ID

29549

Beskrivning

Study ID: 102932 Clinical Study ID: HZA102932 Study Title:An open-label, randomised, 3-way crossover single dose study to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) when administered as FF/VI inhalation powder from the novel dry powder inhaler in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01213849 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma Documentation part: Follow-up

Nyckelord

Versioner (2)
  1. 2018-03-10 2018-03-10 -
  2. 2018-04-05 2018-04-05 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

5 april 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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GSK Dose proportionality of fluticasone furoate and equivalence of vilanterol in healthy adults NCT01213849

Engelsk

Follow-up

1 Formulär  
  1. StudyEvent: ODM
    1. Follow-up
Study Conclusion
Beskrivning

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of visit/assessment
Beskrivning

Date of visit/assessment

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Date of last contact
Beskrivning

Date of last contact

Datatyp

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Beskrivning

subject withdrawn from the study

Datatyp

boolean

Alias
UMLS CUI [1]
C0422727
Yes, complete details : Date of decision to withdraw
Beskrivning

Date of decision to withdraw

Datatyp

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Yes, complete details: Primary reason for withdrawal
Beskrivning

Primary reason for withdrawal

Datatyp

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Case book ready for signature?
Beskrivning

Case book ready for signature

Datatyp

boolean

Alias
UMLS CUI [1]
C2346576
Electronically Transferred Lab Data (D-1 Lab)
Beskrivning

Electronically Transferred Lab Data (D-1 Lab)

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
Haematology sample taken?
Beskrivning

Haematology sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C1277698
Date Haematology sample taken
Beskrivning

Date Haematology sample taken

Datatyp

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C1302413
Time Haematology sample taken
Beskrivning

Time Haematology sample taken

Datatyp

time

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0040223
Clinical Chemistry Sample taken?
Beskrivning

Clinical Chemistry Sample taken

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
Clinical Chemistry Sample same as the Haematology sample?
Beskrivning

Clinical Chemistry Sample same as the Haematology sample

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
Date Clinical Chemistry Sample taken
Beskrivning

Date Clinical Chemistry Sample taken

Datatyp

date

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0011008
Time Clinical Chemistry Sample taken
Beskrivning

Time Clinical Chemistry Sample taken

Datatyp

time

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0040223
Urinalysis done?
Beskrivning

Urinalysis done

Datatyp

boolean

Alias
UMLS CUI [1]
C0042014
Date Urinalysis sample taken
Beskrivning

Date Urinalysis sample taken

Datatyp

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
Time Urinalysis sample taken
Beskrivning

Time Urinalysis sample taken

Datatyp

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0040223
Vital Signs
Beskrivning

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date
Beskrivning

Actual date

Datatyp

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Actual time
Beskrivning

Actual time

Datatyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Blood pressure systolic
Beskrivning

Blood pressure systolic

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Beskrivning

Blood pressure diastolic

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
12-lead ECG
Beskrivning

12-lead ECG

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C0430456
Date of ECG
Beskrivning

Date of ECG

Datatyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Time of ECG
Beskrivning

Time of ECG

Datatyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0040223
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0430456
beats/min
PR Interval
Beskrivning

PR Interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C0430456
msec
QTcF Interval
Beskrivning

QTcF Interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C1882513
msec
Method of QTc Calculation
Beskrivning

Method of QTc Calculation

Datatyp

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
QTcB (Bazett)
Beskrivning

QTcB (Bazett)

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0855331
msec
Result of the ECG
Beskrivning

Result of the ECG

Datatyp

integer

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0430456
Pregnancy information
Beskrivning

Pregnancy information

Alias
UMLS CUI-1
C0032961
Did the subject become pregnant since last visit?
Beskrivning

If yes, please complete the paper Pregnancy Notification form.

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
Did a female partner of the male subject become pregnant during the study?
Beskrivning

female partner of the male subject become pregnant

Datatyp

text

Alias
UMLS CUI [1]
C0919624
Tillbaka till toppen

Similar models

Follow-up

1 Formulär
  1. StudyEvent: ODM
    1. Follow-up
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
subject withdrawn from the study
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Date of decision to withdraw
Item
Yes, complete details : Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Yes, complete details: Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
Yes, complete details: Primary reason for withdrawal
CL Item
Adverse Event, Record details on the Non·Serious Adverse Events or Serious Adverse Events forms as appropriate. (1)
CL Item
Protocol deviation (2)
CL Item
Study closed/terminated (3)
CL Item
Lost to Follow-up (4)
CL Item
Wlthdrew consent (5)
Case book ready for signature
Item
Case book ready for signature?
boolean
C2346576 (UMLS CUI [1])
Item Group
Electronically Transferred Lab Data (D-1 Lab)
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Haematology sample taken
Item
Haematology sample taken?
boolean
C1277698 (UMLS CUI [1])
Date Haematology sample taken
Item
Date Haematology sample taken
date
C1277698 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Time Haematology sample taken
Item
Time Haematology sample taken
time
C1277698 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Clinical Chemistry Sample taken
Item
Clinical Chemistry Sample taken?
boolean
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Clinical Chemistry Sample same as the Haematology sample
Item
Clinical Chemistry Sample same as the Haematology sample?
boolean
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Date Clinical Chemistry Sample taken
Item
Date Clinical Chemistry Sample taken
date
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time Clinical Chemistry Sample taken
Item
Time Clinical Chemistry Sample taken
time
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Urinalysis done
Item
Urinalysis done?
boolean
C0042014 (UMLS CUI [1])
Date Urinalysis sample taken
Item
Date Urinalysis sample taken
date
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time Urinalysis sample taken
Item
Time Urinalysis sample taken
time
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Actual date
Item
Actual date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Actual time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood pressure systolic
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
12-lead ECG
C1623258 (UMLS CUI-1)
C0430456 (UMLS CUI-2)
Date of ECG
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QTcF Interval
Item
QTcF Interval
float
C0855331 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation
CL Item
Machine; record QTc value(s) generated by the machine (1)
QTcB (Bazett)
Item
QTcB (Bazett)
float
C1882512 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal, Not clinically significant (2)
CL Item
Abnormal, Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form If the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
Pregnancy
Item
Did the subject become pregnant since last visit?
boolean
C0032961 (UMLS CUI [1])
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1])
female partner of the male subject become pregnant
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not applicable (X)
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