ID

32994

Beschrijving

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

Trefwoorden

Versies (2)
  1. 22-11-18 22-11-18 -
  2. 23-11-18 23-11-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

22 november 2018

DOI

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Licentie

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

Engels

Date of Visit/ Assessment, Investigational Product, Vital signs, Candidiasis Examination, PK Sample, Subject Withdrawal Status, Electronically transferred lab data, Liver Events Assessment- Visit 6

1 Formulieren  
Date of Visit/ Assessment
Beschrijving

Date of Visit/ Assessment

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

Date of Visit/ Assessment

Datatype

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Investigational Product
Beschrijving

Investigational Product

Alias
UMLS CUI-1
C0304229
Previous Evening Dose Date and Time
Beschrijving

Previous Evening Dose Date and Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C1986447
UMLS CUI [1,2]
C0587117
UMLS CUI [1,3]
C0205156
Time of PM clinic visit dose
Beschrijving

Time of PM clinic visit dose

Datatype

time

Alias
UMLS CUI [1,1]
C0008952
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C1509133
Vital signs
Beschrijving

Vital signs

Alias
UMLS CUI-1
C0518766
Actual date/ time
Beschrijving

Actual date/ time

Datatype

datetime

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

Blood pressure

Datatype

text

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Subject position
Beschrijving

Position must be consistent throughout the study.

Datatype

integer

Alias
UMLS CUI [1]
C1262869
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Beschrijving

Temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Respiration rate
Beschrijving

Respiration rate

Datatype

integer

Maateenheden
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Calculated Subject position
Beschrijving

Calculated Subject position

Datatype

text

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

Candidiasis Examination

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

Oropharyngeal candidiasis

Datatype

boolean

Alias
UMLS CUI [1]
C0919659
PK Sample - Pre Dose
Beschrijving

PK Sample - Pre Dose

Alias
UMLS CUI-1
C1277698
UMLS CUI-2
C0031327
PK Sample taken?
Beschrijving

PK Sample taken?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
If PK sample was taken, complete actual start time.
Beschrijving

If PK sample was taken, complete actual start time

Datatype

datetime

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
UMLS CUI [1,3]
C1301880
PK Sample PK Sample - 15 Minutes Post- Dose
Beschrijving

PK Sample PK Sample - 15 Minutes Post- Dose

Alias
UMLS CUI-1
C1277698
UMLS CUI-2
C0031327
PK Sample taken?
Beschrijving

PK Sample taken?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
If PK sample was taken, complete actual start time.
Beschrijving

If PK sample was taken, complete actual start time

Datatype

datetime

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
UMLS CUI [1,3]
C1301880
PK Sample PK Sample - 1.5 HoursPost- Dose
Beschrijving

PK Sample PK Sample - 1.5 HoursPost- Dose

Alias
UMLS CUI-1
C1277698
UMLS CUI-2
C0031327
PK Sample taken?
Beschrijving

PK Sample taken?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
If PK sample was taken, complete actual start time.
Beschrijving

If PK sample was taken, complete actual start time

Datatype

datetime

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
UMLS CUI [1,3]
C1301880
Subject Withdrawal Status
Beschrijving

Subject Withdrawal Status

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

Did the subject withdraw at this visit?

Datatype

boolean

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

Electronically transferred lab data

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

Date Sample(s) Taken

Datatype

date

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

Haem Lab type code

Datatype

text

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

Chem Lab type code

Datatype

text

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

Urin Lab type code

Datatype

text

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

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?
Beschrijving

Liver chemistry event for the lab samples collected at this visit

Datatype

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.
Beschrijving

Specify type of liver chemistry event

Datatype

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, Investigational Product, Vital signs, Candidiasis Examination, PK Sample, Subject Withdrawal Status, Electronically transferred lab data, Liver Events Assessment- Visit 6

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Investigational Product
C0304229 (UMLS CUI-1)
Previous Evening Dose Date and Time
Item
Previous Evening Dose Date and Time
datetime
C1986447 (UMLS CUI [1,1])
C0587117 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Time of PM clinic visit dose
Item
Time of PM clinic visit dose
time
C0008952 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1509133 (UMLS CUI [1,4])
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
PK Sample - Pre Dose
C1277698 (UMLS CUI-1)
C0031327 (UMLS CUI-2)
PK Sample taken?
Item
PK Sample taken?
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
If PK sample was taken, complete actual start time
Item
If PK sample was taken, complete actual start time.
datetime
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item Group
PK Sample PK Sample - 15 Minutes Post- Dose
C1277698 (UMLS CUI-1)
C0031327 (UMLS CUI-2)
PK Sample taken?
Item
PK Sample taken?
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
If PK sample was taken, complete actual start time
Item
If PK sample was taken, complete actual start time.
datetime
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item Group
PK Sample PK Sample - 1.5 HoursPost- Dose
C1277698 (UMLS CUI-1)
C0031327 (UMLS CUI-2)
PK Sample taken?
Item
PK Sample taken?
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
If PK sample was taken, complete actual start time
Item
If PK sample was taken, complete actual start time.
datetime
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
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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