ID

41253

Beschreibung

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)

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  1. 25.07.20 25.07.20 -
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GlaxoSmithKline

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25. Juli 2020

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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

Englisch

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)

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Pulmonary Function Tests
Beschreibung

Pulmonary Function Tests

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

Pulmonary Function Tests - Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C2826247
Pulmonary Function Test
Beschreibung

Pulmonary Function Test

Datentyp

integer

Alias
UMLS CUI [1]
C0024119
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Planned Relative Time
Beschreibung

Planned Relative Time

Datentyp

integer

Alias
UMLS CUI [1]
C0439564
Pulmonary Function Time
Beschreibung

Pulmonary Function Time

Datentyp

time

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

Reading 1

Datentyp

float

Alias
UMLS CUI [1]
C0456984
Reading 2
Beschreibung

Reading 2

Datentyp

float

Alias
UMLS CUI [1]
C0456984
Reading 3
Beschreibung

Reading 3

Datentyp

float

Alias
UMLS CUI [1]
C0456984
Pulmonary Function Tests - Investigator Calculation
Beschreibung

Pulmonary Function Tests - Investigator Calculation

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C0008961
UMLS CUI-3
C1441506
Highest Reading A
Beschreibung

Highest Reading A

Datentyp

float

Alias
UMLS CUI [1,1]
C1522410
UMLS CUI [1,2]
C0456984
Predicted Normal B
Beschreibung

Predicted Normal B

Datentyp

float

Alias
UMLS CUI [1,1]
C0205307
UMLS CUI [1,2]
C0456984
% Predicted Normal A/Bx100
Beschreibung

% Predicted Normal A/Bx100

Datentyp

float

Alias
UMLS CUI [1,1]
C0205307
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0439165
Pulmonary Function Tests (Plethysmography Pre-Ipratropium Bromide)
Beschreibung

Pulmonary Function Tests (Plethysmography Pre-Ipratropium Bromide)

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C0032221
UMLS CUI-3
C0700580
UMLS CUI-4
C0439565
Pulmonary Function Tests (Plethysmography Pre-Ipratropium Bromide) - Date
Beschreibung

Pulmonary Function Tests (Plethysmography Pre-Ipratropium Bromide) - Date

Datentyp

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
Pulmonary Function Test (Plethysmography Pre-Ipratropium Bromide)
Beschreibung

Pulmonary Function Test (Plethysmography Pre-Ipratropium Bromide)

Datentyp

integer

Alias
UMLS CUI [1]
C0024119
UMLS CUI [2,1]
C0700580
UMLS CUI [2,2]
C0700580
UMLS CUI [2,3]
C0439565
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Planned Relative Time
Beschreibung

Planned Relative Time

Datentyp

integer

Alias
UMLS CUI [1]
C0439564
Pulmonary Function Time
Beschreibung

Pulmonary Function Time

Datentyp

time

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

Reading 1

Datentyp

float

Alias
UMLS CUI [1]
C0456984
Reading 2
Beschreibung

Reading 2

Datentyp

float

Alias
UMLS CUI [1]
C0456984
Reading 3
Beschreibung

Reading 3

Datentyp

float

Alias
UMLS CUI [1]
C0456984
Ipratropium Bromide Administration
Beschreibung

Ipratropium Bromide Administration

Alias
UMLS CUI-1
C0700580
UMLS CUI-2
C1533734
Date of Dose
Beschreibung

Date of Dose

Datentyp

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
Time of Dose
Beschreibung

Time of Dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide)
Beschreibung

Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide)

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C0032221
UMLS CUI-3
C0700580
UMLS CUI-4
C0439568
Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide) - Date
Beschreibung

Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide) - Date

Datentyp

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
Pulmonary Function Test (Plethysmography Post-Ipratropium Bromide)
Beschreibung

Pulmonary Function Test (Plethysmography Post-Ipratropium Bromide)

Datentyp

integer

Alias
UMLS CUI [1]
C0024119
UMLS CUI [2,1]
C0032221
UMLS CUI [2,2]
C0700580
UMLS CUI [2,3]
C0439568
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Planned Relative Time
Beschreibung

Planned Relative Time

Datentyp

integer

Alias
UMLS CUI [1]
C0439564
Pulmonary Funuction Time
Beschreibung

Pulmonary Funuction Time

Datentyp

time

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

Reading 1

Datentyp

float

Alias
UMLS CUI [1]
C0456984
Reading 2
Beschreibung

Reading 2

Datentyp

float

Alias
UMLS CUI [1]
C0456984
Reading 3
Beschreibung

Reading 3

Datentyp

float

Alias
UMLS CUI [1]
C0456984
Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide) - Investigator Calculation
Beschreibung

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
Mean Reading A
Beschreibung

Mean Reading A

Datentyp

float

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0444504
% Reversibility A2 - A1/ A1 x100
Beschreibung

% Reversibility A2 - A1/ A1 x100

Datentyp

float

Alias
UMLS CUI [1,1]
C0449261
UMLS CUI [1,2]
C0439165
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Ähnliche Modelle

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)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
C2826247 (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)
CL Item
FVC (2)
CL Item
FEV1/FVC (3)
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Screening (1)
CL Item
Unscheduled (2)
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 - Investigator Calculation
C0024119 (UMLS CUI-1)
C0008961 (UMLS CUI-2)
C1441506 (UMLS CUI-3)
Highest Reading A
Item
Highest Reading A
float
C1522410 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Predicted Normal B
Item
Predicted Normal B
float
C0205307 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
% Predicted Normal A/Bx100
Item
% Predicted Normal A/Bx100
float
C0205307 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Item Group
Pulmonary Function Tests (Plethysmography Pre-Ipratropium Bromide)
C0024119 (UMLS CUI-1)
C0032221 (UMLS CUI-2)
C0700580 (UMLS CUI-3)
C0439565 (UMLS CUI-4)
Pulmonary Function Tests (Plethysmography Pre-Ipratropium Bromide) - Date
Item
Pulmonary Function Tests (Plethysmography Pre-Ipratropium Bromide) - Date
date
C0024119 (UMLS CUI [1])
C0032221 (UMLS CUI [2,1])
C0700580 (UMLS CUI [2,2])
C0439565 (UMLS CUI [2,3])
C0011008 (UMLS CUI [3])
Item
Pulmonary Function Test (Plethysmography Pre-Ipratropium Bromide)
integer
C0024119 (UMLS CUI [1])
C0700580 (UMLS CUI [2,1])
C0700580 (UMLS CUI [2,2])
C0439565 (UMLS CUI [2,3])
Pulmonary Function Test (Plethysmography Pre-Ipratropium Bromide)
Code List
Pulmonary Function Test (Plethysmography Pre-Ipratropium Bromide)
CL Item
FEV1 (1)
CL Item
Raw (2)
CL Item
sGaw (3)
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Screening (1)
CL Item
Unscheduled (2)
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
Ipratropium Bromide Administration
C0700580 (UMLS CUI-1)
C1533734 (UMLS CUI-2)
Date of Dose
Item
Date of Dose
date
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Dose
Item
Time of Dose
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide)
C0024119 (UMLS CUI-1)
C0032221 (UMLS CUI-2)
C0700580 (UMLS CUI-3)
C0439568 (UMLS CUI-4)
Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide) - Date
Item
Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide) - Date
date
C0024119 (UMLS CUI [1])
C0032221 (UMLS CUI [2,1])
C0700580 (UMLS CUI [2,2])
C0439568 (UMLS CUI [2,3])
C0011008 (UMLS CUI [3])
Item
Pulmonary Function Test (Plethysmography Post-Ipratropium Bromide)
integer
C0024119 (UMLS CUI [1])
C0032221 (UMLS CUI [2,1])
C0700580 (UMLS CUI [2,2])
C0439568 (UMLS CUI [2,3])
Pulmonary Function Test (Plethysmography Post-Ipratropium Bromide)
Code List
Pulmonary Function Test (Plethysmography Post-Ipratropium Bromide)
CL Item
sGaw^1 (1)
CL Item
sGaw (2)
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-Ipratropium Bromide (1)
CL Item
Post-Ipratropium Bromide (2)
CL Item
Unscheduled (3)
Pulmonary Funuction Time
Item
Pulmonary Funuction 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 Post-Ipratropium Bromide) - Investigator Calculation
C0024119 (UMLS CUI-1)
C0032221 (UMLS CUI-2)
C0700580 (UMLS CUI-3)
C0439568 (UMLS CUI-4)
C0008961 (UMLS CUI-5)
C1441506 (UMLS CUI-6)
Mean Reading A
Item
Mean Reading A
float
C0456984 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
% Reversibility A2 - A1/ A1 x100
Item
% Reversibility A2 - A1/ A1 x100
float
C0449261 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
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