ID

24602

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

Mots-clés

Versions (2)
  1. 05/08/2017 05/08/2017 -
  2. 08/08/2017 08/08/2017 -
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8 août 2017

DOI

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Licence

Creative Commons BY-NC 3.0
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withdrawal salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

Anglais

withdrawal salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 Formulaires  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

subject identifier

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

date of visit

Type de données

date

Alias
UMLS CUI [1]
C1320303
CURRENT TOBACCO USE
Description

CURRENT TOBACCO USE

Alias
UMLS CUI-1
C0543414
UMLS CUI-2
C0521116
Has the subject smoked/used tobacco since the last visit?
Description

use of tobacco since last visit

Type de données

text

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1517741
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

Type de données

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

Type de données

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

Type de données

integer

Alias
UMLS CUI [1,1]
C0006849
UMLS CUI [1,2]
C0563454
UMLS CUI [1,3]
C1274040
FAT FREE MASS
Description

FAT FREE MASS

Alias
UMLS CUI-1
C0424679
Serial number
Description

serial number

Type de données

integer

Alias
UMLS CUI [1]
C2348188
Test number
Description

testing number

Type de données

integer

Alias
UMLS CUI [1,1]
C0039593
UMLS CUI [1,2]
C0237753
Subject’s height at time of measurement
Description

height

Type de données

integer

Unités de mesure
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Subject’s weight at time of measurement
Description

weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Fat Free Mass (Lean Muscle Mass including Muscle, Water, and Bone)
Description

fat free mass

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0424679
kg
Impedance (The resistance)
Description

impedance

Type de données

integer

Unités de mesure
  • ohm
Alias
UMLS CUI [1]
C0162537
ohm
CENTRAL LABORATORY - BLOOD
Description

CENTRAL LABORATORY - BLOOD

Alias
UMLS CUI-1
C0018941
Date sample taken
Description

blood sample taken

Type de données

date

Alias
UMLS CUI [1]
C1277698
VITAL SIGNS
Description

VITAL SIGNS

Alias
UMLS CUI-1
C0518766
Blood pressure
Description

Position: sitting

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Description

heart rate

Type de données

integer

Unités de mesure
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
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

Type de données

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 Pre-dose
Description

time of pre-dose measurement

Type de données

time

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

Best test

Type de données

float

Unités de mesure
  • L
Alias
UMLS CUI [1]
C3812758
L
Time of Assessment Post-dose
Description

time of post-dose measurement

Type de données

time

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

Best test

Type de données

float

Unités de mesure
  • L
Alias
UMLS CUI [1,1]
C0439572
UMLS CUI [1,2]
C0242485
L
pulmonary function testing: FVC
Description

pulmonary function testing: FVC

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

Best test

Type de données

float

Unités de mesure
  • L
Alias
UMLS CUI [1]
C3812758
L
Actual Measurement 2 hours Post-dose
Description

Best test

Type de données

float

Unités de mesure
  • L
Alias
UMLS CUI [1,1]
C0439572
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 Pre-dose
Description

Best test

Type de données

float

Unités de mesure
  • L
Alias
UMLS CUI [1]
C3812758
L
Actual Measurement 2 hours Post-dose
Description

Best test

Type de données

float

Unités de mesure
  • L
Alias
UMLS CUI [1,1]
C0439572
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

St George's hospital respiratory questionnaire

Type de données

boolean

Alias
UMLS CUI [1]
C0451500
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

Type de données

boolean

Alias
UMLS CUI [1]
C2733251
SUBJECT AND PHYSICIAN GLOBAL IMPRESSION
Description

SUBJECT AND PHYSICIAN GLOBAL IMPRESSION

Alias
UMLS CUI-1
C0596764
UMLS CUI-2
C0681850
UMLS CUI-4
C0596764
UMLS CUI-5
C0031831
Subject Question: How do you feel now in comparison with when you started to take study medication?
Description

assessment of study medication

Type de données

integer

Alias
UMLS CUI [1,1]
C2826299
UMLS CUI [1,2]
C1516048
Physician Question: How do you assess the patient’s COPD now in comparison to when they started to take study medication?
Description

COPD assessment after study medication

Type de données

integer

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C2826299
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Similar models

withdrawal salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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)
C0521116 (UMLS CUI-2)
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
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
FAT FREE MASS
C0424679 (UMLS CUI-1)
serial number
Item
Serial number
integer
C2348188 (UMLS CUI [1])
testing number
Item
Test number
integer
C0039593 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
height
Item
Subject’s height at time of measurement
integer
C0005890 (UMLS CUI [1])
weight
Item
Subject’s weight at time of measurement
float
C0005910 (UMLS CUI [1])
fat free mass
Item
Fat Free Mass (Lean Muscle Mass including Muscle, Water, and Bone)
float
C0424679 (UMLS CUI [1])
impedance
Item
Impedance (The resistance)
integer
C0162537 (UMLS CUI [1])
Item Group
CENTRAL LABORATORY - BLOOD
C0018941 (UMLS CUI-1)
blood sample taken
Item
Date sample taken
date
C1277698 (UMLS CUI [1])
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 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)
St George's hospital respiratory questionnaire
Item
Confirm the SGRQ has been completed by the subject
boolean
C0451500 (UMLS CUI [1])
Item Group
EQ-5D (Euroqol)
C2733251 (UMLS CUI-1)
EQ-5D
Item
Confirm the EQ-5D has been completed by the subject.
boolean
C2733251 (UMLS CUI [1])
Item Group
SUBJECT AND PHYSICIAN GLOBAL IMPRESSION
C0596764 (UMLS CUI-1)
C0681850 (UMLS CUI-2)
C0596764 (UMLS CUI-4)
C0031831 (UMLS CUI-5)
Item
Subject Question: How do you feel now in comparison with when you started to take study medication?
integer
C2826299 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
assessment of study medication
Code List
Subject Question: How do you feel now in comparison with when you started to take study medication?
CL Item
Not assessed (0)
CL Item
Very much improved (1)
CL Item
Much improved (2)
CL Item
Minimally improved (3)
CL Item
No change (4)
CL Item
Minimally worse (5)
CL Item
Much worse (6)
CL Item
Very much worse (7)
Item
Physician Question: How do you assess the patient’s COPD now in comparison to when they started to take study medication?
integer
C0024117 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C2826299 (UMLS CUI [1,3])
COPD assessment after study medication
Code List
Physician Question: How do you assess the patient’s COPD now in comparison to when they started to take study medication?
CL Item
Not assessed (0)
CL Item
Very much improved (1)
CL Item
Much improved (2)
CL Item
Minimally improved (3)
CL Item
No change (4)
CL Item
Minimally worse (5)
CL Item
Much worse (6)
CL Item
Very much worse (7)
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