ID
32832
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 smoking history of subject and urine cotinine test. It has to be filled in at screening.
Trefwoorden
Versies (1)
- 16-11-18 16-11-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
16 november 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
Smoking history, urine cotinine test
- StudyEvent: ODM
Beschrijving
Smoking History
Alias
- UMLS CUI-1
- C1519384
Beschrijving
Tick one box only. NOTE: Subject should be a lifetime non-smoker or an ex-smoker of >1 year duration with a <5 year pack history to be eligible to participate in this study.
Datatype
text
Alias
- UMLS CUI [1]
- C0543414
Beschrijving
Former smoker
Datatype
integer
Maateenheden
- pack years
Alias
- UMLS CUI [1]
- C1277691
Beschrijving
Former smoker, date stopped
Datatype
text
Alias
- UMLS CUI [1,1]
- C0337671
- UMLS CUI [1,2]
- C0806020
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
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Smoking history, urine cotinine test
- StudyEvent: ODM
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C2986440 (UMLS CUI [1,3])