ID

33000

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 form for pharmacokinetic blood sampling,investigational products and their administration. It has to be filled in for session 2-6.

Trefwoorden

Versies (3)
  1. 15-11-18 15-11-18 -
  2. 22-11-18 22-11-18 -
  3. 23-11-18 23-11-18 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

23 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

Engels

Pharmacokinetic Blood Sampling, lnvestigational Product

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Session Number
Beschrijving

Session Number

Datatype

integer

Alias
UMLS CUI [1,1]
C1883017
UMLS CUI [1,2]
C0750480
Pharmacokinetic Blood Sampling
Beschrijving

Pharmacokinetic Blood Sampling

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0870078
Row no.
Beschrijving

Row no.

Datatype

integer

Alias
UMLS CUI [1]
C0237753
Date of Pharmacokinetic Blood Sampling
Beschrijving

day month year.

Datatype

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Planned relative time
Beschrijving

time relative to dosing

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Actual time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample number
Beschrijving

Sample number

Datatype

integer

Alias
UMLS CUI [1]
C1299222
FP (fluticasone propionate) sample taken
Beschrijving

Tick if taken. Please take for sample number BLD001, BLD003-BLD013. It does not have to be taken for sample number BLD002.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0117996
UMLS CUI [1,2]
C0200345
SALM (salmeterol) sample taken
Beschrijving

Tick if taken. Please take for sample number BLD001-BLD006 and BLD008. It does not have to be taken for: BLD007, BLD009-BLD013

Datatype

boolean

Alias
UMLS CUI [1,1]
C0073992
UMLS CUI [1,2]
C0200345
lnvestigational Product
Beschrijving

lnvestigational Product

Alias
UMLS CUI-1
C0304229
Date of dose
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of dose
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Number of inhalations
Beschrijving

Number of inhalations

Datatype

integer

Alias
UMLS CUI [1,1]
C0354922
UMLS CUI [1,2]
C0237753
Were there any significant changes to investigational product?
Beschrijving

Significant changes refer to investigational product not administered as per the requirements of the protocol.

Datatype

text

Alias
UMLS CUI [1,1]
C3845681
UMLS CUI [1,2]
C0304229
If Significant changes to investigational product, specify investigational product changes, dates, and reasons
Beschrijving

Specify investigational product change

Datatype

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C3845681
UMLS CUI [1,3]
C0304229
lnvestigational Product Administration Worksheet
Beschrijving

lnvestigational Product Administration Worksheet

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1533734
Investigational product
Beschrijving

Tick appropriate box(es). Each participant of the study will use each of the 5 application methods in the course of the study. Which method will be used during which treatment period is determined by randomization.

Datatype

text

Alias
UMLS CUI [1]
C0304229
lnvestigational product: Given by
Beschrijving

initials

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0027361
UMLS CUI [1,3]
C1533734
lnvestigational product: Checked by
Beschrijving

initials

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1621583
UMLS CUI [1,3]
C1283174
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Similar models

Pharmacokinetic Blood Sampling, lnvestigational Product

1 Formulieren
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
Session Number
integer
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Session Number
Code List
Session Number
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
Item Group
Pharmacokinetic Blood Sampling
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0870078 (UMLS CUI-3)
Item
Row no.
integer
C0237753 (UMLS CUI [1])
Row no.
Code List
Row no.
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
Date of Pharmacokinetic Blood Sampling
Item
Date of Pharmacokinetic Blood Sampling
date
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
Planned relative time
integer
C0439564 (UMLS CUI [1])
Planned relative time
Code List
Planned relative time
CL Item
Pre-dose (1)
CL Item
5mins (2)
CL Item
10mins (3)
CL Item
30mins (4)
CL Item
45mins (5)
CL Item
1hr (6)
CL Item
1,5hrs (7)
CL Item
2hrs (8)
CL Item
4hrs  (9)
CL Item
6hrs (10)
CL Item
8hrs (11)
CL Item
10 hrs (12)
CL Item
12hrs (13)
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Item
Sample number
integer
C1299222 (UMLS CUI [1])
Sample number
Code List
Sample number
CL Item
BLD001 (1)
CL Item
BLD002 (2)
CL Item
BLD003 (3)
CL Item
BLD004 (4)
CL Item
BLD005 (5)
CL Item
BLD006 (6)
CL Item
BLD007 (7)
CL Item
BLD008 (8)
CL Item
BLD009 (9)
CL Item
BLD010 (10)
CL Item
BLD011 (11)
CL Item
BLD012 (12)
CL Item
BLD013 (13)
Fluticasone propionate sample
Item
FP (fluticasone propionate) sample taken
boolean
C0117996 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Salmeterol sample
Item
SALM (salmeterol) sample taken
boolean
C0073992 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item Group
lnvestigational Product
C0304229 (UMLS CUI-1)
Date of dose
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of dose
Item
Time of dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Number of inhalations
Item
Number of inhalations
integer
C0354922 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Were there any significant changes to investigational product?
text
C3845681 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Significant changes to investigational product
Code List
Were there any significant changes to investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Specify investigational product change
Item
If Significant changes to investigational product, specify investigational product changes, dates, and reasons
text
C1521902 (UMLS CUI [1,1])
C3845681 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item Group
lnvestigational Product Administration Worksheet
C0304229 (UMLS CUI-1)
C1533734 (UMLS CUI-2)
Item
Investigational product
text
C0304229 (UMLS CUI [1])
Investigational product
Code List
Investigational product
CL Item
HFA MDI without spacer (A)
CL Item
HFA MDI with Aerochamber - Plus spacer (B)
CL Item
HFA MDI with VOLUMATIC spacer (D)
CL Item
DISKUS/ACCUHALER (E)
CL Item
HFA MDI with Aerochamber- Max spacer (C)
lnvestigational product: Given by
Item
lnvestigational product: Given by
text
C0304229 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,3])
lnvestigational product: Checked by
Item
lnvestigational product: Checked by
text
C0304229 (UMLS CUI [1,1])
C1621583 (UMLS CUI [1,2])
C1283174 (UMLS CUI [1,3])
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