ID

24616

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 (2)
  1. 8/8/17 8/8/17 -
  2. 8/8/17 8/8/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 8, 2017

DOI

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License

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

English

study conclusion events 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
STUDY CONCLUSION
Description

STUDY CONCLUSION

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or withdrawal.
Description

end of study

Data type

date

Alias
UMLS CUI [1]
C2983670
Was the subject withdrawn from the study?
Description

subject withdrawn from study

Data type

text

Alias
UMLS CUI [1]
C0422727
If "yes" to patient withdram from study, record the primary reason for withdrawal.
Description

patient withdrawn from study

Data type

text

Alias
UMLS CUI [1]
C0422727
MEDICAL DEVICE QUESTION
Description

MEDICAL DEVICE QUESTION

Alias
UMLS CUI-1
C0025080
Did the subject experience an incident or near-incident with GSK medical devices provided for use during this study?
Description

If Yes, complete the Medical Device Incident Report Form.

Data type

text

Alias
UMLS CUI [1,1]
C0025080
UMLS CUI [1,2]
C1551358
PREGNANCY INFORMATION
Description

PREGNANCY INFORMATION

Alias
UMLS CUI-1
C0032961
Did the subject become pregnant during the study?
Description

If Yes, complete Pregnancy Notification form.

Data type

text

Alias
UMLS CUI [1]
C0032961
INVESTIGATOR COMMENT LOG
Description

INVESTIGATOR COMMENT LOG

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
CRF page number if applicable
Description

page number of case report

Data type

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Description

investigator's comment

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0008961
INVESTIGATOR’S SIGNATURE
Description

INVESTIGATOR’S SIGNATURE

Alias
UMLS CUI-1
C2346576
Investigator’s signature
Description

investigator's signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator´s name (print)
Description

Investigator´s name

Data type

text

Alias
UMLS CUI [1]
C2826892
Date
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

study conclusion events 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
STUDY CONCLUSION
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
end of study
Item
Date of subject completion or withdrawal.
date
C2983670 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
subject withdrawn from study
Code List
Was the subject withdrawn from the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
If "yes" to patient withdram from study, record the primary reason for withdrawal.
text
C0422727 (UMLS CUI [1])
patient withdrawn from study
Code List
If "yes" to patient withdram from study, record the primary reason for withdrawal.
CL Item
Adverse event (1)
CL Item
Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. (Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate.)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Lack of efficacy (5)
CL Item
Exacerbation (14)
CL Item
Did not meet treatment elig bility criteria (24)
CL Item
Other, specify _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ (Z)
Item Group
MEDICAL DEVICE QUESTION
C0025080 (UMLS CUI-1)
Item
Did the subject experience an incident or near-incident with GSK medical devices provided for use during this study?
text
C0025080 (UMLS CUI [1,1])
C1551358 (UMLS CUI [1,2])
incident with medical devices
Code List
Did the subject experience an incident or near-incident with GSK medical devices provided for use during this study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
PREGNANCY INFORMATION
C0032961 (UMLS CUI-1)
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1])
pregnancy
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (not of childbearing potential or male) (X)
Item Group
INVESTIGATOR COMMENT LOG
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
page number of case report
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
investigator's comment
Item
Comment
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Item Group
INVESTIGATOR’S SIGNATURE
C2346576 (UMLS CUI-1)
investigator's signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Investigator´s name
Item
Investigator´s name (print)
text
C2826892 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
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