ID

33027

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 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).

Keywords

  1. 11/22/18 11/22/18 -
  2. 11/22/18 11/22/18 -
  3. 11/23/18 11/23/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 23, 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

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

Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Session Number
Description

Session Number

Data type

integer

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

End of Study Record

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

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.

Data type

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
Description

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.

Data type

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?
Description

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.

Data type

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?
Description

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.

Data type

text

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

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

Data type

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.
Description

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

Data type

text

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

Other reason

Data type

text

Alias
UMLS CUI [1]
C3840932
Investigator Comment Log
Description

Investigator Comment Log

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

Date of comment

Data type

date

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

CRF page number

Data type

integer

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

Comment

Data type

text

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

Investigator’s Statement

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

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.

Data type

boolean

Alias
UMLS CUI [1]
C0750484
Date
Description

day month year

Data type

date

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

Investigator’s signature

Data type

text

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

Investigator’s name - print

Data type

text

Alias
UMLS CUI [1]
C2826892

Similar models

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

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
Session Number
integer
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
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])
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])
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])
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])
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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