ID

33294

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. 11/5/18 11/5/18 -
  2. 12/4/18 12/4/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 4, 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

Asthma/COPD Exacerbations

1 forms  
Asthma Exacerbations
Description

Asthma Exacerbations

Alias
UMLS CUI-1
C0349790
Date of Onset
Description

Date of Onset

Data type

date

Alias
UMLS CUI [1]
C0574845
Asthma Exacerbation Outcome
Description

Outcome

Data type

text

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C1547647
End Date if Outcome is "resolved" or "fatal"
Description

If FATAL, Date of Death

Data type

date

Alias
UMLS CUI [1,1]
C1547647
UMLS CUI [1,2]
C0806020
Was the subject withdrawn due to this exacerbation?
Description

Was the subject withdrawn due to this exacerbation?

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0349790
Were systemic/oral corticosteroids taken for the exacerbation?
Description

Were systemic/oral corticosteroids taken for the exacerbation?

Data type

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C0574135
UMLS CUI [1,3]
C0349790
Was the subject hospitalised due to this exacerbation?
Description

Was the subject hospitalised due to this exacerbation?

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0349790
Did the subject visit the emergency room due to this exacerbation?
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0583237
UMLS CUI [1,2]
C0349790
Was the subject intubated for this exacerbation?
Description

Was the subject intubated for this exacerbation?

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0021925
Which of the following lead to the diagnosis of a severe asthma exacerbation?
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0011900
If other reason lead to the diagnosis of a severe asthma exacerbation, specify.
Description

specify

Data type

text

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Contact Method/Treatment Site for Exacerbations
Description

Contact Method/Treatment Site for Exacerbations

Alias
UMLS CUI-1
C0332158
UMLS CUI-2
C0025663
UMLS CUI-3
C0337950
UMLS CUI-4
C0349790
Number of home visits (Day)
Description

If non, enter 0 (zero)

Data type

integer

Alias
UMLS CUI [1,1]
C0020043
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0439228
Number of home visits (Night)
Description

Number of home visits (Night)

Data type

integer

Alias
UMLS CUI [1,1]
C0020043
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0240526
Number of physician office/practice visits
Description

If none, enter 0 (zero)

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0031834
UMLS CUI [1,3]
C0449788
Number of urgent care/outpatient clinic visit
Description

If none, enter 0 (zero)

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1551285
UMLS CUI [1,3]
C0008952
UMLS CUI [1,4]
C0029921
Number of emergency room visits
Description

If none, enter 0 (zero)

Data type

integer

Alias
UMLS CUI [1,1]
C2114437
UMLS CUI [1,2]
C0449788
Number of inpatient hospitalisation days
Description

If none, enter 0 (zero)

Data type

integer

Alias
UMLS CUI [1,1]
C0420496
UMLS CUI [1,2]
C0019993
Exacerbation Medications Entry
Description

Exacerbation Medications Entry

Alias
UMLS CUI-1
C0349790
UMLS CUI-2
C0013227
Sequence number
Description

Sequence number

Data type

integer

Alias
UMLS CUI [1]
C2348184
Drug Name
Description

Trade Name preferred

Data type

text

Alias
UMLS CUI [1]
C2360065
Unit Dose
Description

Unit Dose

Data type

text

Alias
UMLS CUI [1]
C0869039
Units
Description

Units

Data type

text

Alias
UMLS CUI [1]
C1519795
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Taken prior to study?
Description

Taken prior to study?

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C0332152
Medication Ongoing?
Description

Ongoing?

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
if No, record End Date
Description

if No, record End Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication Type
Description

Medication Type

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332307
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Similar models

Asthma/COPD Exacerbations

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Asthma Exacerbations
C0349790 (UMLS CUI-1)
Date of Onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1])
Item
Asthma Exacerbation Outcome
text
C0349790 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
Outcome
Code List
Asthma Exacerbation Outcome
CL Item
Resolved (1)
CL Item
Fatal (2)
CL Item
Not resolved (3)
End Date
Item
End Date if Outcome is "resolved" or "fatal"
date
C1547647 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Was the subject withdrawn due to this exacerbation?
Item
Was the subject withdrawn due to this exacerbation?
boolean
C0422727 (UMLS CUI [1,1])
C0349790 (UMLS CUI [1,2])
Were systemic/oral corticosteroids taken for the exacerbation?
Item
Were systemic/oral corticosteroids taken for the exacerbation?
boolean
C2825233 (UMLS CUI [1,1])
C0574135 (UMLS CUI [1,2])
C0349790 (UMLS CUI [1,3])
Was the subject hospitalised due to this exacerbation?
Item
Was the subject hospitalised due to this exacerbation?
boolean
C0019993 (UMLS CUI [1,1])
C0349790 (UMLS CUI [1,2])
Did the subject visit the emergency room due to this exacerbation?
Item
Did the subject visit the emergency room due to this exacerbation?
boolean
C0583237 (UMLS CUI [1,1])
C0349790 (UMLS CUI [1,2])
Was the subject intubated for this exacerbation?
Item
Was the subject intubated for this exacerbation?
boolean
C0349790 (UMLS CUI [1,1])
C0021925 (UMLS CUI [1,2])
Item
Which of the following lead to the diagnosis of a severe asthma exacerbation?
text
C0349790 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
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)
Other
Item
If other reason lead to the diagnosis of a severe asthma exacerbation, specify.
text
C0349790 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Contact Method/Treatment Site for Exacerbations
C0332158 (UMLS CUI-1)
C0025663 (UMLS CUI-2)
C0337950 (UMLS CUI-3)
C0349790 (UMLS CUI-4)
Number of home visits (Day)
Item
Number of home visits (Day)
integer
C0020043 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Number of home visits (Night)
Item
Number of home visits (Night)
integer
C0020043 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0240526 (UMLS CUI [1,3])
Number of physician office/practice visits
Item
Number of physician office/practice visits
integer
C0545082 (UMLS CUI [1,1])
C0031834 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of urgent care/outpatient clinic visit
Item
Number of urgent care/outpatient clinic visit
integer
C0449788 (UMLS CUI [1,1])
C1551285 (UMLS CUI [1,2])
C0008952 (UMLS CUI [1,3])
C0029921 (UMLS CUI [1,4])
Number of emergency room visits
Item
Number of emergency room visits
integer
C2114437 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of inpatient hospitalisation days
Item
Number of inpatient hospitalisation days
integer
C0420496 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Item Group
Exacerbation Medications Entry
C0349790 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Sequence number
Item
Sequence number
integer
C2348184 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Unit Dose
Item
Unit Dose
text
C0869039 (UMLS CUI [1])
Item
Units
text
C1519795 (UMLS CUI [1])
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
C3476109 (UMLS CUI [1])
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Route
Code List
Medication 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
C0808070 (UMLS CUI [1])
Taken prior to study?
Item
Taken prior to study?
boolean
C0013227 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Ongoing?
Item
Medication Ongoing?
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
if No, record End Date
Item
if No, record End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Medication Type
text
C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Medication Type
Code List
Medication Type
CL Item
Asthma Med (1)
CL Item
COPD Med (2)
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