ID

29657

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 Pharmacodynamics. Time: Treatment period 2, Day 14. Part 1: Blood and AMP Challenge

Link

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

Trefwoorden

Versies (1)
  1. 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

Pharmacodynamics - Treatment period 2, Day 14, Part 1

1 Formulieren  
Blood
Beschrijving

Blood

Alias
UMLS CUI-1
C0851347
UMLS CUI-2
C0005834
Date sample Taken
Beschrijving

If sample is missed or lost, write "NA". Sample Number: 202

Datatype

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C1277698
Actual Time sample taken
Beschrijving

Hr : Min (00:00 - 23:59) Time relative to dosing: Pre-dose

Datatype

time

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0040223
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
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
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
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Similar models

Pharmacodynamics - Treatment period 2, Day 14, Part 1

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Blood
C0851347 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
Date sample Taken
Item
Date sample Taken
date
C1302413 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
Time sample taken
Item
Actual Time sample taken
time
C1277698 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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
text
C1446561 (UMLS CUI [1,1])
C0001465 (UMLS CUI [1,2])
Challenge Concentration (New Subjects)
Code List
Challenge Concentration
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)
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])
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