ID
29549
Beschrijving
Study ID: 102932 Clinical Study ID: HZA102932 Study Title:An open-label, randomised, 3-way crossover single dose study to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) when administered as FF/VI inhalation powder from the novel dry powder inhaler in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01213849 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma Documentation part: Follow-up
Trefwoorden
Versies (2)
- 10-03-18 10-03-18 -
- 05-04-18 05-04-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
5 april 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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GSK Dose proportionality of fluticasone furoate and equivalence of vilanterol in healthy adults NCT01213849
Follow-up
- StudyEvent: ODM
Beschrijving
Electronically Transferred Lab Data (D-1 Lab)
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0022885
- UMLS CUI-3
- C1320722
Beschrijving
Haematology sample taken
Datatype
boolean
Alias
- UMLS CUI [1]
- C1277698
Beschrijving
Date Haematology sample taken
Datatype
date
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C1302413
Beschrijving
Time Haematology sample taken
Datatype
time
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0040223
Beschrijving
Clinical Chemistry Sample taken
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0008000
Beschrijving
Clinical Chemistry Sample same as the Haematology sample
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0008000
Beschrijving
Date Clinical Chemistry Sample taken
Datatype
date
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0011008
Beschrijving
Time Clinical Chemistry Sample taken
Datatype
time
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0040223
Beschrijving
Urinalysis done
Datatype
boolean
Alias
- UMLS CUI [1]
- C0042014
Beschrijving
Date Urinalysis sample taken
Datatype
date
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0011008
Beschrijving
Time Urinalysis sample taken
Datatype
time
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0040223
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Actual date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
Beschrijving
Actual time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0040223
Beschrijving
Blood pressure systolic
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Blood pressure diastolic
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
12-lead ECG
Alias
- UMLS CUI-1
- C1623258
- UMLS CUI-2
- C0430456
Beschrijving
Date of ECG
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Beschrijving
Time of ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0040223
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0430456
Beschrijving
PR Interval
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0429025
- UMLS CUI [1,2]
- C0430456
Beschrijving
Uncorrected QT Interval
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C1287082
- UMLS CUI [1,2]
- C0430456
Beschrijving
QTcF Interval
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C1882513
Beschrijving
Method of QTc Calculation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
QTcB (Bazett)
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C0855331
Beschrijving
Result of the ECG
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0438154
- UMLS CUI [1,2]
- C0430456
Beschrijving
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
Beschrijving
If yes, please complete the paper Pregnancy Notification form.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0032961
Beschrijving
female partner of the male subject become pregnant
Datatype
text
Alias
- UMLS CUI [1]
- C0919624
Similar models
Follow-up
- StudyEvent: ODM
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C1302413 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C1882513 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])