ID
29676
Description
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00318630
Keywords
Versions (1)
- 4/10/18 4/10/18 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
April 10, 2018
DOI
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License
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
Description
Sputum induction post-challenge
Alias
- UMLS CUI-1
- C2019319
Description
Time relative to Inhalation, e.g., Inhalation Period 1
Data type
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0205535
Description
Hr : Min 00:00 - 23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0001559
Description
Saline Concentration
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0036082
Description
FEV1
Data type
float
Measurement units
- L
Alias
- UMLS CUI [1]
- C0748133
Description
Bronchodilator administration
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0006280
- UMLS CUI [1,2]
- C1533734
Description
Dose administered
Data type
float
Measurement units
- µg
Alias
- UMLS CUI [1,1]
- C0006280
- UMLS CUI [1,2]
- C3174092
Description
Sputum post-challenge sample
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C0851347
Description
Date of assessment
Data type
date
Alias
- UMLS CUI [1]
- C2985720
Description
hr:min 00:00 - 23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0038056
Description
hr:min 00:00 - 23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1709694
- UMLS CUI [1,3]
- C0038056
Description
Sputum Sample Quality
Data type
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
Description
a
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0175730
Description
b
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0175730
- UMLS CUI [1,3]
- C0038056
Description
b - a = c
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0038056
Description
4 x c
Data type
float
Measurement units
- µL
Alias
- UMLS CUI [1,1]
- C0012789
- UMLS CUI [1,2]
- C2700258
Description
4 x c
Data type
float
Measurement units
- µL
Alias
- UMLS CUI [1,1]
- C2700258
- UMLS CUI [1,2]
- C0036082
- UMLS CUI [1,3]
- C0991865
Description
Refer to the Sputum Induction and Processing Reference Manual.
Data type
float
Measurement units
- mL
Alias
- UMLS CUI [1,1]
- C2700258
- UMLS CUI [1,2]
- C0439810
Description
Sputum hemacytometry post-challenge
Alias
- UMLS CUI-1
- C0038056
- UMLS CUI-2
- C0005771
- UMLS CUI-3
- C3856621
Description
Squares Counted
Data type
text
Alias
- UMLS CUI [1]
- C3856621
Description
Viable Leukocytes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C0443348
Description
Dead Leukocytes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C1306577
Description
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.
Data type
float
Measurement units
- cells/mL
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C0439810
Description
Total viable leukocyte = (Average number of viable leukocytes) x trypan blue dilution factor x 10^4
Data type
float
Measurement units
- cells/mL
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C0443348
- UMLS CUI [1,3]
- C0439810
Description
% viable leukocytes = (Total viable leukocytes) / (Total leukocytes) x 100.
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C0443348
- UMLS CUI [1,3]
- C0439165
Description
Sputum induction post-challenge summary
Alias
- UMLS CUI-1
- C0242482
- UMLS CUI-2
- C2019319
Description
Date of assessment
Data type
date
Alias
- UMLS CUI [1]
- C2985720
Description
Hr:Min 00:00 - 23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Description
Transcribe values from Resuspension segment.
Data type
float
Measurement units
- mL
Alias
- UMLS CUI [1,1]
- C2700258
- UMLS CUI [1,2]
- C1382107
Description
Transcribe values from Resuspension segment.
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0038056
Description
Transcribe values from Resuspension segment.
Data type
float
Measurement units
- cells/mL
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C0439810
Description
Number of Cytospin slides prepared
Data type
integer
Alias
- UMLS CUI [1,1]
- C3897072
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C4082130
Description
Number of Cytospin slides stained
Data type
integer
Alias
- UMLS CUI [1,1]
- C3897072
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0038128
Description
Number of supernatant aliquots saved
Data type
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C1510844
- UMLS CUI [1,3]
- C1550101
- UMLS CUI [1,4]
- C0003738
Description
Viability under 50 percent, over 40 percent squamous cells
Data type
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
Description
Sample Number: 203
Data type
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0038056
Description
Hr : Min (00:00 - 23:59) Time relative to dosing: post-challenge
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0038056
Description
Sputum slide results post-challenge
Alias
- UMLS CUI-1
- C3897072
- UMLS CUI-2
- C0038056
- UMLS CUI-3
- C1254595
Description
Date of assessment
Data type
date
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C3897072
Description
Number of Reader
Data type
integer
Alias
- UMLS CUI [1]
- C2986556
- UMLS CUI [2]
- C2986556
Description
Name of Reader
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Slide number
Data type
integer
Alias
- UMLS CUI [1,1]
- C3897072
- UMLS CUI [1,2]
- C0237753
Description
Absolute count of Eosinophils
Data type
integer
Alias
- UMLS CUI [1]
- C0200638
Description
Absolute count of Neutrophils
Data type
integer
Alias
- UMLS CUI [1]
- C0948762
Description
Absolute count of Macrophages
Data type
integer
Alias
- UMLS CUI [1]
- C1294065
Description
Absolute count of Lymphocytes
Data type
integer
Alias
- UMLS CUI [1]
- C3544087
Description
Absolute count of Bronchial epithelial cells
Data type
integer
Alias
- UMLS CUI [1,1]
- C1273342
- UMLS CUI [1,2]
- C0205039
Description
Absolute count of squamous cells
Data type
integer
Alias
- UMLS CUI [1]
- C2699511
Description
Total non-squamous cells
Data type
integer
Alias
- UMLS CUI [1,1]
- C0007584
- UMLS CUI [1,2]
- C1545484
- UMLS CUI [1,3]
- C0439810
Description
Total cells
Data type
integer
Alias
- UMLS CUI [1,1]
- C0007584
- UMLS CUI [1,2]
- C0439810
Description
Eosinophils: percent of total non squamous cells
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0200638
- UMLS CUI [1,2]
- C0439165
Description
Neutrophils: percent of total non squamous cells
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0948762
- UMLS CUI [1,2]
- C0439165
Description
Macrophages: percent of total non squamous cells
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C1294065
- UMLS CUI [1,2]
- C0439165
Description
Lymphocytes: percent of total non squamous cells
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C3544087
- UMLS CUI [1,2]
- C0439165
Description
Bronchial epithelial cells: percent of total non squamous cells
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C1273342
- UMLS CUI [1,2]
- C0205039
- UMLS CUI [1,3]
- C0439165
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Pharmacodynamics - Treatment period 2, Day 29
- StudyEvent: ODM
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