ID

24571

Descrição

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

Palavras-chave

Versões (3)
  1. 06/08/2017 06/08/2017 -
  2. 08/08/2017 08/08/2017 -
  3. 08/08/2017 08/08/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

6 août 2017

DOI

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Licença

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

Inglês

concomitant medication salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 Formulários  
COPD CONCOMITANT MEDICATIONS
Descrição

COPD CONCOMITANT MEDICATIONS

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0024117
Were any COPD concomitant medications taken by the subject prior to screening and/or during the study?
Descrição

COPD concomitant medication

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0024117
If "yes" to COPD concomitant medication, record each medication separately by fulfilling the following items.
Descrição

If "yes" to COPD concomitant medication, record each medication separately by fulfilling the following items.

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0024117
Drug Name
Descrição

Trade name preferred.

Tipo de dados

text

Alias
UMLS CUI [1]
C2360065
Unit Dose
Descrição

unit dose

Tipo de dados

integer

Alias
UMLS CUI [1]
C0869039
Unit
Descrição

units of medication

Tipo de dados

integer

Alias
UMLS CUI [1]
C1519795
Frequency
Descrição

frequency of medication

Tipo de dados

text

Alias
UMLS CUI [1]
C3476109
Route
Descrição

medication routes

Tipo de dados

text

Alias
UMLS CUI [1]
C0013153
Start Date
Descrição

start date of medication

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Taken prior to study?
Descrição

medication taken prior to study

Tipo de dados

text

Alias
UMLS CUI [1]
C2826667
Stop Date
Descrição

stop date of medication

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Ongoing medication?
Descrição

concomitant medication ongoing

Tipo de dados

text

Alias
UMLS CUI [1]
C2826666
Was drug administered for an exacerbation?
Descrição

drug adminstered for a COPD exacerbation

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C0740304
NON-COPD CONCOMITANT MEDICATIONS
Descrição

NON-COPD CONCOMITANT MEDICATIONS

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject prior to screening and/or during the study?
Descrição

medication that is not COPD-related

Tipo de dados

text

Alias
UMLS CUI [1]
C2347852
If "yes" to non-COPD concomitant medication, record each medication separately by fulfilling the following items.
Descrição

If "yes" to non-COPD concomitant medication, record each medication separately by fulfilling the following items.

Alias
UMLS CUI-1
C2347852
Drug name
Descrição

Trade name preferred.

Tipo de dados

text

Alias
UMLS CUI [1]
C2360065
Unit Dose
Descrição

unit dose

Tipo de dados

integer

Alias
UMLS CUI [1]
C0869039
Unit
Descrição

units of medication

Tipo de dados

integer

Alias
UMLS CUI [1]
C1519795
Frequency
Descrição

frequency of medication

Tipo de dados

text

Alias
UMLS CUI [1]
C3476109
Route
Descrição

medication routes

Tipo de dados

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Descrição

reason for medication

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Start Date
Descrição

start date of medication

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Taken prior to study?
Descrição

medication taken prior to study

Tipo de dados

text

Alias
UMLS CUI [1]
C2826667
Stop Date
Descrição

stop date of medication

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Ongoing medication?
Descrição

concomitant medication ongoing

Tipo de dados

text

Alias
UMLS CUI [1]
C2826666
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Similar models

concomitant medication salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
COPD CONCOMITANT MEDICATIONS
C2347852 (UMLS CUI-1)
C0024117 (UMLS CUI-2)
Item
Were any COPD concomitant medications taken by the subject prior to screening and/or during the study?
text
C2347852 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
COPD concomitant medication
Code List
Were any COPD concomitant medications taken by the subject prior to screening and/or during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
If "yes" to COPD concomitant medication, record each medication separately by fulfilling the following items.
C2347852 (UMLS CUI-1)
C0024117 (UMLS CUI-2)
medication name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
unit dose
Item
Unit Dose
integer
C0869039 (UMLS CUI [1])
units of medication
Item
Unit
integer
C1519795 (UMLS CUI [1])
frequency of medication
Item
Frequency
text
C3476109 (UMLS CUI [1])
medication routes
Item
Route
text
C0013153 (UMLS CUI [1])
start date of medication
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Taken prior to study?
text
C2826667 (UMLS CUI [1])
medication taken prior to study
Code List
Taken prior to study?
CL Item
Yes (Y)
CL Item
No (N)
stop date of medication
Item
Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Ongoing medication?
text
C2826666 (UMLS CUI [1])
concomitant medication ongoing
Code List
Ongoing medication?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was drug administered for an exacerbation?
text
C3469597 (UMLS CUI [1,1])
C0740304 (UMLS CUI [1,2])
drug adminstered for a COPD exacerbation
Code List
Was drug administered for an exacerbation?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
NON-COPD CONCOMITANT MEDICATIONS
C2347852 (UMLS CUI-1)
Item
Were any concomitant medications taken by the subject prior to screening and/or during the study?
text
C2347852 (UMLS CUI [1])
concomitant medication
Code List
Were any concomitant medications taken by the subject prior to screening and/or during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
If "yes" to non-COPD concomitant medication, record each medication separately by fulfilling the following items.
C2347852 (UMLS CUI-1)
medication name
Item
Drug name
text
C2360065 (UMLS CUI [1])
unit dose
Item
Unit Dose
integer
C0869039 (UMLS CUI [1])
units of medication
Item
Unit
integer
C1519795 (UMLS CUI [1])
frequency of medication
Item
Frequency
text
C3476109 (UMLS CUI [1])
medication routes
Item
Route
text
C0013153 (UMLS CUI [1])
reason for medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
start date of medication
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Taken prior to study?
text
C2826667 (UMLS CUI [1])
medication taken prior to study
Code List
Taken prior to study?
CL Item
Yes (Y)
CL Item
No (N)
stop date of medication
Item
Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Ongoing medication?
text
C2826666 (UMLS CUI [1])
concomitant medication ongoing
Code List
Ongoing medication?
CL Item
Yes (Y)
CL Item
No (N)
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