ID

33031

Beschreibung

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

Stichworte

Versionen (1)
  1. 23.11.18 23.11.18 -
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GlaxoSmithKline

Hochgeladen am

23. November 2018

DOI

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Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138

Englisch

Date of Visit/ Assessment, Unscheduled Assessments Performed, Vital signs, Candidiasis Examination, Electronically transferred lab data, Liver Events Assessment (Unscheduled); Date of Visit/ Assessment, Status of Treatment Blind, Pregnancy Information, Pharmacogenetic (PGx) Research Withdrawal of Consent, Study Conclusion, Investigator Signature (End of Study)

1 Formulare  
Date of Visit/ Assessment - Unscheduled
Beschreibung

Date of Visit/ Assessment - Unscheduled

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

Date of Visit/ Assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Unscheduled Assessments Performed
Beschreibung

Unscheduled Assessments Performed

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C3854240
Select any unscheduled assessments that were performed at this visit.
Beschreibung

Unscheduled assessments that were performed at this visit

Datentyp

integer

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C3854240
Vital signs
Beschreibung

Vital signs

Alias
UMLS CUI-1
C0518766
Actual date/ time
Beschreibung

Actual date/ time

Datentyp

datetime

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

Blood pressure

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Subject position
Beschreibung

Position must be consistent throughout the study.

Datentyp

integer

Alias
UMLS CUI [1]
C1262869
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Respiration rate
Beschreibung

Respiration rate

Datentyp

integer

Maßeinheiten
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Calculated Subject position
Beschreibung

Calculated Subject position

Datentyp

text

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

Candidiasis Examination

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

Oropharyngeal candidiasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0919659
Electronically transferred lab data
Beschreibung

Electronically transferred lab data

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

Date Sample(s) Taken

Datentyp

date

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

Haem Lab type code

Datentyp

text

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

Chem Lab type code

Datentyp

text

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

Urin Lab type code

Datentyp

text

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

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?
Beschreibung

Liver chemistry event for the lab samples collected at this visit

Datentyp

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.
Beschreibung

Specify type of liver chemistry event

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C2348235
Date of Visit/ Assessment - End of Study
Beschreibung

Date of Visit/ Assessment - End of Study

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

Date of Visit/ Assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Status of Treatment Blind
Beschreibung

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Beschreibung

Was the treatment blind broken during the study?

Datentyp

boolean

Alias
UMLS CUI [1]
C3897431
If the treatment blind was broken during the study, complete Date blind broken.
Beschreibung

Date blind broken

Datentyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Reason for treatment blind was broken
Beschreibung

Reason for treatment blind was broken

Datentyp

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
If other Reason for treatment blind was broken, specify.
Beschreibung

If other Reason for treatment blind was broken, specify.

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Pregnancy Information
Beschreibung

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Beschreibung

Did the subject become pregnant during the study?

Datentyp

boolean

Alias
UMLS CUI [1]
C3828490
Pharmacogenetic (PGx) Research Withdrawal of Consent
Beschreibung

Pharmacogenetic (PGx) Research Withdrawal of Consent

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
UMLS CUI-3
C2349954
Has the subject withdrawn consent for PGx research?
Beschreibung

Has the subject withdrawn consent for PGx research?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
Date informed consent withdrawn
Beschreibung

Date informed consent withdrawn

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0009797
Has a request been made for sample destruction?
Beschreibung

Has a request been made for sample destruction?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
If a request has been made for sample destruction, check reason.
Beschreibung

Reason for request for sample destruction

Datentyp

integer

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
If other reason for request for sample destruction, specify.
Beschreibung

If other reason for request for sample destruction, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Study Conclusion
Beschreibung

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of subject completion or withdrawal
Beschreibung

Date of subject completion or withdrawal

Datentyp

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C1549507
Was the subject withdrawn from the study?
Beschreibung

Was the subject withdrawn from the study?

Datentyp

text

Alias
UMLS CUI [1]
C0422727
Primary reason for withdrawal
Beschreibung

Primary reason for withdrawal

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Specify investigator discretion
Beschreibung

Specify investigator discretion

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0022423
UMLS CUI [1,3]
C2348235
Withdrew consent specification
Beschreibung

Withdrew consent specification

Datentyp

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2348235
Investigator Signature
Beschreibung

Investigator Signature

Alias
UMLS CUI-1
C2346576
Investigator Signature
Beschreibung

Investigator Siganture

Datentyp

text

Alias
UMLS CUI [1]
C2346576
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Ähnliche Modelle

Date of Visit/ Assessment, Unscheduled Assessments Performed, Vital signs, Candidiasis Examination, Electronically transferred lab data, Liver Events Assessment (Unscheduled); Date of Visit/ Assessment, Status of Treatment Blind, Pregnancy Information, Pharmacogenetic (PGx) Research Withdrawal of Consent, Study Conclusion, Investigator Signature (End of Study)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of Visit/ Assessment - Unscheduled
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
Unscheduled Assessments Performed
C0220825 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Item
Select any unscheduled assessments that were performed at this visit.
integer
C0220825 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Unscheduled assessments that were performed at this visit
Code List
Select any unscheduled assessments that were performed at this visit.
CL Item
Vitals (1)
CL Item
Lab (2)
CL Item
Candidiasis (3)
CL Item
Liver events assessment as a result of unscheduled chemistry lab results (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
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)
Item Group
Date of Visit/ Assessment - End of Study
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
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Was the treatment blind broken during the study?
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date blind broken
Item
If the treatment blind was broken during the study, complete Date blind broken.
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason for treatment blind was broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason for treatment blind was broken
Code List
Reason for treatment blind was broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (2)
If other Reason for treatment blind was broken, specify.
Item
If other Reason for treatment blind was broken, specify.
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C3828490 (UMLS CUI [1])
Item Group
Pharmacogenetic (PGx) Research Withdrawal of Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
Has the subject withdrawn consent for PGx research?
Item
Has the subject withdrawn consent for PGx research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Date informed consent withdrawn
Item
Date informed consent withdrawn
date
C0011008 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0009797 (UMLS CUI [1,3])
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
If a request has been made for sample destruction, check reason.
integer
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Reason for request for sample destruction
Code List
If a request has been made for sample destruction, check reason.
CL Item
Subject withdrew consent for PGx (3)
CL Item
Screen failure (2)
CL Item
Other, speciy (1)
If other reason for request for sample destruction, specify
Item
If other reason for request for sample destruction, specify.
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C0422727 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1549507 (UMLS CUI [2])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Was the subject withdrawn from the study?
Code List
Was the subject withdrawn from the study?
CL Item
No (N)
CL Item
Yes, complete the primary reason for withdrawal (Y)
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse Event (Record all details on the Non- Serious Adverse Events or Serious Adverse Events forms as approprioate) (1)
CL Item
Lack of efficacy (check all that apply. If none, select "No Subreasons") (2)
CL Item
No subreasons (99)
CL Item
Exacerbation (019)
CL Item
Exceeded rescue medication use (as defined in the protocol) (071)
CL Item
Below PEF stability limit (073)
CL Item
Below FEV1 stability limit (074)
CL Item
Asthma worsening requiring additional asthma medication (148)
CL Item
Protocol Deviation (check all that apply. If none, select "No Subreasons") (3)
CL Item
No subreasons (99)
CL Item
Pregnancy (024)
CL Item
Prohibited medication use (029)
CL Item
Subject reached protocol defined stopping criteria (4)
CL Item
Liver function test abnormality (017)
CL Item
ECG abnormality (007)
CL Item
Study closed/ terminated (5)
CL Item
Lost to Follow- up (6)
CL Item
Investigator discretion, specify (Select this reason if none of the other primary reasons are appropriate.) (7)
CL Item
Withdrew consent, specify: Select this reason if none of the other primary reasons are appropriate (8)
Specify investigator discretion
Item
Specify investigator discretion
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Withdrew consent specification
Item
Withdrew consent specification
text
C1707492 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Investigator Siganture
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
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