ID
41253
Description
Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Versions (1)
- 7/25/20 7/25/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
July 25, 2020
DOI
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License
Creative Commons BY 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)
Pulmonary Function Tests; Pulmonary Function Tests - Investigator Calculation; Plethysmography Pre-Ipratropium Bromide; Ipratropium Bromide Administration; Plethysmography Post-Ipratropium Bromide; Plethysmography Post-Ipratropium Bromide - Investigator Calculation (Screening)
Description
Pulmonary Function Tests
Alias
- UMLS CUI-1
- C0024119
Description
Pulmonary Function Tests - Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C2826247
Description
Pulmonary Function Test
Data type
integer
Alias
- UMLS CUI [1]
- C0024119
Description
Units
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Planned Relative Time
Data type
integer
Alias
- UMLS CUI [1]
- C0439564
Description
Pulmonary Function Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0040223
Description
Reading 1
Data type
float
Alias
- UMLS CUI [1]
- C0456984
Description
Reading 2
Data type
float
Alias
- UMLS CUI [1]
- C0456984
Description
Reading 3
Data type
float
Alias
- UMLS CUI [1]
- C0456984
Description
Pulmonary Function Tests - Investigator Calculation
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0008961
- UMLS CUI-3
- C1441506
Description
Highest Reading A
Data type
float
Alias
- UMLS CUI [1,1]
- C1522410
- UMLS CUI [1,2]
- C0456984
Description
Predicted Normal B
Data type
float
Alias
- UMLS CUI [1,1]
- C0205307
- UMLS CUI [1,2]
- C0456984
Description
% Predicted Normal A/Bx100
Data type
float
Alias
- UMLS CUI [1,1]
- C0205307
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0439165
Description
Pulmonary Function Tests (Plethysmography Pre-Ipratropium Bromide)
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0032221
- UMLS CUI-3
- C0700580
- UMLS CUI-4
- C0439565
Description
Pulmonary Function Tests (Plethysmography Pre-Ipratropium Bromide) - Date
Data type
date
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2,1]
- C0032221
- UMLS CUI [2,2]
- C0700580
- UMLS CUI [2,3]
- C0439565
- UMLS CUI [3]
- C0011008
Description
Pulmonary Function Test (Plethysmography Pre-Ipratropium Bromide)
Data type
integer
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2,1]
- C0700580
- UMLS CUI [2,2]
- C0700580
- UMLS CUI [2,3]
- C0439565
Description
Units
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Planned Relative Time
Data type
integer
Alias
- UMLS CUI [1]
- C0439564
Description
Pulmonary Function Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0040223
Description
Reading 1
Data type
float
Alias
- UMLS CUI [1]
- C0456984
Description
Reading 2
Data type
float
Alias
- UMLS CUI [1]
- C0456984
Description
Reading 3
Data type
float
Alias
- UMLS CUI [1]
- C0456984
Description
Ipratropium Bromide Administration
Alias
- UMLS CUI-1
- C0700580
- UMLS CUI-2
- C1533734
Description
Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide)
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0032221
- UMLS CUI-3
- C0700580
- UMLS CUI-4
- C0439568
Description
Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide) - Date
Data type
date
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2,1]
- C0032221
- UMLS CUI [2,2]
- C0700580
- UMLS CUI [2,3]
- C0439568
- UMLS CUI [3]
- C0011008
Description
Pulmonary Function Test (Plethysmography Post-Ipratropium Bromide)
Data type
integer
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2,1]
- C0032221
- UMLS CUI [2,2]
- C0700580
- UMLS CUI [2,3]
- C0439568
Description
Units
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Planned Relative Time
Data type
integer
Alias
- UMLS CUI [1]
- C0439564
Description
Pulmonary Funuction Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0040223
Description
Reading 1
Data type
float
Alias
- UMLS CUI [1]
- C0456984
Description
Reading 2
Data type
float
Alias
- UMLS CUI [1]
- C0456984
Description
Reading 3
Data type
float
Alias
- UMLS CUI [1]
- C0456984
Description
Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide) - Investigator Calculation
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0032221
- UMLS CUI-3
- C0700580
- UMLS CUI-4
- C0439568
- UMLS CUI-5
- C0008961
- UMLS CUI-6
- C1441506
Similar models
Pulmonary Function Tests; Pulmonary Function Tests - Investigator Calculation; Plethysmography Pre-Ipratropium Bromide; Ipratropium Bromide Administration; Plethysmography Post-Ipratropium Bromide; Plethysmography Post-Ipratropium Bromide - Investigator Calculation (Screening)
C2826247 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0008961 (UMLS CUI-2)
C1441506 (UMLS CUI-3)
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0032221 (UMLS CUI-2)
C0700580 (UMLS CUI-3)
C0439565 (UMLS CUI-4)
C0032221 (UMLS CUI [2,1])
C0700580 (UMLS CUI [2,2])
C0439565 (UMLS CUI [2,3])
C0011008 (UMLS CUI [3])
C0700580 (UMLS CUI [2,1])
C0700580 (UMLS CUI [2,2])
C0439565 (UMLS CUI [2,3])
C0040223 (UMLS CUI [1,2])
C1533734 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0032221 (UMLS CUI-2)
C0700580 (UMLS CUI-3)
C0439568 (UMLS CUI-4)
C0032221 (UMLS CUI [2,1])
C0700580 (UMLS CUI [2,2])
C0439568 (UMLS CUI [2,3])
C0011008 (UMLS CUI [3])
C0032221 (UMLS CUI [2,1])
C0700580 (UMLS CUI [2,2])
C0439568 (UMLS CUI [2,3])
C0040223 (UMLS CUI [1,2])
C0032221 (UMLS CUI-2)
C0700580 (UMLS CUI-3)
C0439568 (UMLS CUI-4)
C0008961 (UMLS CUI-5)
C1441506 (UMLS CUI-6)
C0444504 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,2])