ID

41254

Descripción

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)

Palabras clave

Versiones (1)
  1. 25/7/20 25/7/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

25 de julio de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

Inglés

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

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Pulmonary Function Tests
Descripción

Pulmonary Function Tests

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

Pulmonary Function Tests - Date

Tipo de datos

date

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

Pulmonary Function Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0024119
Units
Descripción

Units

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Planned Relative Time
Descripción

Planned Relative Time

Tipo de datos

integer

Alias
UMLS CUI [1]
C0439564
Pulmonary Function Time
Descripción

Pulmonary Function Time

Tipo de datos

time

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

Reading 1

Tipo de datos

float

Alias
UMLS CUI [1]
C0456984
Reading 2
Descripción

Reading 2

Tipo de datos

float

Alias
UMLS CUI [1]
C0456984
Reading 3
Descripción

Reading 3

Tipo de datos

float

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

Pulmonary Function Tests (Plethysmography)

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

Pulmonary Function Tests (Plethysmography)

Tipo de datos

integer

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

Units

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Planned Relative Time
Descripción

Planned Relative Time

Tipo de datos

integer

Alias
UMLS CUI [1]
C0439564
Pulmonary Function Time
Descripción

Pulmonary Function Time

Tipo de datos

time

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

Reading 1

Tipo de datos

float

Alias
UMLS CUI [1]
C0456984
Reading 2
Descripción

Reading 2

Tipo de datos

float

Alias
UMLS CUI [1]
C0456984
Reading 3
Descripción

Reading 3

Tipo de datos

float

Alias
UMLS CUI [1]
C0456984
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Pulmonary Function Tests; Plethysmography (Treatment Period 1-5)

1 formularios
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Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
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C1320722 (UMLS CUI-1)
Subject Identifier
Item
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Item Group
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Code List
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CL Item
FEV1 (1)
Item
Units
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Units
Code List
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CL Item
L (1)
Item
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C0439564 (UMLS CUI [1])
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Code List
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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)
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Unscheduled (9)
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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
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C0456984 (UMLS CUI [1])
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C0456984 (UMLS CUI [1])
Item Group
Pulmonary Function Tests (Plethysmography)
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Pulmonary Function Tests (Plethysmography)
integer
C0024119 (UMLS CUI [1])
C0032221 (UMLS CUI [2])
Pulmonary Function Tests (Plethysmography)
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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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