ID
29549
Description
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
Keywords
Versions (2)
- 3/10/18 3/10/18 -
- 4/5/18 4/5/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 5, 2018
DOI
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License
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
Description
Electronically Transferred Lab Data (D-1 Lab)
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0022885
- UMLS CUI-3
- C1320722
Description
Haematology sample taken
Data type
boolean
Alias
- UMLS CUI [1]
- C1277698
Description
Date Haematology sample taken
Data type
date
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C1302413
Description
Time Haematology sample taken
Data type
time
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0040223
Description
Clinical Chemistry Sample taken
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0008000
Description
Clinical Chemistry Sample same as the Haematology sample
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0008000
Description
Date Clinical Chemistry Sample taken
Data type
date
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0011008
Description
Time Clinical Chemistry Sample taken
Data type
time
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0040223
Description
Urinalysis done
Data type
boolean
Alias
- UMLS CUI [1]
- C0042014
Description
Date Urinalysis sample taken
Data type
date
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0011008
Description
Time Urinalysis sample taken
Data type
time
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0040223
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Actual date
Data type
date
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
Description
Actual time
Data type
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0040223
Description
Blood pressure systolic
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Blood pressure diastolic
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
12-lead ECG
Alias
- UMLS CUI-1
- C1623258
- UMLS CUI-2
- C0430456
Description
Date of ECG
Data type
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Description
Time of ECG
Data type
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0040223
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0430456
Description
PR Interval
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0429025
- UMLS CUI [1,2]
- C0430456
Description
Uncorrected QT Interval
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C1287082
- UMLS CUI [1,2]
- C0430456
Description
QTcF Interval
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C1882513
Description
Method of QTc Calculation
Data type
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
QTcB (Bazett)
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C0855331
Description
Result of the ECG
Data type
integer
Alias
- UMLS CUI [1,1]
- C0438154
- UMLS CUI [1,2]
- C0430456
Description
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
Description
If yes, please complete the paper Pregnancy Notification form.
Data type
boolean
Alias
- UMLS CUI [1]
- C0032961
Description
female partner of the male subject become pregnant
Data type
text
Alias
- UMLS CUI [1]
- C0919624
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Follow-up
- StudyEvent: ODM
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C0022885 (UMLS CUI-2)
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