ID

24754

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 (3)
  1. 2017-08-16 2017-08-16 -
  2. 2017-08-16 2017-08-16 -
  3. 2017-08-16 2017-08-16 -
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16 augusti 2017

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Creative Commons BY-NC 3.0
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daily record card documentation salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

Engelsk

daily record card documentation salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

subject identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Description
Beskrivning

visit description

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
Day
Beskrivning

day of record

Datatyp

integer

Alias
UMLS CUI [1]
C0439228
documentation of health status
Beskrivning

documentation of health status

Alias
UMLS CUI-1
C0683314
UMLS CUI-2
C0920316
Date
Beskrivning

date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Morning Peak Flow Reading
Beskrivning

Highest of 3 readings

Datatyp

integer

Alias
UMLS CUI [1]
C0521299
Did you take VENTOLIN in the 6 hours prior to your peak flow reading?
Beskrivning

taken ventolin before peak flow measurement

Datatyp

text

Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C0521299
Number of night-time awakenings due to your COPD
Beskrivning

night time awakening due to COPD

Datatyp

integer

Alias
UMLS CUI [1,1]
C4062814
UMLS CUI [1,2]
C0024117
Number of occasions (not puffs) VENTOLIN was used in the previous 24 hours?
Beskrivning

number of occasions ventolin was used in last 24 hours

Datatyp

integer

Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C1442770
How many days did you miss from work or usual activities in the previous 24 hours, due to worsening of your COPD symptoms?
Beskrivning

nuber of days missed work or unable to perform usual activities in last 24 hours due to COPD worsening

Datatyp

text

Alias
UMLS CUI [1,1]
C0559457
UMLS CUI [1,2]
C3827729
UMLS CUI [1,3]
C1442770
UMLS CUI [1,4]
C0024117
COPD Symptoms
Beskrivning

COPD Symptoms

Alias
UMLS CUI-1
C0559457
UMLS CUI-2
C1457887
Breathlessness
Beskrivning

none/not at all = 0 100 = worst symptoms experienced or as bad as it can be

Datatyp

integer

Alias
UMLS CUI [1]
C0013404
Activity limitation
Beskrivning

none/not at all = 0 100 = worst symptoms experienced or as bad as it can be

Datatyp

integer

Alias
UMLS CUI [1,1]
C0026606
UMLS CUI [1,2]
C0449295
Cough
Beskrivning

none/not at all = 0 100 = worst symptoms experienced or as bad as it can be

Datatyp

integer

Alias
UMLS CUI [1]
C0010200
Sleep quality (trouble sleeping?)
Beskrivning

none/not at all = 0 100 = worst symptoms experienced or as bad as it can be

Datatyp

integer

Alias
UMLS CUI [1]
C0424563
VAS Total
Beskrivning

VAS score

Datatyp

integer

Alias
UMLS CUI [1]
C3536884
WORKSHEET
Beskrivning

WORKSHEET

Alias
UMLS CUI-1
C2349155
Start Date
Beskrivning

start date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Medical Problem
Beskrivning

patient's problem

Datatyp

text

Alias
UMLS CUI [1]
C1254481
Treatment Taken
Beskrivning

treatment

Datatyp

text

Alias
UMLS CUI [1]
C0087111
Monitor’s signature
Beskrivning

signature

Datatyp

text

Alias
UMLS CUI [1]
C1519316
Date
Beskrivning

date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
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Similar models

daily record card documentation salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Visit Description
text
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
visit description
Code List
Visit Description
CL Item
run-in period (RUN-IN PERIOD)
CL Item
treatment period visit 2 (TREATMENT PERIOD Visit 2)
CL Item
treatment period visit 3 (TREATMENT PERIOD Visit 3)
CL Item
treatment period visit 4 (TREATMENT PERIOD Visit 4)
CL Item
treatment period visit 5 (TREATMENT PERIOD Visit 5)
CL Item
treatment period visit 6 (TREATMENT PERIOD Visit 6)
CL Item
treatment period visit 7 (TREATMENT PERIOD Visit 7)
Item
Day
integer
C0439228 (UMLS CUI [1])
day of record
Code List
Day
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
CL Item
Day 7 (7)
CL Item
Day 8 (8)
CL Item
Day 9 (9)
CL Item
Day 10 (10)
CL Item
Day 11 (11)
CL Item
Day 12 (12)
CL Item
Day 13 (13)
CL Item
Day 14 (14)
CL Item
Day 15 (15)
CL Item
Day 16 (16)
CL Item
Day 17 (17)
CL Item
Day 18 (18)
CL Item
Day 19 (19)
CL Item
Day 20 (20)
CL Item
Day 21 (21)
CL Item
Day 22 (22)
CL Item
Day 23 (23)
CL Item
Day 24 (24)
CL Item
Day 25 (25)
CL Item
Day 26 (26)
CL Item
Day 27 (27)
CL Item
Day 28 (28)
CL Item
Day 29 (29)
CL Item
Day 30 (30)
CL Item
Day 31 (31)
Item Group
documentation of health status
C0683314 (UMLS CUI-1)
C0920316 (UMLS CUI-2)
date
Item
Date
date
C0011008 (UMLS CUI [1])
peak flow
Item
Morning Peak Flow Reading
integer
C0521299 (UMLS CUI [1])
Item
Did you take VENTOLIN in the 6 hours prior to your peak flow reading?
text
C0033744 (UMLS CUI [1,1])
C0521299 (UMLS CUI [1,2])
taken ventolin before peak flow measurement
Code List
Did you take VENTOLIN in the 6 hours prior to your peak flow reading?
CL Item
Yes (Y)
CL Item
No (N)
night time awakening due to COPD
Item
Number of night-time awakenings due to your COPD
integer
C4062814 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
number of occasions ventolin was used in last 24 hours
Item
Number of occasions (not puffs) VENTOLIN was used in the previous 24 hours?
integer
C0033744 (UMLS CUI [1,1])
C1442770 (UMLS CUI [1,2])
Item
How many days did you miss from work or usual activities in the previous 24 hours, due to worsening of your COPD symptoms?
text
C0559457 (UMLS CUI [1,1])
C3827729 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
C0024117 (UMLS CUI [1,4])
nuber of days missed work or unable to perform usual activities in last 24 hours due to COPD worsening
Code List
How many days did you miss from work or usual activities in the previous 24 hours, due to worsening of your COPD symptoms?
CL Item
0 (0)
CL Item
1/2 (1/2)
CL Item
1 (1)
Item Group
COPD Symptoms
C0559457 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
dyspnoea
Item
Breathlessness
integer
C0013404 (UMLS CUI [1])
physical activity limitation
Item
Activity limitation
integer
C0026606 (UMLS CUI [1,1])
C0449295 (UMLS CUI [1,2])
coughing
Item
Cough
integer
C0010200 (UMLS CUI [1])
sleep quality
Item
Sleep quality (trouble sleeping?)
integer
C0424563 (UMLS CUI [1])
VAS score
Item
VAS Total
integer
C3536884 (UMLS CUI [1])
Item Group
WORKSHEET
C2349155 (UMLS CUI-1)
start date
Item
Start Date
date
C0808070 (UMLS CUI [1])
patient's problem
Item
Medical Problem
text
C1254481 (UMLS CUI [1])
treatment
Item
Treatment Taken
text
C0087111 (UMLS CUI [1])
signature
Item
Monitor’s signature
text
C1519316 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
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