ID

29555

Descripción

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: IP Device Malfunction

Palabras clave

Versiones (2)
  1. 15.03.18 15.03.18 -
  2. 05.04.18 05.04.18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

5. April 2018

DOI

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Licencia

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

Inglés

IP Device Malfunction

1 formularios  
  1. StudyEvent: ODM
    1. IP Device Malfunction
IP Device Malfunction
Descripción

IP Device Malfunction

Alias
UMLS CUI-1
C1881681
Investigational product container number
Descripción

Investigational product container number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Date of Device Malfunction
Descripción

Date of Device Malfunction

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1881681
UMLS CUI [1,2]
C0011008
Time of Device Malfunction
Descripción

Time of Device Malfunction

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1881681
UMLS CUI [1,2]
C0040223
Mark all applicable reasons for device malfunction
Descripción

Device Malfunction reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1881681
UMLS CUI [1,2]
C0392360
Other Device Malfunction reason, specify
Descripción

Device Malfunction reason

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1881681
UMLS CUI [1,2]
C0392360
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Similar models

IP Device Malfunction

1 formularios
  1. StudyEvent: ODM
    1. IP Device Malfunction
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
IP Device Malfunction
C1881681 (UMLS CUI-1)
Investigational product container number
Item
Investigational product container number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Date of Device Malfunction
Item
Date of Device Malfunction
date
C1881681 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Device Malfunction
Item
Time of Device Malfunction
time
C1881681 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Mark all applicable reasons for device malfunction
integer
C1881681 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Device Malfunction reason
Code List
Mark all applicable reasons for device malfunction
CL Item
Mouthpiece Cover does not stay at the fully actuated position (1)
CL Item
Mouthpiece cover came apart rrom the mechanism (2)
CL Item
Inhaler is cracked or broken apart (3)
CL Item
Difficult to open mouthpiece cover/force to actuate was too high (4)
CL Item
Difficult to close mouthpiece cover (5)
CL Item
Powder fell out prior to use (6)
CL Item
No powder came out (7)
CL Item
Device squeaks In operation (8)
CL Item
Device rattles in operation (9)
CL Item
Dose counter did not count (10)
CL Item
Dose counter is ambiguous (11)
CL Item
Dose counter overcounted (12)
CL Item
Dose counter undercounted (13)
CL Item
Difficult to pull air through the device as described in the leaflet (14)
CL Item
Device smelt/bad odour when pack opened (15)
CL Item
Other, specify (16)
Device Malfunction reason
Item
Other Device Malfunction reason, specify
text
C1881681 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
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