ID

32963

Beschreibung

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.

Stichworte

Versionen (4)
  1. 13/11/2018 13/11/2018 -
  2. 16/11/2018 16/11/2018 -
  3. 22/11/2018 22/11/2018 -
  4. 22/11/2018 22/11/2018 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

22 novembre 2018

DOI

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Lizenz

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

Englisch

Alcohol urine test, Drug screen.

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

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

Screening/ Treatment Period Number

Datentyp

integer

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

Alcohol Urine Test

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

Date sample taken

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Alcohol urine test
Beschreibung

If it's positive, EXCLUDE subject from the study

Datentyp

text

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

Note the Initials

Datentyp

text

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

Drugs of Abuse Screen

Alias
UMLS CUI-1
C0038577
Date of sample taken
Beschreibung

Date of sample

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Opiates
Beschreibung

If positive, EXCLUDE subject from the study.

Datentyp

text

Alias
UMLS CUI [1]
C0376196
Cocaine
Beschreibung

If positive, EXCLUDE subject from the study.

Datentyp

text

Alias
UMLS CUI [1]
C0009170
Barbiturates
Beschreibung

If positive, EXCLUDE subject from the study.

Datentyp

text

Alias
UMLS CUI [1]
C0004745
Amphetamines
Beschreibung

If positive, EXCLUDE subject from the study.

Datentyp

text

Alias
UMLS CUI [1]
C0002667
Benzodiazepines
Beschreibung

If positive, EXCLUDE subject from the study.

Datentyp

text

Alias
UMLS CUI [1]
C0005064
Cannabis
Beschreibung

If positive, EXCLUDE subject from the study.

Datentyp

text

Alias
UMLS CUI [1]
C0936079
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Ähnliche Modelle

Alcohol urine test, Drug screen.

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Session Number
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])
Alcohol urine test
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])
Opiates
Code List
Opiates
CL Item
Positive (P)
CL Item
Negative (N)
Item
Cocaine
text
C0009170 (UMLS CUI [1])
Opiates
Code List
Cocaine
CL Item
Positive (P)
CL Item
Negative (N)
Item
Barbiturates
text
C0004745 (UMLS CUI [1])
Opiates
Code List
Barbiturates
CL Item
Positive (P)
CL Item
Negative (N)
Item
Amphetamines
text
C0002667 (UMLS CUI [1])
Amphetamines
Code List
Amphetamines
CL Item
Positive (P)
CL Item
Negative (N)
Item
Benzodiazepines
text
C0005064 (UMLS CUI [1])
Amphetamines
Code List
Benzodiazepines
CL Item
Positive (P)
CL Item
Negative (N)
Item
Cannabis
text
C0936079 (UMLS CUI [1])
Amphetamines
Code List
Cannabis
CL Item
Positive (P)
CL Item
Negative (N)
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