ID
41122
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)
- 26/6/20 26/6/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
26 de junio de 2020
DOI
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Licencia
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
Descripción
Demography
Alias
- UMLS CUI-1
- C0011298
Descripción
Date of Birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Sex
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0079399
Descripción
Ethnicity
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0015031
Descripción
Select all that apply
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0034510
Descripción
Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Descripción
Alcohol intake
Alias
- UMLS CUI-1
- C0001948
Descripción
Does the subject consume alcohol?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0001948
Descripción
Average number of units of alcohol consumed per week
Tipo de datos
integer
Unidades de medida
- units per week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Descripción
History of Tobacco Use
Alias
- UMLS CUI-1
- C0543414
Descripción
What is the subject's history of tobacco use?
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0841002
Descripción
If former smoker, when did the subject last smoke?
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0337671
- UMLS CUI [1,2]
- C0037369
- UMLS CUI [1,3]
- C1517741
Descripción
If former smoker, enter number of pack years
Tipo de datos
integer
Unidades de medida
- pack years
Alias
- UMLS CUI [1,1]
- C0337671
- UMLS CUI [1,2]
- C1277691
Descripción
Serology
Alias
- UMLS CUI-1
- C0036743
Descripción
Date sample taken
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1302413
Descripción
HIV antibody
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0019683
Descripción
Hepatitis B surface antigen
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0019168
Descripción
Hepatitis C antibody
Tipo de datos
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])