ID
32721
Descripción
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).
Palabras clave
Versiones (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 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
13 de novembro de 2018
DOI
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Licencia
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
Descripción
Alcohol Urine Test
Alias
- UMLS CUI-1
- C0202304
- UMLS CUI-2
- C0042036
Descripción
Date sample taken
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1302413
Descripción
If it's positive, EXCLUDE subject from the study
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C0042036
Descripción
Note the Initials
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C2986440
Descripción
Urine Cotinine Test
Alias
- UMLS CUI-1
- C1697737
Descripción
Date sample taken
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1302413
Descripción
If it's positive, EXCLUDE subject from the study
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1697737
Descripción
Note the Initials
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1697737
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C2986440
Descripción
Drugs of Abuse Screen
Alias
- UMLS CUI-1
- C0038577
Descripción
Date of sample
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1302413
Descripción
If positive, EXCLUDE subject from the study.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0376196
Descripción
If positive, EXCLUDE subject from the study.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0009170
Descripción
If positive, EXCLUDE subject from the study.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0004745
Descripción
If positive, EXCLUDE subject from the study.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0002667
Descripción
If positive, EXCLUDE subject from the study.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0005064
Descripción
If positive, EXCLUDE subject from the study.
Tipo de datos
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])