ID
33000
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 form for pharmacokinetic blood sampling,investigational products and their administration. It has to be filled in for session 2-6.
Mots-clés
Versions (3)
- 15/11/2018 15/11/2018 -
- 22/11/2018 22/11/2018 -
- 23/11/2018 23/11/2018 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
23 novembre 2018
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877
Pharmacokinetic Blood Sampling, lnvestigational Product
- StudyEvent: ODM
Description
Pharmacokinetic Blood Sampling
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
- UMLS CUI-3
- C0870078
Description
Row no.
Type de données
integer
Alias
- UMLS CUI [1]
- C0237753
Description
day month year.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
Description
time relative to dosing
Type de données
integer
Alias
- UMLS CUI [1]
- C0439564
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1]
- C0040223
Description
Sample number
Type de données
integer
Alias
- UMLS CUI [1]
- C1299222
Description
Tick if taken. Please take for sample number BLD001, BLD003-BLD013. It does not have to be taken for sample number BLD002.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0117996
- UMLS CUI [1,2]
- C0200345
Description
Tick if taken. Please take for sample number BLD001-BLD006 and BLD008. It does not have to be taken for: BLD007, BLD009-BLD013
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0073992
- UMLS CUI [1,2]
- C0200345
Description
lnvestigational Product
Alias
- UMLS CUI-1
- C0304229
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Description
Number of inhalations
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0354922
- UMLS CUI [1,2]
- C0237753
Description
Significant changes refer to investigational product not administered as per the requirements of the protocol.
Type de données
text
Alias
- UMLS CUI [1,1]
- C3845681
- UMLS CUI [1,2]
- C0304229
Description
Specify investigational product change
Type de données
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C3845681
- UMLS CUI [1,3]
- C0304229
Description
lnvestigational Product Administration Worksheet
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C1533734
Description
Tick appropriate box(es). Each participant of the study will use each of the 5 application methods in the course of the study. Which method will be used during which treatment period is determined by randomization.
Type de données
text
Alias
- UMLS CUI [1]
- C0304229
Description
initials
Type de données
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0027361
- UMLS CUI [1,3]
- C1533734
Description
initials
Type de données
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1621583
- UMLS CUI [1,3]
- C1283174
Similar models
Pharmacokinetic Blood Sampling, lnvestigational Product
- StudyEvent: ODM
C0005767 (UMLS CUI-2)
C0870078 (UMLS CUI-3)
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C3845681 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1533734 (UMLS CUI-2)
C0027361 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,3])
C1621583 (UMLS CUI [1,2])
C1283174 (UMLS CUI [1,3])