ID

29549

Beschreibung

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

Stichworte

Versionen (2)
  1. 10.03.18 10.03.18 -
  2. 05.04.18 05.04.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. April 2018

DOI

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Lizenz

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

Englisch

Follow-up

1 Formulare  
  1. StudyEvent: ODM
    1. Follow-up
Study Conclusion
Beschreibung

Study Conclusion

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

Date of visit/assessment

Datentyp

date

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

Date of last contact

Datentyp

date

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Was the subject withdrawn from the study?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

subject withdrawn from the study

Datentyp

boolean

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

Date of decision to withdraw

Datentyp

date

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

Primary reason for withdrawal

Datentyp

integer

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

Case book ready for signature

Datentyp

boolean

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

Electronically Transferred Lab Data (D-1 Lab)

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

Haematology sample taken

Datentyp

boolean

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

Date Haematology sample taken

Datentyp

date

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

Time Haematology sample taken

Datentyp

time

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

Clinical Chemistry Sample taken

Datentyp

boolean

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

Clinical Chemistry Sample same as the Haematology sample

Datentyp

boolean

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

Date Clinical Chemistry Sample taken

Datentyp

date

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

Time Clinical Chemistry Sample taken

Datentyp

time

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

Urinalysis done

Datentyp

boolean

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

Date Urinalysis sample taken

Datentyp

date

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

Time Urinalysis sample taken

Datentyp

time

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date
Beschreibung

Actual date

Datentyp

date

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

Actual time

Datentyp

time

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

Blood pressure systolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Beschreibung

Blood pressure diastolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
12-lead ECG
Beschreibung

12-lead ECG

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

Date of ECG

Datentyp

date

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

Time of ECG

Datentyp

time

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

Heart rate

Datentyp

integer

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

PR Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beschreibung

QRS Duration

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C0430456
msec
QTcF Interval
Beschreibung

QTcF Interval

Datentyp

float

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

Method of QTc Calculation

Datentyp

integer

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

QTcB (Bazett)

Datentyp

float

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

Result of the ECG

Datentyp

integer

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

Pregnancy information

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

If yes, please complete the paper Pregnancy Notification form.

Datentyp

boolean

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

female partner of the male subject become pregnant

Datentyp

text

Alias
UMLS CUI [1]
C0919624
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Ähnliche Modelle

Follow-up

1 Formulare
  1. StudyEvent: ODM
    1. Follow-up
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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