ID
41253
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)
- 2020-07-25 2020-07-25 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
25 juli 2020
DOI
För en begäran logga in.
Licens
Creative Commons BY 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)
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)
Beskrivning
Pulmonary Function Tests
Alias
- UMLS CUI-1
- C0024119
Beskrivning
Pulmonary Function Tests - Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C2826247
Beskrivning
Pulmonary Function Test
Datatyp
integer
Alias
- UMLS CUI [1]
- C0024119
Beskrivning
Units
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Planned Relative Time
Datatyp
integer
Alias
- UMLS CUI [1]
- C0439564
Beskrivning
Pulmonary Function Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0040223
Beskrivning
Reading 1
Datatyp
float
Alias
- UMLS CUI [1]
- C0456984
Beskrivning
Reading 2
Datatyp
float
Alias
- UMLS CUI [1]
- C0456984
Beskrivning
Reading 3
Datatyp
float
Alias
- UMLS CUI [1]
- C0456984
Beskrivning
Pulmonary Function Tests - Investigator Calculation
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0008961
- UMLS CUI-3
- C1441506
Beskrivning
Highest Reading A
Datatyp
float
Alias
- UMLS CUI [1,1]
- C1522410
- UMLS CUI [1,2]
- C0456984
Beskrivning
Predicted Normal B
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0205307
- UMLS CUI [1,2]
- C0456984
Beskrivning
% Predicted Normal A/Bx100
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0205307
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0439165
Beskrivning
Pulmonary Function Tests (Plethysmography Pre-Ipratropium Bromide)
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0032221
- UMLS CUI-3
- C0700580
- UMLS CUI-4
- C0439565
Beskrivning
Pulmonary Function Tests (Plethysmography Pre-Ipratropium Bromide) - Date
Datatyp
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
Beskrivning
Pulmonary Function Test (Plethysmography Pre-Ipratropium Bromide)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2,1]
- C0700580
- UMLS CUI [2,2]
- C0700580
- UMLS CUI [2,3]
- C0439565
Beskrivning
Units
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Planned Relative Time
Datatyp
integer
Alias
- UMLS CUI [1]
- C0439564
Beskrivning
Pulmonary Function Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0040223
Beskrivning
Reading 1
Datatyp
float
Alias
- UMLS CUI [1]
- C0456984
Beskrivning
Reading 2
Datatyp
float
Alias
- UMLS CUI [1]
- C0456984
Beskrivning
Reading 3
Datatyp
float
Alias
- UMLS CUI [1]
- C0456984
Beskrivning
Ipratropium Bromide Administration
Alias
- UMLS CUI-1
- C0700580
- UMLS CUI-2
- C1533734
Beskrivning
Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide)
Alias
- UMLS CUI-1
- C0024119
- UMLS CUI-2
- C0032221
- UMLS CUI-3
- C0700580
- UMLS CUI-4
- C0439568
Beskrivning
Pulmonary Function Tests (Plethysmography Post-Ipratropium Bromide) - Date
Datatyp
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
Beskrivning
Pulmonary Function Test (Plethysmography Post-Ipratropium Bromide)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0024119
- UMLS CUI [2,1]
- C0032221
- UMLS CUI [2,2]
- C0700580
- UMLS CUI [2,3]
- C0439568
Beskrivning
Units
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Planned Relative Time
Datatyp
integer
Alias
- UMLS CUI [1]
- C0439564
Beskrivning
Pulmonary Funuction Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0040223
Beskrivning
Reading 1
Datatyp
float
Alias
- UMLS CUI [1]
- C0456984
Beskrivning
Reading 2
Datatyp
float
Alias
- UMLS CUI [1]
- C0456984
Beskrivning
Reading 3
Datatyp
float
Alias
- UMLS CUI [1]
- C0456984
Beskrivning
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
Similar models
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)
C2826247 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0008961 (UMLS CUI-2)
C1441506 (UMLS CUI-3)
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0032221 (UMLS CUI-2)
C0700580 (UMLS CUI-3)
C0439565 (UMLS CUI-4)
C0032221 (UMLS CUI [2,1])
C0700580 (UMLS CUI [2,2])
C0439565 (UMLS CUI [2,3])
C0011008 (UMLS CUI [3])
C0700580 (UMLS CUI [2,1])
C0700580 (UMLS CUI [2,2])
C0439565 (UMLS CUI [2,3])
C0040223 (UMLS CUI [1,2])
C1533734 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0032221 (UMLS CUI-2)
C0700580 (UMLS CUI-3)
C0439568 (UMLS CUI-4)
C0032221 (UMLS CUI [2,1])
C0700580 (UMLS CUI [2,2])
C0439568 (UMLS CUI [2,3])
C0011008 (UMLS CUI [3])
C0032221 (UMLS CUI [2,1])
C0700580 (UMLS CUI [2,2])
C0439568 (UMLS CUI [2,3])
C0040223 (UMLS CUI [1,2])
C0032221 (UMLS CUI-2)
C0700580 (UMLS CUI-3)
C0439568 (UMLS CUI-4)
C0008961 (UMLS CUI-5)
C1441506 (UMLS CUI-6)
C0444504 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,2])