ID

33998

Descrição

Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 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 The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the IP Device Malfunction (IPDEVMAL) form. It has to be filled in for repeat if required.

Link

https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026

Palavras-chave

Versões (2)
  1. 09/01/2019 09/01/2019 -
  2. 10/01/2019 10/01/2019 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

10 de janeiro de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

Inglês

IP Device Malfunction (IPDEVMAL)

1 Formulários  
Administrative data
Descrição

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Descrição

Subject number

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
IP Device Malfunction (IPDEVMAl)
Descrição

IP Device Malfunction (IPDEVMAl)

Alias
UMLS CUI-1
C1881681
lnvestigational product container number
Descrição

lnvestigational product container number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Reasons for device malfunction
Descrição

Reasons for device malfunction

Alias
UMLS CUI-1
C1881681
UMLS CUI-2
C0566251
Mouthpiece Cover does not stay at the fully actuated position
Descrição

Mouthpiece Cover, position

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0725867
UMLS CUI [1,2]
C3888055
UMLS CUI [1,3]
C1550045
Mouthpiece Cover came apart from the mechanism
Descrição

Mouthpiece cover detached

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0725867
UMLS CUI [1,2]
C3888055
UMLS CUI [1,3]
C0687118
Inhaler is cracked or broken apart
Descrição

Inhaler cracked or broken apart

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021461
UMLS CUI [1,2]
C1706353
Difficult to open mouthpiece cover/ force to actuate was too high
Descrição

Difficult to open mouthpiece cover

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0725867
UMLS CUI [1,2]
C3888055
UMLS CUI [1,3]
C0332218
UMLS CUI [1,4]
C0175566
Difficult to close mouthpiece cover
Descrição

Difficult to close mouthpiece cover

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0725867
UMLS CUI [1,2]
C3888055
UMLS CUI [1,3]
C0332218
UMLS CUI [1,4]
C3810854
Powder fell lost prior to use
Descrição

Powder fell lost prior to use

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0991575
UMLS CUI [1,2]
C0745777
No powder came out (Emission substance)
Descrição

No powder came out (Emission substance)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0991575
UMLS CUI [1,3]
C2349995
No Device squeaks in operation
Descrição

No Device squeaks in operation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0699733
UMLS CUI [1,3]
C0028263
Device rattles in operation
Descrição

Device rattles in operation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0699733
UMLS CUI [1,2]
C0028263
Dose counter did not count
Descrição

Dose counter did not count

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0750480
Dose counter is ambiguous
Descrição

Dose counter is ambiguous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0332241
Dose counter overcounted
Descrição

Dose counter overcounted

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0439093
Dose counter undercounted
Descrição

Dose counter undercounted

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0439092
Difficult to pull air through the device as described in the leaflet
Descrição

Difficult to pull air through the device

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332218
UMLS CUI [1,2]
C3536832
UMLS CUI [1,3]
C0699733
Device smelt/bad odour when pack opened
Descrição

Device smelt/bad odour when pack opened

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0699733
UMLS CUI [1,2]
C0037361
Other reasons
Descrição

Other reasons

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3840932
If other reason, please specify
Descrição

Other reason specification

Tipo de dados

text

Alias
UMLS CUI [1]
C3840932
Voltar ao início da página

Similar models

IP Device Malfunction (IPDEVMAL)

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
IP Device Malfunction (IPDEVMAl)
C1881681 (UMLS CUI-1)
lnvestigational product container number
Item
lnvestigational product container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item Group
Reasons for device malfunction
C1881681 (UMLS CUI-1)
C0566251 (UMLS CUI-2)
Mouthpiece Cover, position
Item
Mouthpiece Cover does not stay at the fully actuated position
boolean
C0725867 (UMLS CUI [1,1])
C3888055 (UMLS CUI [1,2])
C1550045 (UMLS CUI [1,3])
Mouthpiece cover detached
Item
Mouthpiece Cover came apart from the mechanism
boolean
C0725867 (UMLS CUI [1,1])
C3888055 (UMLS CUI [1,2])
C0687118 (UMLS CUI [1,3])
Inhaler cracked or broken apart
Item
Inhaler is cracked or broken apart
boolean
C0021461 (UMLS CUI [1,1])
C1706353 (UMLS CUI [1,2])
Difficult to open mouthpiece cover
Item
Difficult to open mouthpiece cover/ force to actuate was too high
boolean
C0725867 (UMLS CUI [1,1])
C3888055 (UMLS CUI [1,2])
C0332218 (UMLS CUI [1,3])
C0175566 (UMLS CUI [1,4])
Difficult to close mouthpiece cover
Item
Difficult to close mouthpiece cover
boolean
C0725867 (UMLS CUI [1,1])
C3888055 (UMLS CUI [1,2])
C0332218 (UMLS CUI [1,3])
C3810854 (UMLS CUI [1,4])
Powder fell lost prior to use
Item
Powder fell lost prior to use
boolean
C0991575 (UMLS CUI [1,1])
C0745777 (UMLS CUI [1,2])
No powder came out (Emission substance)
Item
No powder came out (Emission substance)
boolean
C1298908 (UMLS CUI [1,1])
C0991575 (UMLS CUI [1,2])
C2349995 (UMLS CUI [1,3])
No Device squeaks in operation
Item
No Device squeaks in operation
boolean
C1298908 (UMLS CUI [1,1])
C0699733 (UMLS CUI [1,2])
C0028263 (UMLS CUI [1,3])
Device rattles in operation
Item
Device rattles in operation
boolean
C0699733 (UMLS CUI [1,1])
C0028263 (UMLS CUI [1,2])
Dose counter did not count
Item
Dose counter did not count
boolean
C0178602 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Dose counter is ambiguous
Item
Dose counter is ambiguous
boolean
C0178602 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0332241 (UMLS CUI [1,3])
Dose counter overcounted
Item
Dose counter overcounted
boolean
C0178602 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0439093 (UMLS CUI [1,3])
Dose counter undercounted
Item
Dose counter undercounted
boolean
C0178602 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0439092 (UMLS CUI [1,3])
Difficult to pull air through the device
Item
Difficult to pull air through the device as described in the leaflet
boolean
C0332218 (UMLS CUI [1,1])
C3536832 (UMLS CUI [1,2])
C0699733 (UMLS CUI [1,3])
Device smelt/bad odour when pack opened
Item
Device smelt/bad odour when pack opened
boolean
C0699733 (UMLS CUI [1,1])
C0037361 (UMLS CUI [1,2])
Other reasons
Item
Other reasons
boolean
C3840932 (UMLS CUI [1])
Other reason specification
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial