ID

41254

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)
  1. 7/25/20 7/25/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 25, 2020

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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)

English

Pulmonary Function Tests; Plethysmography (Treatment Period 1-5)

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Pulmonary Function Tests
Description

Pulmonary Function Tests

Alias
UMLS CUI-1
C0024119
Pulmonary Function Tests - Date
Description

Pulmonary Function Tests - Date

Data type

date

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0011008
Pulmonary Function Test
Description

Pulmonary Function Test

Data type

integer

Alias
UMLS CUI [1]
C0024119
Units
Description

Units

Data type

integer

Alias
UMLS CUI [1]
C1519795
Planned Relative Time
Description

Planned Relative Time

Data type

integer

Alias
UMLS CUI [1]
C0439564
Pulmonary Function Time
Description

Pulmonary Function Time

Data type

time

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0040223
Reading 1
Description

Reading 1

Data type

float

Alias
UMLS CUI [1]
C0456984
Reading 2
Description

Reading 2

Data type

float

Alias
UMLS CUI [1]
C0456984
Reading 3
Description

Reading 3

Data type

float

Alias
UMLS CUI [1]
C0456984
Pulmonary Function Tests (Plethysmography)
Description

Pulmonary Function Tests (Plethysmography)

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C0032221
Pulmonary Function Tests (Plethysmography)
Description

Pulmonary Function Tests (Plethysmography)

Data type

integer

Alias
UMLS CUI [1]
C0024119
UMLS CUI [2]
C0032221
Units
Description

Units

Data type

integer

Alias
UMLS CUI [1]
C1519795
Planned Relative Time
Description

Planned Relative Time

Data type

integer

Alias
UMLS CUI [1]
C0439564
Pulmonary Function Time
Description

Pulmonary Function Time

Data type

time

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0040223
Reading 1
Description

Reading 1

Data type

float

Alias
UMLS CUI [1]
C0456984
Reading 2
Description

Reading 2

Data type

float

Alias
UMLS CUI [1]
C0456984
Reading 3
Description

Reading 3

Data type

float

Alias
UMLS CUI [1]
C0456984
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Similar models

Pulmonary Function Tests; Plethysmography (Treatment Period 1-5)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Pulmonary Function Tests
C0024119 (UMLS CUI-1)
Pulmonary Function Tests - Date
Item
Pulmonary Function Tests - Date
date
C0024119 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pulmonary Function Test
integer
C0024119 (UMLS CUI [1])
Pulmonary Function Test
Code List
Pulmonary Function Test
CL Item
FEV1 (1)
Item
Units
integer
C1519795 (UMLS CUI [1])
Units
Code List
Units
CL Item
L (1)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
1 hr (2)
CL Item
2 hrs (3)
CL Item
6 hrs (4)
CL Item
9 hrs (5)
CL Item
12 hrs (6)
CL Item
22 hrs (7)
CL Item
24 hrs (8)
CL Item
Unscheduled (9)
Pulmonary Function Time
Item
Pulmonary Function Time
time
C0024119 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Reading 1
Item
Reading 1
float
C0456984 (UMLS CUI [1])
Reading 2
Item
Reading 2
float
C0456984 (UMLS CUI [1])
Reading 3
Item
Reading 3
float
C0456984 (UMLS CUI [1])
Item Group
Pulmonary Function Tests (Plethysmography)
C0024119 (UMLS CUI-1)
C0032221 (UMLS CUI-2)
Item
Pulmonary Function Tests (Plethysmography)
integer
C0024119 (UMLS CUI [1])
C0032221 (UMLS CUI [2])
Pulmonary Function Tests (Plethysmography)
Code List
Pulmonary Function Tests (Plethysmography)
CL Item
Raw (1)
CL Item
sGaw (2)
Item
Units
integer
C1519795 (UMLS CUI [1])
Units
Code List
Units
CL Item
kPa/L/Sec (1)
CL Item
L/Sec/kPa/L (2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
2 hrs (2)
CL Item
6 hrs (3)
CL Item
9 hrs (4)
CL Item
12 hrs (5)
CL Item
22 hrs (6)
CL Item
24 hrs (7)
CL Item
36 hrs (8)
CL Item
48 hrs (9)
CL Item
Unscheduled (10)
Pulmonary Function Time
Item
Pulmonary Function Time
time
C0024119 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Reading 1
Item
Reading 1
float
C0456984 (UMLS CUI [1])
Reading 2
Item
Reading 2
float
C0456984 (UMLS CUI [1])
Reading 3
Item
Reading 3
float
C0456984 (UMLS CUI [1])
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