ID

29677

Beschrijving

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Screening Part 4 - ECG and Pulmonary function parts Exhaled nitric oxide and AMP Challenge.

Link

https://clinicaltrials.gov/ct2/show/NCT00318630

Trefwoorden

Versies (2)
  1. 10-04-18 10-04-18 - Sarah Riepenhausen
  2. 10-04-18 10-04-18 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

10 april 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

Engels

Screening Part 4 - ECG and Pulmonary function (exhaled nitric oxide and AMP Challenge)

1 Formulieren  
12-Lead ECG
Beschrijving

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG number
Beschrijving

Three ECG strips more than 1 minute apart will be recorded (scheduled). Unscheduled ECGs are possible, too.

Datatype

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0237753
Start Date of ECG
Beschrijving

Start Date of ECG

Datatype

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time
Beschrijving

Planned Relative Time

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
Start Time of ECG
Beschrijving

Start Time of ECG

Datatype

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Ventricular rate
Beschrijving

Ventricular rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C2189285
beats/min
PR interval
Beschrijving

PR interval

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS duration
Beschrijving

QRS duration

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
Uncorrected QT interval
Beschrijving

Uncorrected QT interval

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
UMLS CUI [1,3]
C4072785
msec
QTc interval
Beschrijving

QTc interval

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0855331
msec
Result of ECG
Beschrijving

Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.

Datatype

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0456984
Exhaled nitric oxide
Beschrijving

Exhaled nitric oxide

Alias
UMLS CUI-1
C3700245
Exhaled nitric oxide - Date
Beschrijving

Exhaled nitric oxide - Date

Datatype

date

Alias
UMLS CUI [1,1]
C3700245
UMLS CUI [1,2]
C0011008
Planned relative time
Beschrijving

Planned relative time

Datatype

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C3700245
Actual Time of First Reading
Beschrijving

Actual Time of First Reading

Datatype

time

Alias
UMLS CUI [1,1]
C3700245
UMLS CUI [1,2]
C0040223
Reading 1
Beschrijving

Reading 1

Datatype

float

Maateenheden
  • ppb
Alias
UMLS CUI [1,1]
C3700245
UMLS CUI [1,2]
C0456984
ppb
Reading 2
Beschrijving

Reading 2

Datatype

float

Maateenheden
  • ppb
Alias
UMLS CUI [1,1]
C3700245
UMLS CUI [1,2]
C0456984
ppb
Reading 3
Beschrijving

Reading 3

Datatype

float

Maateenheden
  • ppb
Alias
UMLS CUI [1,1]
C3700245
UMLS CUI [1,2]
C0456984
ppb
Pulmonary function tests / FEV 1
Beschrijving

Pulmonary function tests / FEV 1

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C0429706
Date of FEV1
Beschrijving

Date of FEV1

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0429706
Planned Relative Time
Beschrijving

Time relative to dosing

Datatype

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0748133
Pulmonary Function Time
Beschrijving

Pulmonary Function Time

Datatype

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0024119
FEV1 Reading 1
Beschrijving

FEV1 Reading 1

Datatype

float

Maateenheden
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
FEV1 Reading 2
Beschrijving

FEV1 Reading 2

Datatype

float

Maateenheden
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
FEV1 Reading 3
Beschrijving

FEV1 Reading 3

Datatype

float

Maateenheden
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
FEV1 Reading 1
Beschrijving

Value A in investigator Calculation

Datatype

float

Maateenheden
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
FEV1 predicted normal
Beschrijving

Value B in Investigator Calculation

Datatype

float

Maateenheden
  • L
Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0086715
L
FEV1 percent predicted normal
Beschrijving

Investigator Calculation: A / B x 100 FEV1 must be > 70% of predicted at Screening.

Datatype

float

Maateenheden
  • %
Alias
UMLS CUI [1]
C0730561
%
Pulmonary function tests: Pre-AMP Challenge
Beschrijving

Pulmonary function tests: Pre-AMP Challenge

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C1096479
UMLS CUI-3
C3812758
pre-AMP pulmonary function test date
Beschrijving

pre-AMP pulmonary function test date

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0024119
UMLS CUI [1,3]
C1096479
UMLS CUI [1,4]
C3812758
Planned relative Time
Beschrijving

Time relative to start of challenge. 3 pre-saline measurements are required.

Datatype

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0748133
Time of FEV1
Beschrijving

Time of FEV1

Datatype

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0429706
FEV1 Reading
Beschrijving

FEV1 Reading

Datatype

float

Maateenheden
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
Pulmonary function tests: AMP Challenge
Beschrijving

Pulmonary function tests: AMP Challenge

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C1096479
AMP-Challenge Date
Beschrijving

AMP-Challenge Date

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1096479
Inhaled Substance
Beschrijving

Inhaled Substance

Datatype

text

Alias
UMLS CUI [1,1]
C0205535
UMLS CUI [1,2]
C0001465
UMLS CUI [2,1]
C0205535
UMLS CUI [2,2]
C0036082
Challenge Concentration (New subjects)
Beschrijving

Following the baseline assessment in which FEV1 is measured after inhalation of saline, subjects are to inhale doubling increments of AMP until a ≥20percent fall in FEV1 from the baseline saline value is achieved. 0.000 is the concentration value for saline.

Datatype

text

Maateenheden
  • mg/mL
Alias
UMLS CUI [1,1]
C1446561
UMLS CUI [1,2]
C0001465
Challenge Concentration (Historical concentration)
Beschrijving

Use this item, if historical concentrations instead of the concentrations given in the item "challenge concentration (New Subjects)" are used. Following the baseline assessment in which FEV1 is measured after inhalation of saline, subjects are to inhale doubling increments of AMP until a ≥20percent fall in FEV1 from the baseline saline value is achieved. Use 0.000 for saline inhaltation.

Datatype

float

Maateenheden
  • mg/mL
Alias
UMLS CUI [1,1]
C1446561
UMLS CUI [1,2]
C0001465
mg/mL
Start Time of Inhalation
Beschrijving

Fill in only for saline inhalation.

Datatype

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0001559
Stop Time of Inhalation
Beschrijving

Stop Time of Inhalation

Datatype

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0001559
Planned relative Time of FEV1
Beschrijving

Both timepoints must be filled after each inhalation. Time relative to stop time of inhalation.

Datatype

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0205535
UMLS CUI [1,3]
C0748133
Pulmonary function time
Beschrijving

Pulmonary function time

Datatype

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0429706
FEV1 Result
Beschrijving

FEV1 Result

Datatype

float

Maateenheden
  • L
Alias
UMLS CUI [1,1]
C0429706
UMLS CUI [1,2]
C1096479
L
Pulmonary function tests: Post-AMP Challenge
Beschrijving

Pulmonary function tests: Post-AMP Challenge

Alias
UMLS CUI-1
C0231921
UMLS CUI-2
C1096479
UMLS CUI-3
C0439568
Date of post-challenge FEV1
Beschrijving

Date of post-challenge FEV1

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0429706
UMLS CUI [1,3]
C0439568
Time of post-challenge FEV1
Beschrijving

Time relative to end of challenge: Post-challenge 6 measurements are required.

Datatype

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0429706
UMLS CUI [1,3]
C0439568
Result of post-challenge FEV1
Beschrijving

Record use of rescue Salbutamol on the Concomitant Medications page.

Datatype

float

Maateenheden
  • L
Alias
UMLS CUI [1,1]
C0429706
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0439568
L
PC20 (AMP Challenge)
Beschrijving

PC20 (AMP Challenge)

Alias
UMLS CUI-1
C1446561
UMLS CUI-2
C0001465
UMLS CUI-3
C0429706
UMLS CUI-4
C0547047
Date of challenge
Beschrijving

Date of challenge

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1096479
PC20
Beschrijving

Provocative concentration resulting in a 20% reduction in FEV1.

Datatype

float

Maateenheden
  • mg/mL
Alias
UMLS CUI [1,1]
C1446561
UMLS CUI [1,2]
C0001465
UMLS CUI [2,1]
C0429706
UMLS CUI [2,2]
C0547047
mg/mL
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Similar models

Screening Part 4 - ECG and Pulmonary function (exhaled nitric oxide and AMP Challenge)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
ECG number
text
C1623258 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
ECG number
Code List
ECG number
CL Item
ECG1 (ECG1)
CL Item
ECG2 (ECG2)
CL Item
ECG3 (ECG3)
CL Item
ECG4 (ECG4)
CL Item
ECG5 (ECG5)
CL Item
ECG6 (ECG6)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
screening (screening)
CL Item
unscheduled (unscheduled)
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Ventricular rate
Item
Ventricular rate
integer
C2189285 (UMLS CUI [1])
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
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
C4072785 (UMLS CUI [1,3])
QTc interval
Item
QTc interval
float
C0855331 (UMLS CUI [1])
Item
Result of ECG
integer
C1623258 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Result of ECG
Code List
Result of ECG
CL Item
normal (1)
CL Item
abnormal - not clinically significant (2)
CL Item
abnormal - clinically significant (3)
CL Item
no result (not available) (4)
Item Group
Exhaled nitric oxide
C3700245 (UMLS CUI-1)
Exhaled nitric oxide - Date
Item
Exhaled nitric oxide - Date
date
C3700245 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Planned relative time
text
C0439564 (UMLS CUI [1,1])
C3700245 (UMLS CUI [1,2])
Planned relative time
Code List
Planned relative time
CL Item
screening (screening)
CL Item
unscheduled (unscheduled)
Actual Time of First Reading
Item
Actual Time of First Reading
time
C3700245 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Reading 1
Item
Reading 1
float
C3700245 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Reading 2
Item
Reading 2
float
C3700245 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Reading 3
Item
Reading 3
float
C3700245 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Item Group
Pulmonary function tests / FEV 1
C0024119 (UMLS CUI-1)
C0429706 (UMLS CUI-2)
Date of FEV1
Item
Date of FEV1
date
C0011008 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Screening (Screening)
CL Item
Unscheduled (Unscheduled)
Pulmonary Function Time
Item
Pulmonary Function Time
time
C0040223 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
FEV1 Reading 1
Item
FEV1 Reading 1
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
FEV1 Reading 2
Item
FEV1 Reading 2
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
FEV1 Reading 3
Item
FEV1 Reading 3
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
FEV1 Highest Reading
Item
FEV1 Reading 1
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
FEV1 Predicted normal
Item
FEV1 predicted normal
float
C0748133 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
FEV1 percent predicted normal
Item
FEV1 percent predicted normal
float
C0730561 (UMLS CUI [1])
Item Group
Pulmonary function tests: Pre-AMP Challenge
C0024119 (UMLS CUI-1)
C1096479 (UMLS CUI-2)
C3812758 (UMLS CUI-3)
pre-AMP pulmonary function test date
Item
pre-AMP pulmonary function test date
date
C0011008 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C1096479 (UMLS CUI [1,3])
C3812758 (UMLS CUI [1,4])
Item
Planned relative Time
text
C0439564 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
Planned relative time
Code List
Planned relative Time
CL Item
pre-saline (pre-saline)
CL Item
unscheduled (unscheduled)
Time of FEV1
Item
Time of FEV1
time
C0040223 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
FEV1 Reading
Item
FEV1 Reading
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Item Group
Pulmonary function tests: AMP Challenge
C0024119 (UMLS CUI-1)
C1096479 (UMLS CUI-2)
AMP-Challenge Date
Item
AMP-Challenge Date
date
C0011008 (UMLS CUI [1,1])
C1096479 (UMLS CUI [1,2])
Item
Inhaled Substance
text
C0205535 (UMLS CUI [1,1])
C0001465 (UMLS CUI [1,2])
C0205535 (UMLS CUI [2,1])
C0036082 (UMLS CUI [2,2])
Inhaled Substance
Code List
Inhaled Substance
CL Item
Saline (Saline)
CL Item
Saline, unscheduled (Saline, unscheduled)
CL Item
AMP (AMP)
Item
Challenge Concentration (New subjects)
text
C1446561 (UMLS CUI [1,1])
C0001465 (UMLS CUI [1,2])
Challenge Concentration (New Subjects)
Code List
Challenge Concentration (New subjects)
CL Item
0.000 (0.000)
CL Item
0.039 (0.039)
CL Item
0.078 (0.078)
CL Item
0.156 (0.156)
CL Item
0.3125 (0.3125)
CL Item
0.625 (0.625)
CL Item
1.25 (1.25)
CL Item
2.5 (2.5)
CL Item
5 (5)
CL Item
10 (10)
CL Item
20 (20)
CL Item
40 (40)
CL Item
80 (80)
CL Item
160 (160)
CL Item
320 (320)
Challenge Concentration (Historical Concentration)
Item
Challenge Concentration (Historical concentration)
float
C1446561 (UMLS CUI [1,1])
C0001465 (UMLS CUI [1,2])
Start Time of Inhalation
Item
Start Time of Inhalation
time
C1301880 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
Stop Time of Inhalation
Item
Stop Time of Inhalation
time
C1522314 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
Item
Planned relative Time of FEV1
text
C0439564 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
C0748133 (UMLS CUI [1,3])
Planned relative Time of FEV1
Code List
Planned relative Time of FEV1
CL Item
60 secs post-inhalation (60 secs post-inhalation)
CL Item
180 secs post-inhalation (180 secs post-inhalation)
Pulmonary function time
Item
Pulmonary function time
time
C0040223 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
FEV1 Result
Item
FEV1 Result
float
C0429706 (UMLS CUI [1,1])
C1096479 (UMLS CUI [1,2])
Item Group
Pulmonary function tests: Post-AMP Challenge
C0231921 (UMLS CUI-1)
C1096479 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Date of post-challenge FEV1
Item
Date of post-challenge FEV1
date
C0011008 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Time of post-challenge FEV1
Item
Time of post-challenge FEV1
time
C0040223 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Result of post-challenge FEV1
Item
Result of post-challenge FEV1
float
C0429706 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Item Group
PC20 (AMP Challenge)
C1446561 (UMLS CUI-1)
C0001465 (UMLS CUI-2)
C0429706 (UMLS CUI-3)
C0547047 (UMLS CUI-4)
Date of challenge
Item
Date of challenge
date
C0011008 (UMLS CUI [1,1])
C1096479 (UMLS CUI [1,2])
PC20
Item
PC20
float
C1446561 (UMLS CUI [1,1])
C0001465 (UMLS CUI [1,2])
C0429706 (UMLS CUI [2,1])
C0547047 (UMLS CUI [2,2])
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