ID

29546

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: Period 1

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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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

Period 1

1 Formulare  
  1. StudyEvent: ODM
    1. Period 1
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
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C0304229
Investigational Product Date of Dose
Beschreibung

Investigational Product Date of Dose

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011008
Investigational Product Time of Dose
Beschreibung

Investigational Product Time of Dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Did the subject receive the correct treatment (e.g., treatment which the subject [Y] Q Yes was assigned to) during this dosing interval?
Beschreibung

correct treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
No, record reason(s)
Beschreibung

reason correct treatment not recieved

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0392360
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Investigational Product Date of Dose
Beschreibung

Investigational Product Date of Dose

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011008
Investigational Product Time of Dose
Beschreibung

Investigational Product Time of Dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Timepoint of measurement Vital Signs
Beschreibung

Timepoint of measurement Vital Signs

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2348792
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
Investigational Product Date of Dose
Beschreibung

Investigational Product Date of Dose

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011008
Investigational Product Time of Dose
Beschreibung

Investigational Product Time of Dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Timepoint of measurement ECG
Beschreibung

Timepoint of measurement ECG

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2348792
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
Pharmacokinetics Blood
Beschreibung

Pharmacokinetics Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0304229
Investigational Product Date of Dose
Beschreibung

Investigational Product Date of Dose

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011008
Investigational Product Time of Dose
Beschreibung

Investigational Product Time of Dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Timepoint Pharmacokinetics
Beschreibung

Timepoint Pharmacokinetics

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C2348792
Actual time Pharmacokinetics
Beschreibung

Actual time Pharmacokinetics

Datentyp

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
Electronically Transferred Lab Data (24hrs)
Beschreibung

Electronically Transferred Lab Data (24hrs)

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
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Ähnliche Modelle

Period 1

1 Formulare
  1. StudyEvent: ODM
    1. Period 1
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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
Investigational Product
C0304229 (UMLS CUI-1)
Investigational Product Date of Dose
Item
Investigational Product Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigational Product Time of Dose
Item
Investigational Product Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
correct treatment
Item
Did the subject receive the correct treatment (e.g., treatment which the subject [Y] Q Yes was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1])
reason correct treatment not recieved
Item
No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Investigational Product Date of Dose
Item
Investigational Product Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigational Product Time of Dose
Item
Investigational Product Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Timepoint of measurement Vital Signs
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Number of measurement
Code List
Timepoint of measurement Vital Signs
CL Item
Pre-dose 1 (1)
CL Item
Pre-dose 2 (2)
CL Item
Pre-dose 3 (3)
CL Item
15 mins (4)
CL Item
30 mins (5)
CL Item
45 mins (6)
CL Item
1 hr (7)
CL Item
1,5 hr (8)
CL Item
2 hr (9)
CL Item
4 hr (10)
CL Item
8 hr (11)
CL Item
12 hr (12)
CL Item
24 hr (13)
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)
Investigational Product Date of Dose
Item
Investigational Product Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigational Product Time of Dose
Item
Investigational Product Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Timepoint of measurement ECG
integer
C0430456 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Number of measurement
Code List
Timepoint of measurement ECG
CL Item
Pre-dose 1 (1)
CL Item
Pre-dose 2 (2)
CL Item
Pre-dose 3 (3)
CL Item
15 mins (4)
CL Item
30 mins (5)
CL Item
45 mins (6)
CL Item
1 hr (7)
CL Item
1,5 hr (8)
CL Item
2 hr (9)
CL Item
8 hr (10)
CL Item
12 hr (11)
CL Item
24 hr (12)
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
Pharmacokinetics Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Investigational Product Date of Dose
Item
Investigational Product Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigational Product Time of Dose
Item
Investigational Product Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Timepoint Pharmacokinetics
integer
C0031328 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Timepoint Pharmacokinetics
Code List
Timepoint Pharmacokinetics
CL Item
Pre-dose 1 (1)
CL Item
5 mins (2)
CL Item
10 mins (3)
CL Item
20 mins (4)
CL Item
30 mins (5)
CL Item
45 mins (6)
CL Item
1 hr (7)
CL Item
1,5 hr (8)
CL Item
2 hr (9)
CL Item
3 hrs (10)
CL Item
4 hrs (11)
CL Item
6 hrs (12)
CL Item
8 hrs (13)
CL Item
10 hrs (14)
CL Item
12 hrs (15)
CL Item
24 hrs (16)
CL Item
32 hrs (17)
CL Item
48 hrs (18)
Actual time Pharmacokinetics
Item
Actual time Pharmacokinetics
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically Transferred Lab Data (24hrs)
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])
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