ID

29674

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 Lung function testing: Exhaled nitric oxide, pulmonary function tests, Methacholine Challenge. Time: Treatment Period 2, Day 29.

Link

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

Stichworte

Versionen (1)
  1. 10/04/18 10/04/18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10 aprile 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

Lung function testing - Treatment Period 2, Day 29

1 Formulare  
Exhaled nitric oxide
Beschreibung

Exhaled nitric oxide

Alias
UMLS CUI-1
C3700245
Date of Exhaled nitric oxide test
Beschreibung

e.g., 08 JAN 04

Datentyp

date

Alias
UMLS CUI [1,1]
C3700245
UMLS CUI [1,2]
C2826247
Planned relative time
Beschreibung

Time relative to dosing

Datentyp

text

Alias
UMLS CUI [1]
C0439564
Actual time of first reading
Beschreibung

hr:min 00:00 - 23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C3700245
Reading 1 of Nictric Oxide
Beschreibung

e.g., 50.7

Datentyp

float

Maßeinheiten
  • ppb
Alias
UMLS CUI [1,1]
C0028128
UMLS CUI [1,2]
C0456984
ppb
Reading 2 of Nictric Oxide
Beschreibung

e.g., 51.0

Datentyp

float

Maßeinheiten
  • ppb
Alias
UMLS CUI [1,1]
C0028128
UMLS CUI [1,2]
C0456984
ppb
Reading 3 of Nictric Oxide
Beschreibung

e.g., 51.3

Datentyp

float

Maßeinheiten
  • ppb
Alias
UMLS CUI [1,1]
C0028128
UMLS CUI [1,2]
C0456984
ppb
Pulmonary function tests / FEV 1
Beschreibung

Pulmonary function tests / FEV 1

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

Date of FEV1

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0429706
Planned relative Time of FEV1
Beschreibung

Time relative to Dosing.

Datentyp

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0429706
Time of FEV1
Beschreibung

Hr : Min 00:00-23:59

Datentyp

time

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

Reading 1 of FEV1

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
Reading 2 of FEV1
Beschreibung

Reading 2 of FEV1

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
Reading 3 of FEV1
Beschreibung

Reading 3 of FEV1

Datentyp

float

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

Pulmonary function tests: Pre-Methacholine Challenge

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C0430567
UMLS CUI-3
C3812758
pre-Methacholine pulmonary function test date
Beschreibung

pre-Methacholine pulmonary function test date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0024119
UMLS CUI [1,3]
C0430567
UMLS CUI [1,4]
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: Methacholine Challenge
Beschreibung

Pulmonary function tests: Methacholine Challenge

Alias
UMLS CUI-1
C0748133
UMLS CUI-2
C0430567
Methacholine Challenge Date
Beschreibung

Methacholine Challenge Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0748133
UMLS CUI [1,3]
C0430567
Inhaled Substance
Beschreibung

Inhaled Substance

Datentyp

text

Alias
UMLS CUI [1,1]
C0205535
UMLS CUI [1,2]
C0600370
UMLS CUI [2,1]
C0205535
UMLS CUI [2,2]
C0036082
Challenge Concentration (New Subjects)
Beschreibung

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

Datentyp

text

Maßeinheiten
  • mg/mL
Alias
UMLS CUI [1,1]
C1446561
UMLS CUI [1,2]
C0600370
Challenge Concentration (Historical concentration)
Beschreibung

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 Methacholine (provocholine) until a ≥20percent fall in FEV1 from the baseline saline value is achieved. Use 0.000 for saline inhaltation.

Datentyp

float

Maßeinheiten
  • mg/mL
Alias
UMLS CUI [1,1]
C1446561
UMLS CUI [1,2]
C0600370
mg/mL
Start Time of Inhalation
Beschreibung

Fill in only for saline inhalation and new subjects.

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

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

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]
C0430567
L
Pulmonary function tests: Post-Methacholine Challenge
Beschreibung

Pulmonary function tests: Post-Methacholine Challenge

Alias
UMLS CUI-1
C0231921
UMLS CUI-2
C0430567
UMLS CUI-3
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 of post-challenge FEV1
Beschreibung

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

Datentyp

time

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

Record use of rescue Salbutamol on the Concomitant Medications page.

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

Lung function testing - Treatment Period 2, Day 29

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Exhaled nitric oxide
C3700245 (UMLS CUI-1)
Date of Exhaled nitric oxide test
Item
Date of Exhaled nitric oxide test
date
C3700245 (UMLS CUI [1,1])
C2826247 (UMLS CUI [1,2])
Item
Planned relative time
text
C0439564 (UMLS CUI [1])
Planned relative time
Code List
Planned relative time
CL Item
unscheduled (unscheduled)
(Comment:en)
CL Item
within 1 hr post-challenge (within 1 hr post-challenge)
(Comment:en)
CL Item
pre-challenge (pre-challenge)
(Comment:en)
Actual time of first reading
Item
Actual time of first reading
time
C0040223 (UMLS CUI [1,1])
C3700245 (UMLS CUI [1,2])
Reading 1 of Nictric Oxide
Item
Reading 1 of Nictric Oxide
float
C0028128 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Reading 2 of Nictric Oxide
Item
Reading 2 of Nictric Oxide
float
C0028128 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Reading 3 of Nictric Oxide
Item
Reading 3 of Nictric Oxide
float
C0028128 (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 of FEV1
text
C0439564 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Planned relative Time of FEV1
Code List
Planned relative Time of FEV1
CL Item
unscheduled (unscheduled)
(Comment:en)
CL Item
pre-challenge (pre-challenge)
(Comment:en)
CL Item
post-challenge (discharge) (post-challenge (discharge))
(Comment:en)
Time of FEV1
Item
Time of FEV1
time
C0040223 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Reading 1 of FEV1
Item
Reading 1 of FEV1
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Reading 2 of FEV1
Item
Reading 2 of FEV1
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Reading 3 of FEV1
Item
Reading 3 of FEV1
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Item Group
Pulmonary function tests: Pre-Methacholine Challenge
C0024119 (UMLS CUI-1)
C0430567 (UMLS CUI-2)
C3812758 (UMLS CUI-3)
pre-Methacholine pulmonary function test date
Item
pre-Methacholine pulmonary function test date
date
C0011008 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C0430567 (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: Methacholine Challenge
C0748133 (UMLS CUI-1)
C0430567 (UMLS CUI-2)
Methacholine Challenge Date
Item
Methacholine Challenge Date
date
C0011008 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
C0430567 (UMLS CUI [1,3])
Item
Inhaled Substance
text
C0205535 (UMLS CUI [1,1])
C0600370 (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
Metacholine (Metacholine)
Item
Challenge Concentration (New Subjects)
text
C1446561 (UMLS CUI [1,1])
C0600370 (UMLS CUI [1,2])
Challenge Concentration (New Subjects)
Code List
Challenge Concentration (New Subjects)
CL Item
0.000 (0.000)
CL Item
0.03125 (0.03125)
CL Item
0.06250 (0.06250)
CL Item
0.125 (0.125)
CL Item
0.25 (0.25)
CL Item
0.5 (0.5)
CL Item
1 (1)
CL Item
2 (2)
CL Item
4 (4)
CL Item
8 (8)
CL Item
16 (16)
CL Item
32 (32)
Challenge Concentration (Historical concentration)
Item
Challenge Concentration (Historical concentration)
float
C1446561 (UMLS CUI [1,1])
C0600370 (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])
C0430567 (UMLS CUI [1,2])
Item Group
Pulmonary function tests: Post-Methacholine Challenge
C0231921 (UMLS CUI-1)
C0430567 (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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