ID
33000
Beskrivning
Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the form for pharmacokinetic blood sampling,investigational products and their administration. It has to be filled in for session 2-6.
Nyckelord
Versioner (3)
- 2018-11-15 2018-11-15 -
- 2018-11-22 2018-11-22 -
- 2018-11-23 2018-11-23 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
23 november 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877
Pharmacokinetic Blood Sampling, lnvestigational Product
- StudyEvent: ODM
Beskrivning
Pharmacokinetic Blood Sampling
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
- UMLS CUI-3
- C0870078
Beskrivning
Row no.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0237753
Beskrivning
day month year.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
Beskrivning
time relative to dosing
Datatyp
integer
Alias
- UMLS CUI [1]
- C0439564
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1]
- C0040223
Beskrivning
Sample number
Datatyp
integer
Alias
- UMLS CUI [1]
- C1299222
Beskrivning
Tick if taken. Please take for sample number BLD001, BLD003-BLD013. It does not have to be taken for sample number BLD002.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0117996
- UMLS CUI [1,2]
- C0200345
Beskrivning
Tick if taken. Please take for sample number BLD001-BLD006 and BLD008. It does not have to be taken for: BLD007, BLD009-BLD013
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0073992
- UMLS CUI [1,2]
- C0200345
Beskrivning
lnvestigational Product
Alias
- UMLS CUI-1
- C0304229
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Beskrivning
Number of inhalations
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0354922
- UMLS CUI [1,2]
- C0237753
Beskrivning
Significant changes refer to investigational product not administered as per the requirements of the protocol.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3845681
- UMLS CUI [1,2]
- C0304229
Beskrivning
Specify investigational product change
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C3845681
- UMLS CUI [1,3]
- C0304229
Beskrivning
lnvestigational Product Administration Worksheet
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C1533734
Beskrivning
Tick appropriate box(es). Each participant of the study will use each of the 5 application methods in the course of the study. Which method will be used during which treatment period is determined by randomization.
Datatyp
text
Alias
- UMLS CUI [1]
- C0304229
Beskrivning
initials
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0027361
- UMLS CUI [1,3]
- C1533734
Beskrivning
initials
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1621583
- UMLS CUI [1,3]
- C1283174
Similar models
Pharmacokinetic Blood Sampling, lnvestigational Product
- StudyEvent: ODM
C0005767 (UMLS CUI-2)
C0870078 (UMLS CUI-3)
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C3845681 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1533734 (UMLS CUI-2)
C0027361 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,3])
C1621583 (UMLS CUI [1,2])
C1283174 (UMLS CUI [1,3])