ID

24617

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

Keywords

Versions (1)
  1. 8/8/17 8/8/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 8, 2017

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License

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

English

baseline dyspnoea index salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

subject identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
BASELINE DYSPNOEA INDEX (BDI) WORKSHEET
Description

BASELINE DYSPNOEA INDEX (BDI) WORKSHEET

Alias
UMLS CUI-1
C1511069
Date of assessment
Description

assessment date of baseline dyspnoea index

Data type

date

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1511069
BDI: Job
Description

BDI: Job

Alias
UMLS CUI-1
C0028811
Functional Impairment
Description

types/kinds of activities

Data type

integer

Alias
UMLS CUI [1]
C3827376
Magnitude of Task
Description

level, magnitude, extent

Data type

integer

Alias
UMLS CUI [1]
C3831386
Magnitude of Effort
Description

time needed, pauses, exertion

Data type

integer

Alias
UMLS CUI [1]
C3831387
Housework, shopping
Description

Housework, shopping

Alias
UMLS CUI-1
C1571726
UMLS CUI-3
C0150768
Functional Impairment
Description

types/kinds of activities

Data type

integer

Alias
UMLS CUI [1]
C3827376
Magnitude of Task
Description

level, magnitude, extent

Data type

integer

Alias
UMLS CUI [1]
C3831386
Magnitude of Effort
Description

time needed, pauses, exertion

Data type

integer

Alias
UMLS CUI [1]
C3831387
Leisure activities, gardening
Description

Leisure activities, gardening

Alias
UMLS CUI-1
C0023292
UMLS CUI-3
C0868963
Functional Impairment
Description

types/kinds of activities

Data type

integer

Alias
UMLS CUI [1]
C3827376
Magnitude of Task
Description

level, magnitude, extent

Data type

integer

Alias
UMLS CUI [1]
C3831386
Magnitude of Effort
Description

time needed, pauses, exertion

Data type

integer

Alias
UMLS CUI [1]
C3831387
Social activities
Description

Social activities

Alias
UMLS CUI-1
C0814554
Functional Impairment
Description

types/kinds of activities

Data type

integer

Alias
UMLS CUI [1]
C3827376
Magnitude of Task
Description

level, magnitude, extent

Data type

integer

Alias
UMLS CUI [1]
C3831386
Magnitude of Effort
Description

time needed, pauses, exertion

Data type

integer

Alias
UMLS CUI [1]
C3831387
Washing/dressing
Description

Washing/dressing

Alias
UMLS CUI-1
C0441648
UMLS CUI-3
C0518459
Functional Impairment
Description

types/kinds of activities

Data type

integer

Alias
UMLS CUI [1]
C3827376
Magnitude of Task
Description

level, magnitude, extent

Data type

integer

Alias
UMLS CUI [1]
C3831386
Magnitude of Effort
Description

time needed, pauses, exertion

Data type

integer

Alias
UMLS CUI [1]
C3831387
At rest
Description

At rest

Alias
UMLS CUI-1
C0035253
Functional Impairment
Description

types/kinds of activities

Data type

integer

Alias
UMLS CUI [1]
C3827376
Magnitude of Task
Description

level, magnitude, extent

Data type

integer

Alias
UMLS CUI [1]
C3831386
Magnitude of Effort
Description

time needed, pauses, exertion

Data type

integer

Alias
UMLS CUI [1]
C3831387
Any other
Description

Any other

Alias
UMLS CUI-1
C0205394
Functional Impairment
Description

types/kinds of activities

Data type

integer

Alias
UMLS CUI [1]
C3827376
Magnitude of Task
Description

level, magnitude, extent

Data type

integer

Alias
UMLS CUI [1]
C3831386
Magnitude of Effort
Description

time needed, pauses, exertion

Data type

integer

Alias
UMLS CUI [1]
C3831387
BDI Score
Description

BDI Score

Alias
UMLS CUI-1
C1511069
UMLS CUI-2
C0449820
BDI Total Score
Description

BDI score

Data type

integer

Alias
UMLS CUI [1,1]
C1511069
UMLS CUI [1,2]
C0449820
Functional Impairment
Description

BDI - functional impairment score

Data type

integer

Alias
UMLS CUI [1,1]
C3827376
UMLS CUI [1,2]
C0449820
Magnitude of Task
Description

BDI - magnitude of task score

Data type

integer

Alias
UMLS CUI [1,1]
C3831386
UMLS CUI [1,2]
C0449820
Magnitude of Effort
Description

BDI - magnitude of effort score

Data type

integer

Alias
UMLS CUI [1,1]
C3831387
UMLS CUI [1,2]
C0449820
Date
Description

Date

Alias
UMLS CUI-1
C0011008
Date of assessment
Description

date of assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
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Similar models

baseline dyspnoea index salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
BASELINE DYSPNOEA INDEX (BDI) WORKSHEET
C1511069 (UMLS CUI-1)
assessment date of baseline dyspnoea index
Item
Date of assessment
date
C2985720 (UMLS CUI [1,1])
C1511069 (UMLS CUI [1,2])
Item Group
BDI: Job
C0028811 (UMLS CUI-1)
BDI - functional impairment
Item
Functional Impairment
integer
C3827376 (UMLS CUI [1])
BDI - magnitude of task
Item
Magnitude of Task
integer
C3831386 (UMLS CUI [1])
BDI - magnitude of effort
Item
Magnitude of Effort
integer
C3831387 (UMLS CUI [1])
Item Group
Housework, shopping
C1571726 (UMLS CUI-1)
C0150768 (UMLS CUI-3)
BDI - functional impairment
Item
Functional Impairment
integer
C3827376 (UMLS CUI [1])
BDI - magnitude of task
Item
Magnitude of Task
integer
C3831386 (UMLS CUI [1])
BDI - magnitude of effort
Item
Magnitude of Effort
integer
C3831387 (UMLS CUI [1])
Item Group
Leisure activities, gardening
C0023292 (UMLS CUI-1)
C0868963 (UMLS CUI-3)
BDI - functional impairment
Item
Functional Impairment
integer
C3827376 (UMLS CUI [1])
BDI - magnitude of task
Item
Magnitude of Task
integer
C3831386 (UMLS CUI [1])
BDI - magnitude of effort
Item
Magnitude of Effort
integer
C3831387 (UMLS CUI [1])
Item Group
Social activities
C0814554 (UMLS CUI-1)
BDI - functional impairment
Item
Functional Impairment
integer
C3827376 (UMLS CUI [1])
BDI - magnitude of task
Item
Magnitude of Task
integer
C3831386 (UMLS CUI [1])
BDI - magnitude of effort
Item
Magnitude of Effort
integer
C3831387 (UMLS CUI [1])
Item Group
Washing/dressing
C0441648 (UMLS CUI-1)
C0518459 (UMLS CUI-3)
BDI - functional impairment
Item
Functional Impairment
integer
C3827376 (UMLS CUI [1])
BDI - magnitude of task
Item
Magnitude of Task
integer
C3831386 (UMLS CUI [1])
BDI - magnitude of effort
Item
Magnitude of Effort
integer
C3831387 (UMLS CUI [1])
Item Group
At rest
C0035253 (UMLS CUI-1)
BDI - functional impairment
Item
Functional Impairment
integer
C3827376 (UMLS CUI [1])
BDI - magnitude of task
Item
Magnitude of Task
integer
C3831386 (UMLS CUI [1])
BDI - magnitude of effort
Item
Magnitude of Effort
integer
C3831387 (UMLS CUI [1])
Item Group
Any other
C0205394 (UMLS CUI-1)
BDI - functional impairment
Item
Functional Impairment
integer
C3827376 (UMLS CUI [1])
BDI - magnitude of task
Item
Magnitude of Task
integer
C3831386 (UMLS CUI [1])
BDI - magnitude of effort
Item
Magnitude of Effort
integer
C3831387 (UMLS CUI [1])
Item Group
BDI Score
C1511069 (UMLS CUI-1)
C0449820 (UMLS CUI-2)
BDI score
Item
BDI Total Score
integer
C1511069 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
BDI - functional impairment score
Item
Functional Impairment
integer
C3827376 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
BDI - magnitude of task score
Item
Magnitude of Task
integer
C3831386 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
BDI - magnitude of effort score
Item
Magnitude of Effort
integer
C3831387 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
Date
C0011008 (UMLS CUI-1)
date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
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