ID

24570

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. 8/6/17 8/6/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 6, 2017

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License

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

English

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

1 forms  
COPD EXACERBATIONS
Description

COPD EXACERBATIONS

Alias
UMLS CUI-1
C0740304
Was there a COPD exacerbation?
Description

COPD exacerbation

Data type

text

Alias
UMLS CUI [1]
C0740304
If "yes" to COPD exacerbation, record following items.
Description

If "yes" to COPD exacerbation, record following items.

Alias
UMLS CUI-1
C0740304
Date of Onset
Description

date of onset of COPD exacerbation

Data type

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0740304
Outcome
Description

outcome of COPD exacerbation

Data type

integer

Alias
UMLS CUI [1,1]
C0085565
UMLS CUI [1,2]
C0740304
Date of Resolution or Death
Description

date of resolution or death

Data type

date

Alias
UMLS CUI [1]
C2985858
UMLS CUI [2]
C1148348
Severity
Description

severity of COPD excerbation

Data type

integer

Alias
UMLS CUI [1,1]
C0439793
UMLS CUI [1,2]
C0740304
Was the subject withdrawn due to this exacerbation?
Description

Subjects who experience more than one moderate exacerbation requiring antibiotic and/or oral corticosteroid treatment during the treatment period and/or experience a severe exacerbation requiring hospitalisation during the course of the study must be withdrawn.

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0740304
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
COPD EXACERBATIONS
C0740304 (UMLS CUI-1)
Item
Was there a COPD exacerbation?
text
C0740304 (UMLS CUI [1])
COPD exacerbation
Code List
Was there a COPD exacerbation?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
If "yes" to COPD exacerbation, record following items.
C0740304 (UMLS CUI-1)
date of onset of COPD exacerbation
Item
Date of Onset
date
C0574845 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
Item
Outcome
integer
C0085565 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
outcome of COPD exacerbation
Code List
Outcome
CL Item
Resolved (1)
CL Item
Fatal (2)
CL Item
Not resolved (3)
date of resolution or death
Item
Date of Resolution or Death
date
C2985858 (UMLS CUI [1])
C1148348 (UMLS CUI [2])
Item
Severity
integer
C0439793 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
severity of COPD excerbation
Code List
Severity
CL Item
moderate (2)
CL Item
severe (3)
Item
Was the subject withdrawn due to this exacerbation?
text
C0422727 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
subject withdrawn due to this COPD exacerbation
Code List
Was the subject withdrawn due to this exacerbation?
CL Item
Yes (Y)
CL Item
No (N)
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