ID
29676
Beskrivning
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 29. Sputum Induction.
Länk
https://clinicaltrials.gov/ct2/show/NCT00318630
Nyckelord
Versioner (1)
- 2018-04-10 2018-04-10 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
10 april 2018
DOI
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Licens
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
Pharmacodynamics - Treatment period 2, Day 29
- StudyEvent: ODM
Beskrivning
Sputum induction post-challenge
Alias
- UMLS CUI-1
- C2019319
Beskrivning
Time relative to Inhalation, e.g., Inhalation Period 1
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0205535
Beskrivning
Hr : Min 00:00 - 23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0001559
Beskrivning
Saline Concentration
Datatyp
float
Måttenheter
- %
Alias
- UMLS CUI [1]
- C0036082
Beskrivning
FEV1
Datatyp
float
Måttenheter
- L
Alias
- UMLS CUI [1]
- C0748133
Beskrivning
Bronchodilator administration
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0006280
- UMLS CUI [1,2]
- C1533734
Beskrivning
Dose administered
Datatyp
float
Måttenheter
- µg
Alias
- UMLS CUI [1,1]
- C0006280
- UMLS CUI [1,2]
- C3174092
Beskrivning
Sputum post-challenge sample
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C0851347
Beskrivning
Date of assessment
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
hr:min 00:00 - 23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0038056
Beskrivning
hr:min 00:00 - 23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1709694
- UMLS CUI [1,3]
- C0038056
Beskrivning
Sputum Sample Quality
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0038056
- UMLS CUI [1,2]
- C0332306
- UMLS CUI [2]
- C1880121
- UMLS CUI [3]
- C0241235
- UMLS CUI [4,1]
- C0005767
- UMLS CUI [4,2]
- C2349974
Beskrivning
a
Datatyp
float
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0175730
Beskrivning
b
Datatyp
float
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0175730
- UMLS CUI [1,3]
- C0038056
Beskrivning
b - a = c
Datatyp
float
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0038056
Beskrivning
4 x c
Datatyp
float
Måttenheter
- µL
Alias
- UMLS CUI [1,1]
- C0012789
- UMLS CUI [1,2]
- C2700258
Beskrivning
4 x c
Datatyp
float
Måttenheter
- µL
Alias
- UMLS CUI [1,1]
- C2700258
- UMLS CUI [1,2]
- C0036082
- UMLS CUI [1,3]
- C0991865
Beskrivning
Refer to the Sputum Induction and Processing Reference Manual.
Datatyp
float
Måttenheter
- mL
Alias
- UMLS CUI [1,1]
- C2700258
- UMLS CUI [1,2]
- C0439810
Beskrivning
Sputum hemacytometry post-challenge
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C0005771
- UMLS CUI-3
- C3856621
Beskrivning
Squares Counted
Datatyp
text
Alias
- UMLS CUI [1]
- C3856621
Beskrivning
Viable Leukocytes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C0443348
Beskrivning
Dead Leukocytes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C1306577
Beskrivning
Refer to the Sputum Induction and Processing Reference Manual. Total leukocyte count (cells/mL) = (Average number of viable + dead leukocytes) x trypan blue dilution factor x 10^4.
Datatyp
float
Måttenheter
- cells/mL
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C0439810
Beskrivning
Total viable leukocyte = (Average number of viable leukocytes) x trypan blue dilution factor x 10^4
Datatyp
float
Måttenheter
- cells/mL
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C0443348
- UMLS CUI [1,3]
- C0439810
Beskrivning
% viable leukocytes = (Total viable leukocytes) / (Total leukocytes) x 100.
Datatyp
float
Måttenheter
- %
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C0443348
- UMLS CUI [1,3]
- C0439165
Beskrivning
Sputum induction post-challenge summary
Alias
- UMLS CUI-1
- C0242482
- UMLS CUI-2
- C2019319
Beskrivning
Date of assessment
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
Hr:Min 00:00 - 23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beskrivning
Transcribe values from Resuspension segment.
Datatyp
float
Måttenheter
- mL
Alias
- UMLS CUI [1,1]
- C2700258
- UMLS CUI [1,2]
- C1382107
Beskrivning
Transcribe values from Resuspension segment.
Datatyp
float
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0038056
Beskrivning
Transcribe values from Resuspension segment.
Datatyp
float
Måttenheter
- cells/mL
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C0439810
Beskrivning
Number of Cytospin slides prepared
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3897072
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C4082130
Beskrivning
Number of Cytospin slides stained
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3897072
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0038128
Beskrivning
Number of supernatant aliquots saved
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C1510844
- UMLS CUI [1,3]
- C1550101
- UMLS CUI [1,4]
- C0003738
Beskrivning
Viability under 50 percent, over 40 percent squamous cells
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0007634
- UMLS CUI [1,3]
- C0443348
- UMLS CUI [1,4]
- C0439165
- UMLS CUI [2,1]
- C0439165
- UMLS CUI [2,2]
- C2699511
Beskrivning
Sample Number: 203
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0038056
Beskrivning
Hr : Min (00:00 - 23:59) Time relative to dosing: post-challenge
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0038056
Beskrivning
Sputum slide results post-challenge
Alias
- UMLS CUI-1
- C3897072
- UMLS CUI-2
- C0038056
- UMLS CUI-3
- C1254595
Beskrivning
Date of assessment
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C3897072
Beskrivning
Number of Reader
Datatyp
integer
Alias
- UMLS CUI [1]
- C2986556
- UMLS CUI [2]
- C2986556
Beskrivning
Name of Reader
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Slide number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3897072
- UMLS CUI [1,2]
- C0237753
Beskrivning
Absolute count of Eosinophils
Datatyp
integer
Alias
- UMLS CUI [1]
- C0200638
Beskrivning
Absolute count of Neutrophils
Datatyp
integer
Alias
- UMLS CUI [1]
- C0948762
Beskrivning
Absolute count of Macrophages
Datatyp
integer
Alias
- UMLS CUI [1]
- C1294065
Beskrivning
Absolute count of Lymphocytes
Datatyp
integer
Alias
- UMLS CUI [1]
- C3544087
Beskrivning
Absolute count of Bronchial epithelial cells
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1273342
- UMLS CUI [1,2]
- C0205039
Beskrivning
Absolute count of squamous cells
Datatyp
integer
Alias
- UMLS CUI [1]
- C2699511
Beskrivning
Total non-squamous cells
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0007584
- UMLS CUI [1,2]
- C1545484
- UMLS CUI [1,3]
- C0439810
Beskrivning
Total cells
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0007584
- UMLS CUI [1,2]
- C0439810
Beskrivning
Eosinophils: percent of total non squamous cells
Datatyp
float
Måttenheter
- %
Alias
- UMLS CUI [1,1]
- C0200638
- UMLS CUI [1,2]
- C0439165
Beskrivning
Neutrophils: percent of total non squamous cells
Datatyp
float
Måttenheter
- %
Alias
- UMLS CUI [1,1]
- C0948762
- UMLS CUI [1,2]
- C0439165
Beskrivning
Macrophages: percent of total non squamous cells
Datatyp
float
Måttenheter
- %
Alias
- UMLS CUI [1,1]
- C1294065
- UMLS CUI [1,2]
- C0439165
Beskrivning
Lymphocytes: percent of total non squamous cells
Datatyp
float
Måttenheter
- %
Alias
- UMLS CUI [1,1]
- C3544087
- UMLS CUI [1,2]
- C0439165
Beskrivning
Bronchial epithelial cells: percent of total non squamous cells
Datatyp
float
Måttenheter
- %
Alias
- UMLS CUI [1,1]
- C1273342
- UMLS CUI [1,2]
- C0205039
- UMLS CUI [1,3]
- C0439165
Similar models
Pharmacodynamics - Treatment period 2, Day 29
- StudyEvent: ODM
C0429706 (UMLS CUI-2)
C0038056 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0205535 (UMLS CUI [1,2])
C0001559 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
C0851347 (UMLS CUI-2)
C0200345 (UMLS CUI [1,2])
C0038056 (UMLS CUI [1,3])
C1709694 (UMLS CUI [1,2])
C0038056 (UMLS CUI [1,3])
C0332306 (UMLS CUI [1,2])
C1880121 (UMLS CUI [2])
C0241235 (UMLS CUI [3])
C0005767 (UMLS CUI [4,1])
C2349974 (UMLS CUI [4,2])
C0175730 (UMLS CUI [1,2])
C0175730 (UMLS CUI [1,2])
C0038056 (UMLS CUI [1,3])
C0038056 (UMLS CUI [1,2])
C2700258 (UMLS CUI [1,2])
C0036082 (UMLS CUI [1,2])
C0991865 (UMLS CUI [1,3])
C0439810 (UMLS CUI [1,2])
C0005771 (UMLS CUI-2)
C3856621 (UMLS CUI-3)
C0443348 (UMLS CUI [1,2])
C1306577 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,2])
C0443348 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C0443348 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C2019319 (UMLS CUI-2)
C0200345 (UMLS CUI [1,2])
C1382107 (UMLS CUI [1,2])
C0038056 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
C4082130 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,2])
C0038128 (UMLS CUI [1,3])
C1510844 (UMLS CUI [1,2])
C1550101 (UMLS CUI [1,3])
C0003738 (UMLS CUI [1,4])
C0007634 (UMLS CUI [1,2])
C0443348 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
C0439165 (UMLS CUI [2,1])
C2699511 (UMLS CUI [2,2])
C0038056 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,2])
C0038056 (UMLS CUI [1,3])
C0038056 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
C3897072 (UMLS CUI [1,2])
C0205039 (UMLS CUI [1,2])
C1545484 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C0439810 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,2])
C0205039 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
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