ID
29678
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 1, Day 29. Sputum Induction.
Link
https://clinicaltrials.gov/ct2/show/NCT00318630
Stichworte
Versionen (2)
- 10.04.18 10.04.18 - Sarah Riepenhausen
- 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
Pharmacodynamics - Treatment period 1, Day 29
- StudyEvent: ODM
Beschreibung
Sputum induction post-challenge
Alias
- UMLS CUI-1
- C2019319
Beschreibung
Time relative to Inhalation, e.g., Inhalation Period 1
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0205535
Beschreibung
Hr : Min 00:00 - 23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0001559
Beschreibung
Saline Concentration
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0036082
Beschreibung
FEV1
Datentyp
float
Maßeinheiten
- L
Alias
- UMLS CUI [1]
- C0748133
Beschreibung
Bronchodilator administration
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0006280
- UMLS CUI [1,2]
- C1533734
Beschreibung
Dose administered
Datentyp
float
Maßeinheiten
- µg
Alias
- UMLS CUI [1,1]
- C0006280
- UMLS CUI [1,2]
- C3174092
Beschreibung
Sputum post-challenge sample
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C0851347
Beschreibung
Date of assessment
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
hr:min 00:00 - 23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0038056
Beschreibung
hr:min 00:00 - 23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1709694
- UMLS CUI [1,3]
- C0038056
Beschreibung
Sputum Sample Quality
Datentyp
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
Beschreibung
a
Datentyp
float
Maßeinheiten
- mg
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0175730
Beschreibung
b
Datentyp
float
Maßeinheiten
- mg
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0175730
- UMLS CUI [1,3]
- C0038056
Beschreibung
b - a = c
Datentyp
float
Maßeinheiten
- mg
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0038056
Beschreibung
4 x c
Datentyp
float
Maßeinheiten
- µL
Alias
- UMLS CUI [1,1]
- C0012789
- UMLS CUI [1,2]
- C2700258
Beschreibung
4 x c
Datentyp
float
Maßeinheiten
- µL
Alias
- UMLS CUI [1,1]
- C2700258
- UMLS CUI [1,2]
- C0036082
- UMLS CUI [1,3]
- C0991865
Beschreibung
Refer to the Sputum Induction and Processing Reference Manual.
Datentyp
float
Maßeinheiten
- mL
Alias
- UMLS CUI [1,1]
- C2700258
- UMLS CUI [1,2]
- C0439810
Beschreibung
Sputum hemacytometry post-challenge
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C0005771
- UMLS CUI-3
- C3856621
Beschreibung
Squares Counted
Datentyp
text
Alias
- UMLS CUI [1]
- C3856621
Beschreibung
Viable Leukocytes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C0443348
Beschreibung
Dead Leukocytes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C1306577
Beschreibung
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.
Datentyp
float
Maßeinheiten
- cells/mL
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C0439810
Beschreibung
Total viable leukocyte = (Average number of viable leukocytes) x trypan blue dilution factor x 10^4
Datentyp
float
Maßeinheiten
- cells/mL
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C0443348
- UMLS CUI [1,3]
- C0439810
Beschreibung
% viable leukocytes = (Total viable leukocytes) / (Total leukocytes) x 100.
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C0443348
- UMLS CUI [1,3]
- C0439165
Beschreibung
Sputum induction post-challenge summary
Alias
- UMLS CUI-1
- C0242482
- UMLS CUI-2
- C2019319
Beschreibung
Date of assessment
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Hr:Min 00:00 - 23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschreibung
Transcribe values from Resuspension segment.
Datentyp
float
Maßeinheiten
- mL
Alias
- UMLS CUI [1,1]
- C2700258
- UMLS CUI [1,2]
- C1382107
Beschreibung
Transcribe values from Resuspension segment.
Datentyp
float
Maßeinheiten
- mg
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0038056
Beschreibung
Transcribe values from Resuspension segment.
Datentyp
float
Maßeinheiten
- cells/mL
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C0439810
Beschreibung
Number of Cytospin slides prepared
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3897072
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C4082130
Beschreibung
Number of Cytospin slides stained
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3897072
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0038128
Beschreibung
Number of supernatant aliquots saved
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C1510844
- UMLS CUI [1,3]
- C1550101
- UMLS CUI [1,4]
- C0003738
Beschreibung
Viability under 50 percent, over 40 percent squamous cells
Datentyp
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
Beschreibung
Sample Number: 103
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0038056
Beschreibung
Hr : Min (00:00 - 23:59) Time relative to dosing: post-challenge
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0038056
Beschreibung
Sputum slide results post-challenge
Alias
- UMLS CUI-1
- C3897072
- UMLS CUI-2
- C0038056
- UMLS CUI-3
- C1254595
Beschreibung
Date of assessment
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C3897072
Beschreibung
Number of Reader
Datentyp
integer
Alias
- UMLS CUI [1]
- C2986556
- UMLS CUI [2]
- C2986556
Beschreibung
Name of Reader
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Slide number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3897072
- UMLS CUI [1,2]
- C0237753
Beschreibung
Absolute count of Eosinophils
Datentyp
integer
Alias
- UMLS CUI [1]
- C0200638
Beschreibung
Absolute count of Neutrophils
Datentyp
integer
Alias
- UMLS CUI [1]
- C0948762
Beschreibung
Absolute count of Macrophages
Datentyp
integer
Alias
- UMLS CUI [1]
- C1294065
Beschreibung
Absolute count of Lymphocytes
Datentyp
integer
Alias
- UMLS CUI [1]
- C3544087
Beschreibung
Absolute count of Bronchial epithelial cells
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1273342
- UMLS CUI [1,2]
- C0205039
Beschreibung
Absolute count of squamous cells
Datentyp
integer
Alias
- UMLS CUI [1]
- C2699511
Beschreibung
Total non-squamous cells
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0007584
- UMLS CUI [1,2]
- C1545484
- UMLS CUI [1,3]
- C0439810
Beschreibung
Total cells
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0007584
- UMLS CUI [1,2]
- C0439810
Beschreibung
Eosinophils: percent of total non squamous cells
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1,1]
- C0200638
- UMLS CUI [1,2]
- C0439165
Beschreibung
Neutrophils: percent of total non squamous cells
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1,1]
- C0948762
- UMLS CUI [1,2]
- C0439165
Beschreibung
Macrophages: percent of total non squamous cells
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1,1]
- C1294065
- UMLS CUI [1,2]
- C0439165
Beschreibung
Lymphocytes: percent of total non squamous cells
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1,1]
- C3544087
- UMLS CUI [1,2]
- C0439165
Beschreibung
Bronchial epithelial cells: percent of total non squamous cells
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1,1]
- C1273342
- UMLS CUI [1,2]
- C0205039
- UMLS CUI [1,3]
- C0439165
Ähnliche Modelle
Pharmacodynamics - Treatment period 1, 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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