ID

33998

Description

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

Keywords

Versions (2)
  1. 1/9/19 1/9/19 -
  2. 1/10/19 1/10/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

January 10, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

English

IP Device Malfunction (IPDEVMAL)

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

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

IP Device Malfunction (IPDEVMAl)

Alias
UMLS CUI-1
C1881681
lnvestigational product container number
Description

lnvestigational product container number

Data type

integer

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

Reasons for device malfunction

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

Mouthpiece Cover, position

Data type

boolean

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

Mouthpiece cover detached

Data type

boolean

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

Inhaler cracked or broken apart

Data type

boolean

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

Difficult to open mouthpiece cover

Data type

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
Description

Difficult to close mouthpiece cover

Data type

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
Description

Powder fell lost prior to use

Data type

boolean

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

No powder came out (Emission substance)

Data type

boolean

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

No Device squeaks in operation

Data type

boolean

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

Device rattles in operation

Data type

boolean

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

Dose counter did not count

Data type

boolean

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

Dose counter is ambiguous

Data type

boolean

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

Dose counter overcounted

Data type

boolean

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

Dose counter undercounted

Data type

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
Description

Difficult to pull air through the device

Data type

boolean

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

Device smelt/bad odour when pack opened

Data type

boolean

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

Other reasons

Data type

boolean

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

Other reason specification

Data type

text

Alias
UMLS CUI [1]
C3840932
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Similar models

IP Device Malfunction (IPDEVMAL)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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