ID

32962

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 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.

Keywords

Versions (4)
  1. 11/13/18 11/13/18 -
  2. 11/16/18 11/16/18 -
  3. 11/22/18 11/22/18 -
  4. 11/22/18 11/22/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 22, 2018

DOI

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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

Alcohol urine test, Drug screen.

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
Screening/ Treatment Period Number
Description

Screening/ Treatment Period Number

Data type

integer

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

Alcohol Urine Test

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

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Alcohol urine test
Description

If it's positive, EXCLUDE subject from the study

Data type

text

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

Note the Initials

Data type

text

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

Drugs of Abuse Screen

Alias
UMLS CUI-1
C0038577
Date of sample taken
Description

Date of sample

Data type

date

Alias
UMLS CUI [1]
C1302413
Opiates
Description

If positive, EXCLUDE subject from the study.

Data type

text

Alias
UMLS CUI [1]
C0376196
Cocaine
Description

If positive, EXCLUDE subject from the study.

Data type

text

Alias
UMLS CUI [1]
C0009170
Barbiturates
Description

If positive, EXCLUDE subject from the study.

Data type

text

Alias
UMLS CUI [1]
C0004745
Amphetamines
Description

If positive, EXCLUDE subject from the study.

Data type

text

Alias
UMLS CUI [1]
C0002667
Benzodiazepines
Description

If positive, EXCLUDE subject from the study.

Data type

text

Alias
UMLS CUI [1]
C0005064
Cannabis
Description

If positive, EXCLUDE subject from the study.

Data type

text

Alias
UMLS CUI [1]
C0936079
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Similar models

Alcohol urine test, Drug screen.

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])
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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