ID

29670

Beschreibung

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 28. Blood and Asthma allergen Challenge.

Link

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

Stichworte

Versionen (1)
  1. 10.04.18 10.04.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. April 2018

DOI

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Lizenz

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

Englisch

Pharmacodynamics - Treatment period 2, Day 28

1 Formulare  
Blood
Beschreibung

Blood

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0851347
UMLS CUI-3
C0201734
Sample Number
Beschreibung

Sample Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1299222
UMLS CUI [1,2]
C0201734
UMLS CUI [2,1]
C1299222
UMLS CUI [2,2]
C0851347
Date sample Taken
Beschreibung

If sample is missed or lost, write "NA".

Datentyp

date

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

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

Datentyp

time

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0040223
Pulmonary function tests: pre-asthma-allergen challenge
Beschreibung

Pulmonary function tests: pre-asthma-allergen challenge

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C0006265
UMLS CUI-3
C0002092
UMLS CUI-4
C0439565
pre-asthma-allergen pulmonary function test date
Beschreibung

pre-asthma-allergen pulmonary function test date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0024119
UMLS CUI [1,3]
C0006265
UMLS CUI [1,4]
C0002092
UMLS CUI [1,5]
C3812758
Planned relative Time
Beschreibung

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

Datentyp

text

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

Time of FEV1

Datentyp

time

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

FEV1 Reading

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
Pulmonary function tests: asthma-allergen Challenge
Beschreibung

Pulmonary function tests: asthma-allergen Challenge

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C0006265
UMLS CUI-3
C0002092
asthma-allergen challenge date
Beschreibung

asthma-allergen challenge date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0006265
UMLS CUI [1,3]
C0002092
Inhaled Substance
Beschreibung

Inhaled Substance

Datentyp

text

Alias
UMLS CUI [1,1]
C0205535
UMLS CUI [1,2]
C0002092
UMLS CUI [2,1]
C0205535
UMLS CUI [2,2]
C0036082
Challenge Concentration
Beschreibung

Baseline FEV1 measurements were first taken using saline. During the challenge at screening the final concentration of allergen was determined when a fall in FEV1 of >15percent from the baseline value was achieved. 0.000 is the concentration value for saline.

Datentyp

text

Maßeinheiten
  • SQU/mL
Alias
UMLS CUI [1,1]
C1446561
UMLS CUI [1,2]
C0002092
Start Time of Inhalation
Beschreibung

Fill in only for saline inhalation.

Datentyp

time

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

Stop Time of Inhalation

Datentyp

time

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

Time relative to stop time of inhalation. Timepoints 2, 3 and 4 minutes postinhalation are only to be used for post-saline-inhalation (all three have to be done); 5 and 10 minutes post-inhalation are only for post-allergen-inhalation measurements (both have to be done for each allergen concentration).

Datentyp

text

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

Pulmonary function time

Datentyp

time

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

FEV1 Result

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0429706
UMLS CUI [1,2]
C0006265
UMLS CUI [1,3]
C0002092
L
Pulmonary function tests: Post-asthma-allergen Challenge
Beschreibung

Pulmonary function tests: Post-asthma-allergen Challenge

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C0006265
UMLS CUI-3
C0002092
UMLS CUI-4
C0439568
Date of post-challenge FEV1
Beschreibung

Date of post-challenge FEV1

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0429706
UMLS CUI [1,3]
C0439568
Time relative to end of challenge
Beschreibung

Salbutamol should be administered after the 10hrs post-challenge measurement. Record use of rescue Salbutamol on the Concomitant Medications page.

Datentyp

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0429706
UMLS CUI [1,3]
C0439568
Time of post-challenge FEV1
Beschreibung

Time of post-challenge FEV1

Datentyp

time

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

Reading 1 of post-challenge FEV1

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0429706
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0439568
L
Reading 2 of post-challenge FEV1
Beschreibung

Not to be done for timepoints 15, 20, 30 and 45 mins.

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0429706
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0439568
L
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Ähnliche Modelle

Pharmacodynamics - Treatment period 2, Day 28

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Blood
C0005834 (UMLS CUI-1)
C0851347 (UMLS CUI-2)
C0201734 (UMLS CUI-3)
Item
Sample Number
integer
C1299222 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2,1])
C0851347 (UMLS CUI [2,2])
Sample Number
Code List
Sample Number
CL Item
Pharmacodynamics (203)
CL Item
Pharmacokinetics (201)
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-asthma-allergen challenge
C0024119 (UMLS CUI-1)
C0006265 (UMLS CUI-2)
C0002092 (UMLS CUI-3)
C0439565 (UMLS CUI-4)
pre-asthma-allergen pulmonary function test date
Item
pre-asthma-allergen pulmonary function test date
date
C0011008 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C0006265 (UMLS CUI [1,3])
C0002092 (UMLS CUI [1,4])
C3812758 (UMLS CUI [1,5])
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: asthma-allergen Challenge
C0024119 (UMLS CUI-1)
C0006265 (UMLS CUI-2)
C0002092 (UMLS CUI-3)
asthma-allergen challenge date
Item
asthma-allergen challenge date
date
C0011008 (UMLS CUI [1,1])
C0006265 (UMLS CUI [1,2])
C0002092 (UMLS CUI [1,3])
Item
Inhaled Substance
text
C0205535 (UMLS CUI [1,1])
C0002092 (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
Allergen (Allergen)
Item
Challenge Concentration
text
C1446561 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
Challenge Concentration
Code List
Challenge Concentration
CL Item
0.000 (0.000)
CL Item
250 (250)
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
2 mins post-inhalation (saline) (2 mins post-inhalation (saline))
CL Item
3 mins post-inhalation (saline) (3 mins post-inhalation (saline))
CL Item
4 mins post inhalation (saline) (4 mins post inhalation (saline))
CL Item
5 mins post-inhalation (allergen) (5 mins post-inhalation (allergen))
CL Item
10 mins post-inhalation (allergen) (10 mins post-inhalation (allergen))
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])
C0006265 (UMLS CUI [1,2])
C0002092 (UMLS CUI [1,3])
Item Group
Pulmonary function tests: Post-asthma-allergen Challenge
C0024119 (UMLS CUI-1)
C0006265 (UMLS CUI-2)
C0002092 (UMLS CUI-3)
C0439568 (UMLS CUI-4)
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])
Item
Time relative to end of challenge
text
C0439564 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Time of post-challenge FEV1
Code List
Time relative to end of challenge
CL Item
15 mins (15 mins)
CL Item
20 mins (20 mins)
CL Item
30 mins (30 mins)
CL Item
45 mins (45 mins)
CL Item
60 mins (60 mins)
CL Item
1.5 hrs (1.5 hrs)
CL Item
2 hrs (2 hrs)
CL Item
2.5 hrs (2.5 hrs)
CL Item
3 hrs (3 hrs)
CL Item
3.5 hrs (3.5 hrs)
CL Item
4 hrs (4 hrs)
CL Item
4.5 hrs (4.5 hrs)
CL Item
5 hrs (5 hrs)
CL Item
5.5 hrs (5.5 hrs)
CL Item
6 hrs (6 hrs)
CL Item
6.5 hrs (6.5 hrs)
CL Item
7 hrs (7 hrs)
CL Item
7.5 hrs (7.5 hrs)
CL Item
8 hrs (8 hrs)
CL Item
8.5 hrs (8.5 hrs)
CL Item
9 hrs (9 hrs)
CL Item
9.5 hrs (9.5 hrs)
CL Item
10 hrs (10 hrs)
CL Item
12 hrs (12 hrs)
CL Item
24 hrs (24 hrs)
CL Item
unscheduled (unscheduled)
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])
Reading 1 of post-challenge FEV1
Item
Reading 1 of post-challenge FEV1
float
C0429706 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Reading 2 of post-challenge FEV1
Item
Reading 2 of post-challenge FEV1
float
C0429706 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
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