ID

32832

Description

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.

Keywords

Versions (1)
  1. 16.11.18 16.11.18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

16. November 2018

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License

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

English

Smoking history, urine cotinine test

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of screening
Description

Date of screening

Data type

date

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

Smoking History

Alias
UMLS CUI-1
C1519384
What is the subject’s history of tobacco use?
Description

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.

Data type

text

Alias
UMLS CUI [1]
C0543414
If a former smoker, enter number of pack years
Description

Former smoker

Data type

integer

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

Former smoker, date stopped

Data type

text

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

Urine Cotinine Test

Alias
UMLS CUI-1
C1697737
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Urine cotinine test
Description

If it's positive, EXCLUDE subject from the study

Data type

text

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

Note the Initials

Data type

text

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

Smoking history, urine cotinine test

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
History of tobacco use
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])
Former smoker, date stopped
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])
Urine cotinine test
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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