ID

24228

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2017-07-27 2017-07-27 -
  2. 2017-08-08 2017-08-08 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

27 juli 2017

DOI

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Creative Commons BY-NC 3.0 Legacy
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visit 5 (treatment period) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

Engelsk

visit 5 (treatment period) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 Formulär  
CURRENT TOBACCO USE
Beskrivning

CURRENT TOBACCO USE

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

use of tobacco since last visit

Datatyp

text

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1517741
TRANSITION DYSPNOEA INDEX (TDI)
Beskrivning

TRANSITION DYSPNOEA INDEX (TDI)

Alias
UMLS CUI-1
C3714807
OROPHARYNGEAL CANDIDIASIS EXAMINATION
Beskrivning

OROPHARYNGEAL CANDIDIASIS EXAMINATION

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

clinical evidence of oropharyngeal candidiasis

Datatyp

text

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

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

Datatyp

text

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

oropharyngeal candidiasis test result

Datatyp

integer

Alias
UMLS CUI [1,1]
C0006849
UMLS CUI [1,2]
C0563454
UMLS CUI [1,3]
C1274040
PULMONARY FUNCTION TESTING
Beskrivning

PULMONARY FUNCTION TESTING

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

ventolin taken in the last hours

Datatyp

text

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

pulmonary funtion testing: FEV1

Alias
UMLS CUI-1
C0748133
Time of Assessment Pre-dose
Beskrivning

time of pre-dose measurement

Datatyp

time

Alias
UMLS CUI [1,1]
C3812758
UMLS CUI [1,2]
C0040223
Actual Measurement Pre-dose
Beskrivning

Best test

Datatyp

float

Måttenheter
  • L
Alias
UMLS CUI [1]
C3812758
L
Time of Assessment Post-dose
Beskrivning

time of post-dose measurement

Datatyp

time

Alias
UMLS CUI [1,1]
C0439568
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C0040223
Actual Measurement 2 hours Post-dose
Beskrivning

Best test

Datatyp

float

Måttenheter
  • L
Alias
UMLS CUI [1,1]
C0439572
UMLS CUI [1,2]
C0242485
L
pulmonary function testing: FVC
Beskrivning

pulmonary function testing: FVC

Alias
UMLS CUI-1
C3714541
Actual Measurement Pre-dose
Beskrivning

Best test

Datatyp

float

Måttenheter
  • L
Alias
UMLS CUI [1]
C3812758
L
Actual Measurement 2 hours Post-dose
Beskrivning

Best test

Datatyp

float

Måttenheter
  • L
Alias
UMLS CUI [1,1]
C0439572
UMLS CUI [1,2]
C0242485
L
pulmonary function testing: FEV1 /FVC ratio
Beskrivning

pulmonary function testing: FEV1 /FVC ratio

Alias
UMLS CUI-1
C0429745
Actual Measurement Pre-dose
Beskrivning

Best test

Datatyp

float

Måttenheter
  • L
Alias
UMLS CUI [1]
C3812758
L
Actual Measurement 2 hours Post-dose
Beskrivning

Best test

Datatyp

float

Måttenheter
  • L
Alias
UMLS CUI [1,1]
C0439572
UMLS CUI [1,2]
C0242485
L
ST. GEORGE’S RESPIRATORY QUESTIONNAIRE
Beskrivning

ST. GEORGE’S RESPIRATORY QUESTIONNAIRE

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

SGRQ completed

Datatyp

boolean

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

EQ-5D (Euroqol)

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

EQ-5D completed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2733251
UMLS CUI [1,2]
C0205197
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Similar models

visit 5 (treatment period) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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
TRANSITION DYSPNOEA INDEX (TDI)
C3714807 (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 of oropharyngeal candididasis
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
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 pre-dose measurement
Item
Time of Assessment Pre-dose
time
C3812758 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
pre-dose measurement
Item
Actual Measurement Pre-dose
float
C3812758 (UMLS CUI [1])
time of post-dose measurement
Item
Time of Assessment Post-dose
time
C0439568 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
2 hours post-dose measurement
Item
Actual Measurement 2 hours Post-dose
float
C0439572 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Item Group
pulmonary function testing: FVC
C3714541 (UMLS CUI-1)
pre-dose measurement
Item
Actual Measurement Pre-dose
float
C3812758 (UMLS CUI [1])
2 hours post-dose measurement
Item
Actual Measurement 2 hours Post-dose
float
C0439572 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Item Group
pulmonary function testing: FEV1 /FVC ratio
C0429745 (UMLS CUI-1)
pre-dose measurement
Item
Actual Measurement Pre-dose
float
C3812758 (UMLS CUI [1])
2 hours post-dose measurement
Item
Actual Measurement 2 hours Post-dose
float
C0439572 (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])
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