ID

41122

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)

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  1. 26-06-20 26-06-20 -
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GlaxoSmithKline

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26 juni 2020

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

Engels

Screening - Demography; Medical Conditions; Alcohol Intake; History of Tobacco Use; Serology

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Study Identifier
Beschrijving

Study Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Demography
Beschrijving

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Beschrijving

Date of Birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschrijving

Sex

Datatype

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschrijving

Ethnicity

Datatype

integer

Alias
UMLS CUI [1]
C0015031
Race
Beschrijving

Select all that apply

Datatype

integer

Alias
UMLS CUI [1]
C0034510
Medical Conditions
Beschrijving

Medical Conditions

Alias
UMLS CUI-1
C0012634
Diagnosis
Beschrijving

Only in the absence of a diagnosis, record the signs and symptoms on serparate lines

Datatype

text

Alias
UMLS CUI [1]
C0011900
Medical Condition Status
Beschrijving

Medical Condition Status

Datatype

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
Alcohol intake
Beschrijving

Alcohol intake

Alias
UMLS CUI-1
C0001948
Does the subject consume alcohol?
Beschrijving

Does the subject consume alcohol?

Datatype

boolean

Alias
UMLS CUI [1]
C0001948
Average number of units of alcohol consumed per week
Beschrijving

Average number of units of alcohol consumed per week

Datatype

integer

Maateenheden
  • units per week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
units per week
History of Tobacco Use
Beschrijving

History of Tobacco Use

Alias
UMLS CUI-1
C0543414
What is the subject's history of tobacco use?
Beschrijving

What is the subject's history of tobacco use?

Datatype

integer

Alias
UMLS CUI [1]
C0841002
If former smoker, when did the subject last smoke?
Beschrijving

If former smoker, when did the subject last smoke?

Datatype

date

Alias
UMLS CUI [1,1]
C0337671
UMLS CUI [1,2]
C0037369
UMLS CUI [1,3]
C1517741
If former smoker, enter number of pack years
Beschrijving

If former smoker, enter number of pack years

Datatype

integer

Maateenheden
  • pack years
Alias
UMLS CUI [1,1]
C0337671
UMLS CUI [1,2]
C1277691
pack years
Serology
Beschrijving

Serology

Alias
UMLS CUI-1
C0036743
Date sample taken
Beschrijving

Date sample taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
HIV antibody
Beschrijving

HIV antibody

Datatype

integer

Alias
UMLS CUI [1]
C0019683
Hepatitis B surface antigen
Beschrijving

Hepatitis B surface antigen

Datatype

integer

Alias
UMLS CUI [1]
C0019168
Hepatitis C antibody
Beschrijving

Hepatitis C antibody

Datatype

integer

Alias
UMLS CUI [1]
C0201487
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Similar models

Screening - Demography; Medical Conditions; Alcohol Intake; History of Tobacco Use; Serology

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study Identifier
Item
Study Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Item Group
Medical Conditions
C0012634 (UMLS CUI-1)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Medical Condition Status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Medical Condition Status
Code List
Medical Condition Status
CL Item
Current (1)
CL Item
Past (2)
Item Group
Alcohol intake
C0001948 (UMLS CUI-1)
Does the subject consume alcohol?
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
Average number of units of alcohol consumed per week
Item
Average number of units of alcohol consumed per week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
History of Tobacco Use
C0543414 (UMLS CUI-1)
Item
What is the subject's history of tobacco use?
integer
C0841002 (UMLS CUI [1])
What is the subject's history of tobacco use?
Code List
What is the subject's history of tobacco use?
CL Item
never smoked (1)
CL Item
Current smoker (2)
CL Item
Former smoker (3)
If former smoker, when did the subject last smoke?
Item
If former smoker, when did the subject last smoke?
date
C0337671 (UMLS CUI [1,1])
C0037369 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
If former smoker, enter number of pack years
Item
If former smoker, enter number of pack years
integer
C0337671 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
Item Group
Serology
C0036743 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
HIV antibody
integer
C0019683 (UMLS CUI [1])
HIV antibody
Code List
HIV antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis B surface antigen
integer
C0019168 (UMLS CUI [1])
Hepatitis B surface antigen
Code List
Hepatitis B surface antigen
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis C antibody
integer
C0201487 (UMLS CUI [1])
Hepatitis C antibody
Code List
Hepatitis C antibody
CL Item
Positive (1)
CL Item
Negative (2)
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