ID

33294

Descrição

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

Palavras-chave

Versões (2)
  1. 05/11/2018 05/11/2018 -
  2. 04/12/2018 04/12/2018 -
Titular dos direitos

GSK group of companies

Transferido a

4 de dezembro de 2018

DOI

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Licença

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

Inglês

Asthma/COPD Exacerbations

1 Formulários  
Asthma Exacerbations
Descrição

Asthma Exacerbations

Alias
UMLS CUI-1
C0349790
Date of Onset
Descrição

Date of Onset

Tipo de dados

date

Alias
UMLS CUI [1]
C0574845
Asthma Exacerbation Outcome
Descrição

Outcome

Tipo de dados

text

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

If FATAL, Date of Death

Tipo de dados

date

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Was the subject withdrawn due to this exacerbation?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

Was the subject withdrawn due to this exacerbation?

Tipo de dados

boolean

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

Were systemic/oral corticosteroids taken for the exacerbation?

Tipo de dados

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?
Descrição

Was the subject hospitalised due to this exacerbation?

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

Was the subject intubated for this exacerbation?

Tipo de dados

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?
Descrição

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

Tipo de dados

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.
Descrição

specify

Tipo de dados

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
Descrição

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)
Descrição

If non, enter 0 (zero)

Tipo de dados

integer

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

Number of home visits (Night)

Tipo de dados

integer

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

If none, enter 0 (zero)

Tipo de dados

integer

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

If none, enter 0 (zero)

Tipo de dados

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
Descrição

If none, enter 0 (zero)

Tipo de dados

integer

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

If none, enter 0 (zero)

Tipo de dados

integer

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

Exacerbation Medications Entry

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

Sequence number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348184
Drug Name
Descrição

Trade Name preferred

Tipo de dados

text

Alias
UMLS CUI [1]
C2360065
Unit Dose
Descrição

Unit Dose

Tipo de dados

text

Alias
UMLS CUI [1]
C0869039
Units
Descrição

Units

Tipo de dados

text

Alias
UMLS CUI [1]
C1519795
Frequency
Descrição

Frequency

Tipo de dados

text

Alias
UMLS CUI [1]
C3476109
Medication Route
Descrição

Route

Tipo de dados

text

Alias
UMLS CUI [1]
C0013153
Start Date
Descrição

Start Date

Tipo de dados

date

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

Taken prior to study?

Tipo de dados

boolean

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

Ongoing?

Tipo de dados

boolean

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

if No, record End Date

Tipo de dados

date

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

Medication Type

Tipo de dados

text

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

Asthma/COPD Exacerbations

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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