ID

33027

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 end of study, Investigator Comment Log and Investigator’s Statement form. It has to be filled in at the end of study (after all relevant CRF pages, including outstanding test results, are completed).

Stichworte

Versionen (3)
  1. 22.11.18 22.11.18 -
  2. 22.11.18 22.11.18 -
  3. 23.11.18 23.11.18 -
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GlaxoSmithKline

Hochgeladen am

23. November 2018

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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

End of study, Investigator Comment Log, Investigator’s Statement

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Session Number
Beschreibung

Session Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1883017
UMLS CUI [1,2]
C0750480
End of Study Record
Beschreibung

End of Study Record

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C0444930
Date of subject completion or discontinuation from the study
Beschreibung

day month year. Check that the "Date of subject completion or discontinuation from the study" is on or after the last treatment stop date on the INVESTIGATIONAL PRODUCT page.

Datentyp

date

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0457454
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0011008
Time of subject completion or discontinuation from the study
Beschreibung

00:00-23:59. Check that the "Time of subject completion or discontinuation from the study" is the same as or after the time of last treatment dose (if applicable) on the INVEST/GA TIONAL PRODUCT page if present.

Datentyp

time

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C0457454
UMLS CUI [2,2]
C0040223
Did the subject become pregnant during the study?
Beschreibung

Tick one. This question must be answered for all subjects. For females not of childbearing potential or males, tick NOT APPLICABLE. If no pregnancy was known before a subject was lost to follow-up, tick NO. If the subject became pregnant before either premature discontinuation from the study or completion of the study, tick YES. If you tick YES, record details on PREGNANCY NOTIFICATION FORM.

Datentyp

text

Alias
UMLS CUI [1]
C0032961
Did the subject experience an incident or near incident with GlaxoSmithKline medical devices provided for use during the study?
Beschreibung

The medical devices being used in this study are the VOLUMATIC spacers. If a subject never used this/these device(s), tick NO. If no incident was known before a subject was lost to follow-up, tick NO. If an incident occurred before either premature discontinuation from the study or completion of the study, tick YES. If you tick YES, record details on the MEDICAL DEVICE INCIDENT REPORT FORM.

Datentyp

text

Alias
UMLS CUI [1,1]
C0025080
UMLS CUI [1,2]
C1551358
Did the subject discontinue the study prematurely?
Beschreibung

Subjects who complete all study visits (screening, all treatment periods and follow-up) will be considered as having completed the study.

Datentyp

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0008976
If you tick yes in "Discontinuation of study", tick the primary reason for discontinuation.
Beschreibung

Tick one. If A: Record details on NON-SERIOUS ADVERSE EVENTS or SERIOUS ADVERSE EVENT page as appropriate.

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
If other reason, please specify
Beschreibung

Other reason

Datentyp

text

Alias
UMLS CUI [1]
C3840932
Investigator Comment Log
Beschreibung

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
Date of comment
Beschreibung

Date of comment

Datentyp

date

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0011008
CRF page number if applicable
Beschreibung

CRF page number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Investigator’s Statement
Beschreibung

Investigator’s Statement

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1710187
Confirmation
Beschreibung

I confirm that I have carefully examined all entries on the Screening Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.

Datentyp

boolean

Alias
UMLS CUI [1]
C0750484
Date
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Investigator’s signature
Beschreibung

Investigator’s signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator’s name - print
Beschreibung

Investigator’s name - print

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

End of study, Investigator Comment Log, Investigator’s Statement

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
Session Number
integer
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Session Number
Code List
Session Number
CL Item
Session 1 (1)
CL Item
Session 2 (2)
CL Item
Session 3 (3)
CL Item
Session 4 (4)
CL Item
Session 5 (5)
CL Item
Session 6 (6)
Item Group
End of Study Record
C0008976 (UMLS CUI-1)
C0444930 (UMLS CUI-2)
Date of subject completion or discontinuation from the study
Item
Date of subject completion or discontinuation from the study
date
C2348577 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0457454 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0011008 (UMLS CUI [2,3])
Time of subject completion or discontinuation from the study
Item
Time of subject completion or discontinuation from the study
time
C2348577 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0457454 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1])
Pregnancy
Code List
Did the subject become pregnant during the study?
CL Item
Not applicable (Not of childbearing potential or male) (X)
CL Item
Yes  (Y)
CL Item
No (N)
Item
Did the subject experience an incident or near incident with GlaxoSmithKline medical devices provided for use during the study?
text
C0025080 (UMLS CUI [1,1])
C1551358 (UMLS CUI [1,2])
Incident or near incident with GlaxoSmithKline medical devices
Code List
Did the subject experience an incident or near incident with GlaxoSmithKline medical devices provided for use during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the subject discontinue the study prematurely?
text
C0457454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Discontinuation of study
Code List
Did the subject discontinue the study prematurely?
CL Item
Yes (Y)
CL Item
No (N)
Item
If you tick yes in "Discontinuation of study", tick the primary reason for discontinuation.
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Discontinuation of study, reason
Code List
If you tick yes in "Discontinuation of study", tick the primary reason for discontinuation.
CL Item
Adverse event (A)
CL Item
Consent withdrawn (C)
CL Item
Lost to follow up (L)
CL Item
Protocol violation (P)
CL Item
Other (X)
Other reason
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1])
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Date of comment
Item
Date of comment
date
C0947611 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
CRF page number
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator’s Statement
C0008961 (UMLS CUI-1)
C1710187 (UMLS CUI-2)
Confirmation
Item
Confirmation
boolean
C0750484 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigator’s signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Investigator’s name - print
Item
Investigator’s name - print
text
C2826892 (UMLS CUI [1])
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