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

  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

Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Date of screening
Beschrijving

Date of screening

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1710477
Smoking History
Beschrijving

Smoking History

Alias
UMLS CUI-1
C1519384
What is the subject’s history of tobacco use?
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
If a former smoker, enter number of pack years
Beschrijving

Former smoker

Datatype

integer

Maateenheden
  • pack years
Alias
UMLS CUI [1]
C1277691
pack years
If former smoker, stopped in the last 12 months?
Beschrijving

Former smoker, date stopped

Datatype

text

Alias
UMLS CUI [1,1]
C0337671
UMLS CUI [1,2]
C0806020
Urine Cotinine Test
Beschrijving

Urine Cotinine Test

Alias
UMLS CUI-1
C1697737
Date sample taken
Beschrijving

Date sample taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Urine cotinine test
Beschrijving

If it's positive, EXCLUDE subject from the study

Datatype

text

Alias
UMLS CUI [1]
C1697737
Urine cotinine test, Tested by
Beschrijving

Note the Initials

Datatype

text

Alias
UMLS CUI [1,1]
C1697737
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C2986440

Similar models

Smoking history, urine cotinine test

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of screening
Item
Date of screening
date
C0011008 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
Item Group
Smoking History
C1519384 (UMLS CUI-1)
Item
What is the subject’s history of tobacco use?
text
C0543414 (UMLS CUI [1])
Code List
What is the subject’s history of tobacco use?
CL Item
Never smoked (V)
CL Item
Current smoker (C)
CL Item
Former smoker (F)
Former smoker
Item
If a former smoker, enter number of pack years
integer
C1277691 (UMLS CUI [1])
Item
If former smoker, stopped in the last 12 months?
text
C0337671 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Code List
If former smoker, stopped in the last 12 months?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Urine Cotinine Test
C1697737 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Urine cotinine test
text
C1697737 (UMLS CUI [1])
Code List
Urine cotinine test
CL Item
Positive (P)
CL Item
Negative (N)
Urine cotinine test, Tested by
Item
Urine cotinine test, Tested by
text
C1697737 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,3])

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