ID

24596

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

Mots-clés

Versions (2)
  1. 27/07/2017 27/07/2017 -
  2. 08/08/2017 08/08/2017 -
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8 août 2017

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Licence

Creative Commons BY-NC 3.0
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visit 2 (inclusion/exclusion criteria) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

Anglais

visit 2 (inclusion/exclusion criteria) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 Formulaires  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

subject identifier

Type de données

integer

Alias
UMLS CUI [1]
C2348585
ELIGIBILITY QUESTION
Description

ELIGIBILITY QUESTION

Alias
UMLS CUI-1
C0013893
Did the subject meet all the randomisation criteria?
Description

randomisation criteria

Type de données

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0243161
INCLUSION CRITERIA
Description

INCLUSION CRITERIA

Alias
UMLS CUI-1
C1512693
Achieves a BDI focal score of ≤ 7 units at Visit 2
Description

baseline dysnpnoea index

Type de données

boolean

Alias
UMLS CUI [1]
C1511069
Achieves a composite VAS score of ≥120 (out of 400 maximum) on 4 or more days over the 7 days immediately prior to Visit 2.
Description

VAS referring to COPD symptoms

Type de données

boolean

Alias
UMLS CUI [1,1]
C3536884
UMLS CUI [1,2]
C1737716
Is able to complete a Daily Record Card.
Description

ability of daily documentation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0920316
UMLS CUI [1,2]
C0332173
UMLS CUI [1,3]
C0085732
Is able to demonstrate correct use of DISKUS/ACCUHALER.
Description

ability to show the correct inhaler technique

Type de données

boolean

Alias
UMLS CUI [1]
C0419833
EXCLUSION CRITERIA
Description

EXCLUSION CRITERIA

Alias
UMLS CUI-1
C0680251
Has less than 4 consecutive days with complete run-in DRC data within the 7 consecutive days prior to Visit 2.
Description

incomplete documentation of the daily record card

Type de données

boolean

Alias
UMLS CUI [1]
C3845717
Has (in the opinion of the investigator) a clinically significant abnormal clinical haematology and chemistry or cortisol value at Visit 1.
Description

abnormal clinical haematology and chemistry or cortisol level

Type de données

boolean

Alias
UMLS CUI [1]
C1332129
UMLS CUI [2]
C0428396
Has experienced a moderate or severe exacerbation of their COPD during the Run-In period.
Description

COPD exacerbation

Type de données

boolean

Alias
UMLS CUI [1]
C0740304
Subjects who have had a change to their COPD medication or taken non-permitted medications, other than "as required" use of VENTOLIN for the management of COPD exacerbations between Visits 1 and 2.
Description

change in COPD medication or medication other than the permitted

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0580105
UMLS CUI [2]
C1115771
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Similar models

visit 2 (inclusion/exclusion criteria) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
ELIGIBILITY QUESTION
C0013893 (UMLS CUI-1)
Item
Did the subject meet all the randomisation criteria?
text
C0034656 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
randomisation criteria
Code List
Did the subject meet all the randomisation criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
INCLUSION CRITERIA
C1512693 (UMLS CUI-1)
baseline dysnpnoea index
Item
Achieves a BDI focal score of ≤ 7 units at Visit 2
boolean
C1511069 (UMLS CUI [1])
visual analog scale of COPD symptoms
Item
Achieves a composite VAS score of ≥120 (out of 400 maximum) on 4 or more days over the 7 days immediately prior to Visit 2.
boolean
C3536884 (UMLS CUI [1,1])
C1737716 (UMLS CUI [1,2])
ability of daily documentation
Item
Is able to complete a Daily Record Card.
boolean
C0920316 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
ability to show the correct inhaler technique
Item
Is able to demonstrate correct use of DISKUS/ACCUHALER.
boolean
C0419833 (UMLS CUI [1])
Item Group
EXCLUSION CRITERIA
C0680251 (UMLS CUI-1)
incomplete documentation of the daily record card
Item
Has less than 4 consecutive days with complete run-in DRC data within the 7 consecutive days prior to Visit 2.
boolean
C3845717 (UMLS CUI [1])
abnormal clinical haematology and chemistry or cortisol level
Item
Has (in the opinion of the investigator) a clinically significant abnormal clinical haematology and chemistry or cortisol value at Visit 1.
boolean
C1332129 (UMLS CUI [1])
C0428396 (UMLS CUI [2])
COPD exacerbation
Item
Has experienced a moderate or severe exacerbation of their COPD during the Run-In period.
boolean
C0740304 (UMLS CUI [1])
change in COPD medication or medication other than the permitted
Item
Subjects who have had a change to their COPD medication or taken non-permitted medications, other than "as required" use of VENTOLIN for the management of COPD exacerbations between Visits 1 and 2.
boolean
C0024117 (UMLS CUI [1,1])
C0580105 (UMLS CUI [1,2])
C1115771 (UMLS CUI [2])
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