ID

32963

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 urine test and drug screen form. Their have to be filled in for period 1, 2, 3, 4 and 5 and for screening.

Trefwoorden

  1. 13-11-18 13-11-18 -
  2. 16-11-18 16-11-18 -
  3. 22-11-18 22-11-18 -
  4. 22-11-18 22-11-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

22 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

Alcohol urine test, Drug screen.

Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Screening/ Treatment Period Number
Beschrijving

Screening/ Treatment Period Number

Datatype

integer

Alias
UMLS CUI [1]
C0220908
UMLS CUI [2,1]
C0237753
UMLS CUI [2,2]
C1948053
Alcohol Urine Test
Beschrijving

Alcohol Urine Test

Alias
UMLS CUI-1
C0202304
UMLS CUI-2
C0042036
Date sample taken
Beschrijving

Date sample taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Alcohol urine test
Beschrijving

If it's positive, EXCLUDE subject from the study

Datatype

text

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C0042036
Alcohol urine test, Tested by
Beschrijving

Note the Initials

Datatype

text

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C2986440
Drugs of Abuse Screen
Beschrijving

Drugs of Abuse Screen

Alias
UMLS CUI-1
C0038577
Date of sample taken
Beschrijving

Date of sample

Datatype

date

Alias
UMLS CUI [1]
C1302413
Opiates
Beschrijving

If positive, EXCLUDE subject from the study.

Datatype

text

Alias
UMLS CUI [1]
C0376196
Cocaine
Beschrijving

If positive, EXCLUDE subject from the study.

Datatype

text

Alias
UMLS CUI [1]
C0009170
Barbiturates
Beschrijving

If positive, EXCLUDE subject from the study.

Datatype

text

Alias
UMLS CUI [1]
C0004745
Amphetamines
Beschrijving

If positive, EXCLUDE subject from the study.

Datatype

text

Alias
UMLS CUI [1]
C0002667
Benzodiazepines
Beschrijving

If positive, EXCLUDE subject from the study.

Datatype

text

Alias
UMLS CUI [1]
C0005064
Cannabis
Beschrijving

If positive, EXCLUDE subject from the study.

Datatype

text

Alias
UMLS CUI [1]
C0936079

Similar models

Alcohol urine test, Drug screen.

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])
Item
Screening/ Treatment Period Number
integer
C0220908 (UMLS CUI [1])
C0237753 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
Code List
Screening/ Treatment Period Number
CL Item
Screening (1)
CL Item
Treatment Period 1  (2)
CL Item
Treatment Period 2 (3)
CL Item
Treatment Period 3 (4)
CL Item
Treatment Period 4 (5)
CL Item
Treatment Period 5 (6)
Item Group
Alcohol Urine Test
C0202304 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Alcohol urine test
text
C0202304 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
Code List
Alcohol urine test
CL Item
Positive (P)
CL Item
Negative (N)
Alcohol urine test, Tested by
Item
Alcohol urine test, Tested by
text
C0202304 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,3])
Item Group
Drugs of Abuse Screen
C0038577 (UMLS CUI-1)
Date of sample
Item
Date of sample taken
date
C1302413 (UMLS CUI [1])
Item
Opiates
text
C0376196 (UMLS CUI [1])
Code List
Opiates
CL Item
Positive (P)
CL Item
Negative (N)
Item
Cocaine
text
C0009170 (UMLS CUI [1])
Code List
Cocaine
CL Item
Positive (P)
CL Item
Negative (N)
Item
Barbiturates
text
C0004745 (UMLS CUI [1])
Code List
Barbiturates
CL Item
Positive (P)
CL Item
Negative (N)
Item
Amphetamines
text
C0002667 (UMLS CUI [1])
Code List
Amphetamines
CL Item
Positive (P)
CL Item
Negative (N)
Item
Benzodiazepines
text
C0005064 (UMLS CUI [1])
Code List
Benzodiazepines
CL Item
Positive (P)
CL Item
Negative (N)
Item
Cannabis
text
C0936079 (UMLS CUI [1])
Code List
Cannabis
CL Item
Positive (P)
CL Item
Negative (N)

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