ID

32495

Beschrijving

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

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Versies (2)
  1. 05-11-18 05-11-18 -
  2. 04-12-18 04-12-18 -
Houder van rechten

GSK group of companies

Geüploaded op

5 november 2018

DOI

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Licentie

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

Engels

Asthma/COPD Exacerbations

1 Formulieren  
Asthma Exacerbations
Beschrijving

Asthma Exacerbations

Date of Onset
Beschrijving

Date of Onset

Datatype

date

Outcome
Beschrijving

Outcome

Datatype

text

End Date
Beschrijving

If FATAL, Date of Death

Datatype

date

Was the subject withdrawn due to this exacerbation?
Beschrijving

Was the subject withdrawn due to this exacerbation?

Datatype

boolean

Were systemic/oral corticosteroids taken for the exacerbation?
Beschrijving

Were systemic/oral corticosteroids taken for the exacerbation?

Datatype

boolean

Was the subject hospitalised due to this exacerbation?
Beschrijving

Was the subject hospitalised due to this exacerbation?

Datatype

boolean

Did the subject visit the emergency room due to this exacerbation?
Beschrijving

Did the subject visit the emergency room due to this exacerbation?

Datatype

boolean

Was the subject intubated for this exacerbation?
Beschrijving

Was the subject intubated for this exacerbation?

Datatype

boolean

Which of the following lead to the diagnosis of a severe asthma exacerbation?
Beschrijving

Which of the following lead to the diagnosis of a severe asthma exacerbation?

Datatype

text

7. Other
Beschrijving

specify

Datatype

text

Contact Method/Treatment Site for Exacerbations
Beschrijving

Contact Method/Treatment Site for Exacerbations

Number of home visits (Day)
Beschrijving

If non, enter 0 (zero)

Datatype

integer

Number of home visits (Night)
Beschrijving

Number of home visits (Night)

Datatype

integer

Number of physician office/practice visits
Beschrijving

If none, enter 0 (zero)

Datatype

integer

Number of urgent care/outpatient clinic visit
Beschrijving

If none, enter 0 (zero)

Datatype

integer

Number of emergency room visits
Beschrijving

If none, enter 0 (zero)

Datatype

integer

Number of inpatient hospitalisation days
Beschrijving

If none, enter 0 (zero)

Datatype

integer

Exacerbation Medications Entry
Beschrijving

Exacerbation Medications Entry

Sequence number
Beschrijving

Sequence number

Datatype

integer

Drug Name
Beschrijving

Trade Name preferred

Datatype

text

Unit Dose
Beschrijving

Unit Dose

Datatype

text

Units
Beschrijving

Units

Datatype

text

Frequency
Beschrijving

Frequency

Datatype

text

Route
Beschrijving

Route

Datatype

text

Start Date
Beschrijving

Start Date

Datatype

date

Taken prior to study?
Beschrijving

Taken prior to study?

Datatype

boolean

Ongoing?
Beschrijving

Ongoing?

Datatype

boolean

if No, record End Date
Beschrijving

if No, record End Date

Datatype

date

Medication Type
Beschrijving

Medication Type

Datatype

text

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Similar models

Asthma/COPD Exacerbations

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Asthma Exacerbations
Date of Onset
Item
Date of Onset
date
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Fatal (2)
CL Item
Not resolved (3)
End Date
Item
End Date
date
Was the subject withdrawn due to this exacerbation?
Item
Was the subject withdrawn due to this exacerbation?
boolean
Were systemic/oral corticosteroids taken for the exacerbation?
Item
Were systemic/oral corticosteroids taken for the exacerbation?
boolean
Was the subject hospitalised due to this exacerbation?
Item
Was the subject hospitalised due to this exacerbation?
boolean
Did the subject visit the emergency room due to this exacerbation?
Item
Did the subject visit the emergency room due to this exacerbation?
boolean
Was the subject intubated for this exacerbation?
Item
Was the subject intubated for this exacerbation?
boolean
Item
Which of the following lead to the diagnosis of a severe asthma exacerbation?
text
Which of the following lead to the diagnosis of a severe asthma exacerbation?
Code List
Which of the following lead to the diagnosis of a severe asthma exacerbation?
CL Item
Worsening daytime symptoms (1)
CL Item
Worsening nighttime symptoms (2)
CL Item
Decreasing peak flow (3)
CL Item
Decreasing FEV1 (4)
CL Item
Increasing rescue medication use (5)
CL Item
Clinical examination (e.g., increased wheezing heard with stethoscope) (6)
7. Other
Item
7. Other
text
Item Group
Contact Method/Treatment Site for Exacerbations
Number of home visits (Day)
Item
Number of home visits (Day)
integer
Number of home visits (Night)
Item
Number of home visits (Night)
integer
Number of physician office/practice visits
Item
Number of physician office/practice visits
integer
Number of urgent care/outpatient clinic visit
Item
Number of urgent care/outpatient clinic visit
integer
Number of emergency room visits
Item
Number of emergency room visits
integer
Number of inpatient hospitalisation days
Item
Number of inpatient hospitalisation days
integer
Item Group
Exacerbation Medications Entry
Sequence number
Item
Sequence number
integer
Drug Name
Item
Drug Name
text
Unit Dose
Item
Unit Dose
text
Item
Units
text
Units
Code List
Units
CL Item
Capsule (CAP) (1)
CL Item
Gram (G) (2)
CL Item
Litre (L) (3)
CL Item
Microgram (MCG) (4)
CL Item
Microlitre (MGL) (5)
CL Item
Miligram (MG) (6)
CL Item
Mililite (ML) (7)
CL Item
Tablet (TAB) (8)
CL Item
Unknown (UNK) (9)
Frequency
Item
Frequency
text
Item
Route
text
Route
Code List
Route
CL Item
Inhalation (1)
CL Item
Intramuscular (2)
CL Item
Intranasal (3)
CL Item
Injection (4)
CL Item
Intravenous (5)
CL Item
Nasal (6)
CL Item
Other (7)
CL Item
Oral (8)
CL Item
Subcutaneous (9)
Start Date
Item
Start Date
date
Taken prior to study?
Item
Taken prior to study?
boolean
Ongoing?
Item
Ongoing?
boolean
if No, record End Date
Item
if No, record End Date
date
Item
Medication Type
text
Medication Type
Code List
Medication Type
CL Item
Asthma Med (1)
CL Item
COPD Med (2)
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