ID

32504

Description

Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Keywords

Versions (2)
  1. 5/11/18 5/11/18 -
  2. 6/12/18 6/12/18 -
Copyright Holder

GSK group of companies

Uploaded on

5 de noviembre de 2018

DOI

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License

Creative Commons BY-NC 3.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

English

IP Device Malfunction Data

1 forms  
IP Device Malfunction
Description

IP Device Malfunction

Investigation Product Container Number
Description

Complete a new form for each device that malfunctioned during the study

Data type

text

Mark all applicable reasons for this device
Description

Mark all applicable reasons for this device

Mouthpiece cover does not stay at the fully actuated position
Description

Mouthpiece cover does not stay at the fully actuated position

Data type

boolean

Mouthpiece cover came apart from the mechanism
Description

Mouthpiece cover came apart from the mechanism

Data type

boolean

Inhaler is cracked or broken apart
Description

Inhaler is cracked or broken apart

Data type

boolean

Difficult to open mouthpiece cover/force to actuate was too high
Description

Difficult to open mouthpiece cover/force to actuate was too high

Data type

boolean

Difficult to close mouthpiece cover
Description

Difficult to close mouthpiece cover

Data type

boolean

Powder fell out prior to use
Description

Powder fell out prior to use

Data type

boolean

No powder came out
Description

No powder came out

Data type

boolean

Device squeaks in operation
Description

Device squeaks in operation

Data type

boolean

Device rattles in operation
Description

Device rattles in operation

Data type

boolean

Dose counter did not count
Description

Dose counter did not count

Data type

boolean

Dose counter is ambiguous
Description

Dose counter is ambiguous

Data type

boolean

Dose counter overcounted
Description

Dose counter overcounted

Data type

boolean

Dose counter undercounted
Description

Dose counter undercounted

Data type

boolean

Difficult to pull air through the device as described in the leaflet
Description

Difficult to pull air through the device as described in the leaflet

Data type

boolean

Device smelt/bad odour when pack opened
Description

Device smelt/bad odour when pack opened

Data type

boolean

Other, specify
Description

Other, specify

Data type

text

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Similar models

IP Device Malfunction Data

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
IP Device Malfunction
Investigation Product Container Number
Item
Investigation Product Container Number
text
Item Group
Mark all applicable reasons for this device
Mouthpiece cover does not stay at the fully actuated position
Item
Mouthpiece cover does not stay at the fully actuated position
boolean
Mouthpiece cover came apart from the mechanism
Item
Mouthpiece cover came apart from the mechanism
boolean
Inhaler is cracked or broken apart
Item
Inhaler is cracked or broken apart
boolean
Difficult to open mouthpiece cover/force to actuate was too high
Item
Difficult to open mouthpiece cover/force to actuate was too high
boolean
Difficult to close mouthpiece cover
Item
Difficult to close mouthpiece cover
boolean
Powder fell out prior to use
Item
Powder fell out prior to use
boolean
No powder came out
Item
No powder came out
boolean
Device squeaks in operation
Item
Device squeaks in operation
boolean
Device rattles in operation
Item
Device rattles in operation
boolean
Dose counter did not count
Item
Dose counter did not count
boolean
Dose counter is ambiguous
Item
Dose counter is ambiguous
boolean
Dose counter overcounted
Item
Dose counter overcounted
boolean
Dose counter undercounted
Item
Dose counter undercounted
boolean
Difficult to pull air through the device as described in the leaflet
Item
Difficult to pull air through the device as described in the leaflet
boolean
Device smelt/bad odour when pack opened
Item
Device smelt/bad odour when pack opened
boolean
Other, specify
Item
Other, specify
text
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