ID

24594

Description

Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

Keywords

Versions (3)
  1. 7/27/17 7/27/17 -
  2. 7/27/17 7/27/17 -
  3. 8/8/17 8/8/17 -
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August 8, 2017

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Creative Commons BY-NC 3.0
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visit 2 (randomisation) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

English

visit 2 (randomisation) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

subject identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
CURRENT TOBACCO USE
Description

CURRENT TOBACCO USE

Alias
UMLS CUI-1
C0543414
Has the subject smoked/used tobacco since the last visit?
Description

use of tobacco since last visit

Data type

text

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1517741
BASELINE DYSPNOEA INDEX (BDI)
Description

BASELINE DYSPNOEA INDEX (BDI)

Alias
UMLS CUI-1
C1511069
OROPHARYNGEAL CANDIDIASIS EXAMINATION
Description

OROPHARYNGEAL CANDIDIASIS EXAMINATION

Alias
UMLS CUI-1
C0006849
UMLS CUI-2
C0582103
Does the subject have clinical evidence of oropharyngeal candidiasis?
Description

clinical evidence of oropharyngeal candidiasis

Data type

text

Alias
UMLS CUI [1,1]
C0006849
UMLS CUI [1,2]
C3887511
Was a swab taken?
Description

Swab need only be taken if there is clinical evidence of oropharyngeal candidiasis

Data type

text

Alias
UMLS CUI [1,1]
C0006849
UMLS CUI [1,2]
C0563454
if a swab was taken, result of the swab?
Description

oropharyngeal candidiasis test result

Data type

integer

Alias
UMLS CUI [1,1]
C0006849
UMLS CUI [1,2]
C0563454
UMLS CUI [1,3]
C1274040
VITAL SIGNS
Description

VITAL SIGNS

Alias
UMLS CUI-1
C0518766
Blood pressure
Description

Position: sitting.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Description

heart rate

Data type

integer

Measurement units
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute
PULMONARY FUNCTION TESTING
Description

PULMONARY FUNCTION TESTING

Alias
UMLS CUI-1
C0024119
Has the subject taken VENTOLIN in the last 6 hours?
Description

ventolin taken in the last hours

Data type

text

Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C1632850
pulmonary funtion testing: FEV1
Description

pulmonary funtion testing: FEV1

Alias
UMLS CUI-1
C0748133
Time of Assessment PreVENTOLIN
Description

time of assessment before Ventolin

Data type

time

Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0220825
Actual Measurement PreVENTOLIN
Description

Actual Measurement PreVENTOLIN = A

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C0242485
L
pulmonary function testing: FVC
Description

pulmonary function testing: FVC

Alias
UMLS CUI-1
C3714541
Actual Measurement PreVENTOLIN
Description

Actual Measurement PreVENTOLIN = A

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C0242485
L
pulmonary function testing: FEV1 /FVC ratio
Description

pulmonary function testing: FEV1 /FVC ratio

Alias
UMLS CUI-1
C0429745
Actual Measurement PreVENTOLIN
Description

Actual Measurement PreVENTOLIN = A

Data type

float

Measurement units
  • L
Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C0242485
L
ST. GEORGE’S RESPIRATORY QUESTIONNAIRE
Description

ST. GEORGE’S RESPIRATORY QUESTIONNAIRE

Alias
UMLS CUI-1
C0451500
Confirm the SGRQ has been completed by the subject
Description

SGRQ completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0451500
UMLS CUI [1,2]
C0205197
EQ-5D (Euroqol)
Description

EQ-5D (Euroqol)

Alias
UMLS CUI-1
C2733251
Confirm the EQ-5D has been completed by the subject.
Description

EQ-5D completed

Data type

boolean

Alias
UMLS CUI [1,1]
C2733251
UMLS CUI [1,2]
C0205197
RANDOMISATION NUMBER
Description

RANDOMISATION NUMBER

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Record randomisation number.
Description

randomisation number

Data type

float

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
INVESTIGATIONAL PRODUCT CONTAINER NUMBER
Description

INVESTIGATIONAL PRODUCT CONTAINER NUMBER

Alias
UMLS CUI-1
C3898691
UMLS CUI-2
C0449788
Record the identifying number from the investigational product container dispensed at this visit.
Description

investigational product containernumber

Data type

integer

Alias
UMLS CUI [1,1]
C3898691
UMLS CUI [1,2]
C0449788
TRANSITION DYSPNOEA INDEX (TDI)
Description

TRANSITION DYSPNOEA INDEX (TDI)

Alias
UMLS CUI-1
C3714807
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Similar models

visit 2 (randomisation) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
CURRENT TOBACCO USE
C0543414 (UMLS CUI-1)
Item
Has the subject smoked/used tobacco since the last visit?
text
C0543414 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
use of tobacco since last visit
Code List
Has the subject smoked/used tobacco since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
BASELINE DYSPNOEA INDEX (BDI)
C1511069 (UMLS CUI-1)
Item Group
OROPHARYNGEAL CANDIDIASIS EXAMINATION
C0006849 (UMLS CUI-1)
C0582103 (UMLS CUI-2)
Item
Does the subject have clinical evidence of oropharyngeal candidiasis?
text
C0006849 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
clinical evidence of oropharyngeal candidiasis
Code List
Does the subject have clinical evidence of oropharyngeal candidiasis?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was a swab taken?
text
C0006849 (UMLS CUI [1,1])
C0563454 (UMLS CUI [1,2])
taking of a swab
Code List
Was a swab taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
if a swab was taken, result of the swab?
integer
C0006849 (UMLS CUI [1,1])
C0563454 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
oropharyngeal candidiasis test result
Code List
if a swab was taken, result of the swab?
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not available (4)
Item Group
VITAL SIGNS
C0518766 (UMLS CUI-1)
blood pressure
Item
Blood pressure
integer
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
PULMONARY FUNCTION TESTING
C0024119 (UMLS CUI-1)
Item
Has the subject taken VENTOLIN in the last 6 hours?
text
C0033744 (UMLS CUI [1,1])
C1632850 (UMLS CUI [1,2])
use of bronchodilatators before lung function measurement
Code List
Has the subject taken VENTOLIN in the last 6 hours?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
pulmonary funtion testing: FEV1
C0748133 (UMLS CUI-1)
time of assessment before Ventolin
Item
Time of Assessment PreVENTOLIN
time
C0033744 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
measurement before Ventolin
Item
Actual Measurement PreVENTOLIN
float
C0033744 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Item Group
pulmonary function testing: FVC
C3714541 (UMLS CUI-1)
measurement before Ventolin
Item
Actual Measurement PreVENTOLIN
float
C0033744 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Item Group
pulmonary function testing: FEV1 /FVC ratio
C0429745 (UMLS CUI-1)
measurement before Ventolin
Item
Actual Measurement PreVENTOLIN
float
C0033744 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Item Group
ST. GEORGE’S RESPIRATORY QUESTIONNAIRE
C0451500 (UMLS CUI-1)
SGRQ completed
Item
Confirm the SGRQ has been completed by the subject
boolean
C0451500 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item Group
EQ-5D (Euroqol)
C2733251 (UMLS CUI-1)
EQ-5D completed
Item
Confirm the EQ-5D has been completed by the subject.
boolean
C2733251 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item Group
RANDOMISATION NUMBER
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
randomisation number
Item
Record randomisation number.
float
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
INVESTIGATIONAL PRODUCT CONTAINER NUMBER
C3898691 (UMLS CUI-1)
C0449788 (UMLS CUI-2)
investigational product containernumber
Item
Record the identifying number from the investigational product container dispensed at this visit.
integer
C3898691 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
TRANSITION DYSPNOEA INDEX (TDI)
C3714807 (UMLS CUI-1)
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