ID
32978
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 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)
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Rechteinhaber
GlaxoSmithKline
Hochgeladen am
22. November 2018
DOI
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Lizenz
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
Beschreibung
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Beschreibung
Date of comment
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0011008
Beschreibung
CRF page number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C1516308
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Investigator’s Statement
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1710187
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
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Investigator’s signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator’s name - print
Datentyp
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)