ID

32938

Descrição

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 Worksheet for concomitant Medications. It has to be filled in for screening and during study if a concomitant medication is given.

Palavras-chave

Versões (2)
  1. 16/11/2018 16/11/2018 -
  2. 21/11/2018 21/11/2018 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

21 de novembro de 2018

DOI

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Licença

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

Inglês

Concomitant Medications

1 Formulários  
Administrative data
Descrição

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Descrição

Subject number

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Concomitant Medications
Descrição

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject during the study?
Descrição

If NO is ticked, check that no concomitant medications are present. If YES is ticked, check that at least one concomitant medication is present. If YES, record columne below

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1883727
Drug name
Descrição

(Trade name preferred) If medication is given to treat an adverse event, then the ADVERSE EVENT must be recorded on the NON-SERIOUS ADVERSE EVENT or SERIOUS ADVERSE EVENT page(s) at the back of the CRF.

Tipo de dados

text

Alias
UMLS CUI [1]
C2360065
Drug Dose
Descrição

Commonly used abbreviations are acceptable.

Tipo de dados

integer

Alias
UMLS CUI [1]
C0678766
Unit of drug dose
Descrição

Commonly used abbreviations are acceptable.

Tipo de dados

text

Alias
UMLS CUI [1]
C2826646
Drug Frequency
Descrição

Commonly used abbreviations are acceptable.

Tipo de dados

text

Alias
UMLS CUI [1]
C3476109
Route
Descrição

Commonly used abbreviations are acceptable.

Tipo de dados

text

Alias
UMLS CUI [1]
C0013153
Date started
Descrição

day month year. Check that the drug start date is before or equal to the drug stop date, if a stop date has been entered. Partial dates are acceptable. Check that either the ‘Date started’ is completed or ‘Tick if started pre-study’ is ticked. At least one must be completed, but it is acceptable if both are completed. If a pre-investigational product start date is unknown, check that a tick is recorded for ‘tick if started Pre-study’. If both ‘Date started’ and ‘Tick if started Pre-study’ are completed, check that the start date is pre-study.

Tipo de dados

partialDate

Alias
UMLS CUI [1]
C0808070
If Started Pre-Study, tick
Descrição

Started Pre-Study

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0008976
Start time
Descrição

00:00-23:59 For single dose, start and stop times may be the same.

Tipo de dados

time

Alias
UMLS CUI [1]
C1301880
Date stopped
Descrição

day month year Record the stop date if concomitant medication is stopped prior to the end of the study.

Tipo de dados

date

Alias
UMLS CUI [1]
C0806020
If continued Post-Study, tick
Descrição

Continuing Post-Study

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0444930
Stop time
Descrição

00:00-23:59 For single dose, start and stop times may be the same.

Tipo de dados

time

Alias
UMLS CUI [1]
C1522314
Conditions treated/ indication
Descrição

Conditions treated/ indication

Tipo de dados

text

Alias
UMLS CUI [1]
C2826696
Was drug-administered for an adverse event?
Descrição

If the concomitant medication was taken for an adverse event, check that the event is entered on the appropriate ADVERSE EVENTS page(s) and that the dates are consistent with the event.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0877248
Was drug-administered as a rescue medication?
Descrição

Rescue medication

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0884980
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Similar models

Concomitant Medications

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Item
Were any concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1,1])
C1883727 (UMLS CUI [1,2])
Concomitant medications taken
Code List
Were any concomitant medications taken by the subject during the study?
CL Item
Yes (Y)
CL Item
No (N)
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Drug Dose
Item
Drug Dose
integer
C0678766 (UMLS CUI [1])
Dose unit
Item
Unit of drug dose
text
C2826646 (UMLS CUI [1])
Drug Frequency
Item
Drug Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Date started
Item
Date started
partialDate
C0808070 (UMLS CUI [1])
Started Pre-Study
Item
If Started Pre-Study, tick
boolean
C2347852 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
Date stopped
Item
Date stopped
date
C0806020 (UMLS CUI [1])
Continuing Post-Study
Item
If continued Post-Study, tick
boolean
C0549178 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
Stop time
Item
Stop time
time
C1522314 (UMLS CUI [1])
Conditions treated/ indication
Item
Conditions treated/ indication
text
C2826696 (UMLS CUI [1])
Item
Was drug-administered for an adverse event?
text
C0013227 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Drug adminstration for AE
Code List
Was drug-administered for an adverse event?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was drug-administered as a rescue medication?
text
C0013227 (UMLS CUI [1,1])
C0884980 (UMLS CUI [1,2])
Rescue medication
Code List
Was drug-administered as a rescue medication?
CL Item
Yes (Y)
CL Item
No (N)
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