ID

41254

Beschrijving

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)

Trefwoorden

Versies (1)
  1. 25-07-20 25-07-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

25 juli 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

Engels

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

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Pulmonary Function Tests
Beschrijving

Pulmonary Function Tests

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

Pulmonary Function Tests - Date

Datatype

date

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

Pulmonary Function Test

Datatype

integer

Alias
UMLS CUI [1]
C0024119
Units
Beschrijving

Units

Datatype

integer

Alias
UMLS CUI [1]
C1519795
Planned Relative Time
Beschrijving

Planned Relative Time

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Pulmonary Function Time
Beschrijving

Pulmonary Function Time

Datatype

time

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

Reading 1

Datatype

float

Alias
UMLS CUI [1]
C0456984
Reading 2
Beschrijving

Reading 2

Datatype

float

Alias
UMLS CUI [1]
C0456984
Reading 3
Beschrijving

Reading 3

Datatype

float

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

Pulmonary Function Tests (Plethysmography)

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

Pulmonary Function Tests (Plethysmography)

Datatype

integer

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

Units

Datatype

integer

Alias
UMLS CUI [1]
C1519795
Planned Relative Time
Beschrijving

Planned Relative Time

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Pulmonary Function Time
Beschrijving

Pulmonary Function Time

Datatype

time

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

Reading 1

Datatype

float

Alias
UMLS CUI [1]
C0456984
Reading 2
Beschrijving

Reading 2

Datatype

float

Alias
UMLS CUI [1]
C0456984
Reading 3
Beschrijving

Reading 3

Datatype

float

Alias
UMLS CUI [1]
C0456984
Terug naar het begin van de pagina

Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial