ID
32978
Beskrivning
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).
Nyckelord
Versioner (3)
- 2018-11-22 2018-11-22 -
- 2018-11-22 2018-11-22 -
- 2018-11-23 2018-11-23 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
22 november 2018
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
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
Beskrivning
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Beskrivning
Date of comment
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0011008
Beskrivning
CRF page number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C1516308
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Investigator’s Statement
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1710187
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0750484
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Investigator’s signature
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator’s name - print
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
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)