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24532
Beschreibung
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
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- 05.08.17 05.08.17 -
- 08.08.17 08.08.17 -
Rechteinhaber
.GlaxoSmithKline
Hochgeladen am
5. August 2017
DOI
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Creative Commons BY-NC 3.0
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withdrawal salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470
withdrawal salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470
Ähnliche Modelle
withdrawal salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
CL Item
Yes (Y)
CL Item
No (N)
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)
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])
blood pressure
Item
Blood pressure
integer
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (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])
C1632850 (UMLS CUI [1,2])
Code List
Has the subject taken VENTOLIN in the last 6 hours?
CL Item
Yes (Y)
CL Item
No (N)
time of pre-dose measurement
Item
Time of Assessment Pre-dose
time
C3812758 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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])
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])
C0242485 (UMLS CUI [1,2])
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])
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])
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])
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)
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])
C1516048 (UMLS CUI [1,2])
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])
C1516048 (UMLS CUI [1,2])
C2826299 (UMLS CUI [1,3])
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)