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Fel:
ID
24183
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 (4)
- 2017-07-27 2017-07-27 -
- 2017-07-27 2017-07-27 -
- 2017-07-27 2017-07-27 -
- 2017-08-08 2017-08-08 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
27 juli 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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visit 1 (medical evaluation) - effect of salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470
visit 1 (medical evaluation) - effect of salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470
Similar models
visit 1 (medical evaluation) - effect of salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Female (F)
CL Item
Male (M)
CL Item
Arabic/North African (2)
(Comment:en)
CL Item
Black (3)
(Comment:en)
CL Item
East & South East Asian (4)
(Comment:en)
CL Item
other (z)
(Comment:en)
CL Item
South Asian (6)
(Comment:en)
CL Item
White/Caucasian (7)
(Comment:en)
CL Item
Blood and lymphatic system disorders (1)
CL Item
Cardiac disorders (2)
CL Item
Ear and labyrinth disorders (3)
CL Item
Endocrine disorders (4)
CL Item
Eye disorders (5)
CL Item
Gastrointestinal disorders (6)
CL Item
Hepatobiliary disorders (7)
CL Item
Immune system disorders (8)
CL Item
Metabolism and nutrition disorders (9)
CL Item
Musculoskeletal and connective tissue disorders (10)
CL Item
Neoplasms benign, malignant and unspecified (including cysts and polyps) (11)
CL Item
Nervous system disorders (12)
CL Item
Psychiatric disorders (13)
CL Item
Renal and urinary disorders (14)
CL Item
Reproductive system and breast disorders (15)
CL Item
Respiratory, thoracic and mediastinal disorders (16)
CL Item
Skin and subcutaneous tissue disorders (17)
CL Item
Vascular disorders (18)
CL Item
Infections and infestations (19)
CL Item
Congenital, familial and genetic disorders (20)
current medical condition
Item
Current medical condition
boolean
C0521116 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
medical condition
Item
no medical condition
boolean
C0012634 (UMLS CUI [1])
CL Item
current smoker (2)
(Comment:en)
CL Item
former smoker (3)
(Comment:en)
last smoke
Item
if former smoker, when did the subjet last smoke?
date
C0543414 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
cigarettes per day
Item
Average number of cigarettes smoked per day
integer
C3694146 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,2])
number of years smoking
Item
Number of years during which the subject has smoked?
integer
C0037369 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
number of pack years
Item
number of pack years?
integer
C1277691 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
CL Item
< 5 years (9)
CL Item
≥ 5 years to < 10 years (11)
CL Item
≥ 10 years to < 15 years (13)
CL Item
≥ 15 years to < 20 years (15)
CL Item
≥ 20 years to < 25 years (17)
CL Item
≥ 25 years (18)
number of exacerbations managed without drugs
Item
Number of exacerbations in the last 12 months that were managed without oral corticosteroids and/or antibiotics (not involving hospitalisation)
integer
C0740304 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
number of exacerbations requiring drugs
Item
Number of exacerbations in the last 12 months that required oral corticosteroids and/or antibiotics (not involving hospitalisation)
integer
C0740304 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
number of exacerbations requiring hospitalisation
Item
Number of exacerbations in the last 12 months that required hopitalisation
integer
C0740304 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,2])
Item Group
OROPHARYNGEAL CANDIDIASIS EXAMINATION
C0006849 (UMLS CUI-1)
C0582103 (UMLS CUI-2)
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])
C3887511 (UMLS CUI [1,2])
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])
C0563454 (UMLS CUI [1,2])
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])
C0563454 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not available (4)
Item
Has the subject had a chest X-ray within the last 3 months?
text
C0039985 (UMLS CUI [1,1])
C4086725 (UMLS CUI [1,2])
C4086725 (UMLS CUI [1,2])
Code List
Has the subject had a chest X-ray within the last 3 months?
CL Item
Yes (Y)
CL Item
No (N)
date of chest x-ray
Item
if the patient had a chest x-ray in the last 3 months, record the date
date
C0039985 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
date of chest x-ray
Item
if the patient had no chest x-ray in the last 3 months, perform one and record the date
date
C0039985 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Are there any chest abnormalities other than features of COPD?
text
C0497258 (UMLS CUI [1])
CL Item
Yes (Y)
CL Item
No (N)
Item Group
MODIFIED MEDICAL RESEARCH COUNCIL DYSPNOEA SCALE
C3826977 (UMLS CUI-1)
Item
Which ONE of these situations best applies to the subject?
integer
C0013404 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
CL Item
Not troubled with breathlessness except with strenuous exercise (0)
CL Item
Troubled by shortness of breath when hurrying on the level or walking up a slight hill (1)
CL Item
Walks slower than people of the same age on the level because of breathlessness or has to stop for (2)
CL Item
breath when walking at own pace on the level (4)
CL Item
Stops to breathe after walking about 100 yards (100 meters) or after a few minutes on the level (3)
CL Item
Too breathless to leave the house or breathless when dressing or undressing (4)
date of ECG
Item
Date of ECG
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C1623258 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
Item
Did the subject take any bronchodilators prior to these lung function measurements?
text
C0006280 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,3])
Code List
Did the subject take any bronchodilators prior to these lung function measurements?
CL Item
Yes (Y)
CL Item
No (N)
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])
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])
C0242485 (UMLS CUI [1,2])
predicted normal FEV1
Item
Predicted Normal
float
C0205307 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0802965 (UMLS CUI [1,3])
C0024119 (UMLS CUI [1,4])
C0456984 (UMLS CUI [1,2])
C0802965 (UMLS CUI [1,3])
C0024119 (UMLS CUI [1,4])
percent predicted normal
Item
% Predicted Normal
float
C2239179 (UMLS CUI [1])
measurement 30 minutes after Ventolin
Item
Actual Measurement 30 minutes PostVENTOLIN
float
C0033744 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
C0242485 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
FEV1 Reversibility
Item
% Reversibility
integer
C3830088 (UMLS CUI [1])
measurement before Ventolin
Item
Actual Measurement PreVENTOLIN
float
C0033744 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,2])
measurement 30 minutes after Ventolin
Item
Actual Measurement 30 minutes PostVENTOLIN
float
C0033744 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
C0242485 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
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])
C0242485 (UMLS CUI [1,2])
measurement 30 minutes after Ventolin
Item
Actual Measurement 30 minutes PostVENTOLIN
float
C0033744 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
C0242485 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
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])
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])
blood sample taken
Item
Date sample taken
date
C1277698 (UMLS CUI [1])
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])
BDI instrument signed and dated
Item
Confirm the BDI instrument has been signed and dated
boolean
C1511069 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519316 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])