ID
32721
Beschrijving
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 alcohol urin test, urin cotinine test and drug screen form. The Drug of Abuse has to be filled in for period 1, 2, 3, 4 and 5. The alcohol urin test and urin cotinine test have to be filled in at screening (session 1).
Trefwoorden
Versies (4)
- 13/11/2018 13/11/2018 -
- 16/11/2018 16/11/2018 -
- 22/11/2018 22/11/2018 -
- 22/11/2018 22/11/2018 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
13 de novembro de 2018
DOI
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Licentie
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
Alcohol urin test, Drug screen.
- StudyEvent: ODM
Beschrijving
Alcohol Urine Test
Alias
- UMLS CUI-1
- C0202304
- UMLS CUI-2
- C0042036
Beschrijving
Date sample taken
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
If it's positive, EXCLUDE subject from the study
Datatype
text
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C0042036
Beschrijving
Note the Initials
Datatype
text
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C2986440
Beschrijving
Urine Cotinine Test
Alias
- UMLS CUI-1
- C1697737
Beschrijving
Date sample taken
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
If it's positive, EXCLUDE subject from the study
Datatype
text
Alias
- UMLS CUI [1]
- C1697737
Beschrijving
Note the Initials
Datatype
text
Alias
- UMLS CUI [1,1]
- C1697737
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C2986440
Beschrijving
Drugs of Abuse Screen
Alias
- UMLS CUI-1
- C0038577
Beschrijving
Date of sample
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
If positive, EXCLUDE subject from the study.
Datatype
text
Alias
- UMLS CUI [1]
- C0376196
Beschrijving
If positive, EXCLUDE subject from the study.
Datatype
text
Alias
- UMLS CUI [1]
- C0009170
Beschrijving
If positive, EXCLUDE subject from the study.
Datatype
text
Alias
- UMLS CUI [1]
- C0004745
Beschrijving
If positive, EXCLUDE subject from the study.
Datatype
text
Alias
- UMLS CUI [1]
- C0002667
Beschrijving
If positive, EXCLUDE subject from the study.
Datatype
text
Alias
- UMLS CUI [1]
- C0005064
Beschrijving
If positive, EXCLUDE subject from the study.
Datatype
text
Alias
- UMLS CUI [1]
- C0936079
Similar models
Alcohol urin test, Drug screen.
- StudyEvent: ODM
C1948053 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,3])
C0008961 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,3])