ID

29550

Descrição

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: LOGS and Repeats

Palavras-chave

Versões (2)
  1. 10/03/2018 10/03/2018 -
  2. 05/04/2018 05/04/2018 -
Titular dos direitos

GlaxoSmithKline

Transferido a

5 de abril de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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GSK Dose proportionality of fluticasone furoate and equivalence of vilanterol in healthy adults NCT01213849

Inglês

LOGS and Repeats

1 Formulários  
  1. StudyEvent: ODM
    1. LOGS and Repeats
ADVERSE EVENT/CONCOMITANT MEDICATION/REPEAT ASSESSMENT CHECK QUESTIONS
Descrição

ADVERSE EVENT/CONCOMITANT MEDICATION/REPEAT ASSESSMENT CHECK QUESTIONS

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0877248
UMLS CUI-3
C0008976
UMLS CUI-4
C1320722
Date of visit/assessment
Descrição

Date of visit/assessment

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Were any concomitant medications taken by the subject during the study?
Descrição

concomitant medications

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience any non-serious adverse events during the study?
Descrição

non-serious adverse events

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1518404
Did the subject experience any serious adverse events during the study?
Descrição

serious adverse events

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1519255
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Descrição

abnormal ECG

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0522055
Were any repeat haematology or clinical chemistry samples taken?
Descrição

repeat haematology or clinical chemistry samples taken

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0200345
Were any repeat urinalysis samples taken?
Descrição

urinalysis samples

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
Were any repeat ECGs performed?
Descrição

ECG

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013798
Were any repeat vital signs recorded?
Descrição

vital signs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518766
Were any repeat Pulmonary Function Tests performed?
Descrição

Pulmonary Function Tests

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024119
Were any repeat PK blood samples taken?
Descrição

PK blood samples taken

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
Any IP device malfunctions?
Descrição

IP device malfunctions

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0699733
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Descrição

liver chemistry

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
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Similar models

LOGS and Repeats

1 Formulários
  1. StudyEvent: ODM
    1. LOGS and Repeats
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
ADVERSE EVENT/CONCOMITANT MEDICATION/REPEAT ASSESSMENT CHECK QUESTIONS
C2347852 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
C1320722 (UMLS CUI-4)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
concomitant medications
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
non-serious adverse events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
serious adverse events
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
abnormal ECG
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
boolean
C0522055 (UMLS CUI [1])
repeat haematology or clinical chemistry samples taken
Item
Were any repeat haematology or clinical chemistry samples taken?
boolean
C0008000 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
urinalysis samples
Item
Were any repeat urinalysis samples taken?
boolean
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
ECG
Item
Were any repeat ECGs performed?
boolean
C0013798 (UMLS CUI [1])
vital signs
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1])
Pulmonary Function Tests
Item
Were any repeat Pulmonary Function Tests performed?
boolean
C0024119 (UMLS CUI [1])
PK blood samples taken
Item
Were any repeat PK blood samples taken?
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
IP device malfunctions
Item
Any IP device malfunctions?
boolean
C0699733 (UMLS CUI [1])
liver chemistry
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
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