment
Descripción

Liver Events Assessment

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
Descripción

Liver chemistry event for the lab samples collected at this visit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0877248
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0545082
Specify type of liver chemistry event.
Descripción

Specify type of liver chemistry event

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C2348235
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Similar models

Date of Visit/ Assessment, Vital signs, Candidiasis Examination, Inhaler Ease Of Use Assessment,Device Use Assessment, Subject Withdrawal Status, Electronically transferred lab data, Liver Events Assessment - Visit 5

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Actual date/ time
Item
Actual date/ time
datetime
C1264639 (UMLS CUI [1])
Blood pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1])
Subject position
Code List
Subject position
CL Item
Supine  (1)
CL Item
Sitting  (2)
CL Item
Standing  (3)
CL Item
Semi- supine (4)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Calculated Subject position
Item
Calculated Subject position
text
C1262869 (UMLS CUI [1,1])
C0444686 (UMLS CUI [1,2])
Item Group
Candidiasis Examination
C0006840 (UMLS CUI-1)
C4321457 (UMLS CUI-2)
Oropharyngeal candidiasis
Item
Does the subject have clinical visual evidence of oropharyngeal candidiasis?
boolean
C0919659 (UMLS CUI [1])
Item Group
Inhaler Ease Of Use Assessment
C1272700 (UMLS CUI-1)
C0021461 (UMLS CUI-2)
C1524063 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
Item
How do you rate the ease of use of the inhaler?
integer
C1272700 (UMLS CUI [1,1])
C0021461 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
ease of use of the inhaler
Code List
How do you rate the ease of use of the inhaler?
CL Item
Very easy (1)
CL Item
Easy (2)
CL Item
Neutral (3)
CL Item
Difficult (4)
CL Item
Very Difficult (5)
Item
How easily are you able to tell how many doses of medication are left in the inhaler?
integer
C1272700 (UMLS CUI [1,1])
C2364293 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
C0021461 (UMLS CUI [2,3])
undefined item
Code List
How easily are you able to tell how many doses of medication are left in the inhaler?
CL Item
Very easy (1)
CL Item
Easy (2)
CL Item
Neutral (3)
CL Item
Difficult (4)
CL Item
Very difficult (5)
Item Group
Device Use Assessment
C0699733 (UMLS CUI-1)
C1524063 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Did the subject use the device correctly?
Item
Did the subject use the device correctly?
boolean
C0699733 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C2349182 (UMLS CUI [1,3])
Item
If subject does not use the device correctly, what did subject do incorrectly? ´
integer
C3544346 (UMLS CUI [1])
If subject does not use the device correctly, what did subject do incorrectly?
Code List
If subject does not use the device correctly, what did subject do incorrectly? ´
CL Item
Open the device  (1)
CL Item
Inhale the device (2)
CL Item
Close the device (3)
Item
If subject does not use the device correctly, record number of times subject required additional instruction.
integer
C3544346 (UMLS CUI [1])
C1442085 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0237753 (UMLS CUI [2,3])
Number of times subject required additional instruction
Code List
If subject does not use the device correctly, record number of times subject required additional instruction.
CL Item
1  (1)
CL Item
2  (2)
CL Item
3  (3)
CL Item
>3 (4)
Item Group
Subject Withdrawal Status
C0422727 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Did the subject withdraw at this visit?
Item
Did the subject withdraw at this visit?
boolean
C1710677 (UMLS CUI [1])
C0545082 (UMLS CUI [2])
Item Group
Electronically transferred lab data
C0022885 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
Date Sample(s) Taken
Item
Date Sample(s) Taken
date
C1302413 (UMLS CUI [1])
Haem Lab type code
Item
Haem Lab type code
text
C0018941 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Chem Lab type code
Item
Chem Lab type code
text
C0005774 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Urin Lab type code
Item
Urin Lab type code
text
C0042014 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Item Group
Liver Events Assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Liver chemistry event for the lab samples collected at this visit
Item
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
boolean
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0005834 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
Item
Specify type of liver chemistry event.
integer
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Specify type of liver chemistry event
Code List
Specify type of liver chemistry event.
CL Item
Liver Event Monitoring Criteria (subject has met protocol defined liver event monitoring criteria). Obtain tests as per protocol. (1)
CL Item
Liver Event Stopping Criteria (subject has met protocol defined liver event stopping criteria, has been monitored for the protocol specified time period and continues to meet liver chemistry monitoring criteria). Stop investigational product, complete date stopped on Investigational Product Form and contact GSK within 24 hours of occurence of liver event by phone or fax. NOTE: If the liver event meets the definition of an SAE, the SAE form must be completed in InForm. If InForm is unavailable, the SAE form should be faxed to GSK. (2)
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