ID
41122
Beskrivning
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)
Nyckelord
Versioner (1)
- 2020-06-26 2020-06-26 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
26 juni 2020
DOI
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Licens
Creative Commons BY-NC 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)
Screening - Demography; Medical Conditions; Alcohol Intake; History of Tobacco Use; Serology
Beskrivning
Demography
Alias
- UMLS CUI-1
- C0011298
Beskrivning
Date of Birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Sex
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Ethnicity
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beskrivning
Select all that apply
Datatyp
integer
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Beskrivning
Alcohol intake
Alias
- UMLS CUI-1
- C0001948
Beskrivning
Does the subject consume alcohol?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001948
Beskrivning
Average number of units of alcohol consumed per week
Datatyp
integer
Måttenheter
- units per week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Beskrivning
History of Tobacco Use
Alias
- UMLS CUI-1
- C0543414
Beskrivning
What is the subject's history of tobacco use?
Datatyp
integer
Alias
- UMLS CUI [1]
- C0841002
Beskrivning
If former smoker, when did the subject last smoke?
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0337671
- UMLS CUI [1,2]
- C0037369
- UMLS CUI [1,3]
- C1517741
Beskrivning
If former smoker, enter number of pack years
Datatyp
integer
Måttenheter
- pack years
Alias
- UMLS CUI [1,1]
- C0337671
- UMLS CUI [1,2]
- C1277691
Beskrivning
Serology
Alias
- UMLS CUI-1
- C0036743
Beskrivning
Date sample taken
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
HIV antibody
Datatyp
integer
Alias
- UMLS CUI [1]
- C0019683
Beskrivning
Hepatitis B surface antigen
Datatyp
integer
Alias
- UMLS CUI [1]
- C0019168
Beskrivning
Hepatitis C antibody
Datatyp
integer
Alias
- UMLS CUI [1]
- C0201487
Similar models
Screening - Demography; Medical Conditions; Alcohol Intake; History of Tobacco Use; Serology
C0449438 (UMLS CUI [1,2])
C0560579 (UMLS CUI [1,2])
C0037369 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1277691 (UMLS CUI [1,2])