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).
Mots-clés
Versions (3)
- 22/11/2018 22/11/2018 -
- 22/11/2018 22/11/2018 -
- 23/11/2018 23/11/2018 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
23 novembre 2018
DOI
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Licence
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
- StudyEvent: ODM
Description
End of Study Record
Alias
- UMLS CUI-1
- C0008976
- UMLS CUI-2
- C0444930
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.
Type de données
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
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.
Type de données
time
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [2,1]
- C0457454
- UMLS CUI [2,2]
- C0040223
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.
Type de données
text
Alias
- UMLS CUI [1]
- C0032961
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.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0025080
- UMLS CUI [1,2]
- C1551358
Description
Subjects who complete all study visits (screening, all treatment periods and follow-up) will be considered as having completed the study.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0008976
Description
Tick one. If A: Record details on NON-SERIOUS ADVERSE EVENTS or SERIOUS ADVERSE EVENT page as appropriate.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C0008976
Description
Other reason
Type de données
text
Alias
- UMLS CUI [1]
- C3840932
Description
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Description
Date of comment
Type de données
date
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0011008
Description
CRF page number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C1516308
Description
Comment
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
Investigator’s Statement
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1710187
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.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0750484
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Description
Investigator’s signature
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator’s name - print
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
End of study, Investigator Comment Log, Investigator’s Statement
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0457454 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0011008 (UMLS CUI [2,3])
C0040223 (UMLS CUI [1,2])
C0457454 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C1551358 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0947611 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C1516308 (UMLS CUI [1,2])
C1710187 (UMLS CUI-2)