ID
32978
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 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).
Trefwoorden
Versies (3)
- 22-11-18 22-11-18 -
- 22-11-18 22-11-18 -
- 23-11-18 23-11-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
22 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
Investigator Comment Log, Investigator’s Statement
- StudyEvent: ODM
Beschrijving
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Beschrijving
Date of comment
Datatype
date
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0011008
Beschrijving
CRF page number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C1516308
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Investigator’s Statement
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1710187
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0750484
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Investigator’s signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator’s name - print
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
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Investigator Comment Log, Investigator’s Statement
- StudyEvent: ODM
C0947611 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C1516308 (UMLS CUI [1,2])
C1710187 (UMLS CUI-2)