ID

24556

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

GlaxoSmithKline

Transferido a

6 de agosto de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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investigational product and blinded study salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

Inglês

investigational product and blinded study salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

1 Formulários  
investigational product
Descrição

investigational product

Alias
UMLS CUI-1
C0304229
Start Date
Descrição

Day Month Year

Tipo de dados

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Descrição

Day Month Year

Tipo de dados

date

Alias
UMLS CUI [1]
C0806020
INVESTIGATIONAL PRODUCT COMPLIANCE
Descrição

INVESTIGATIONAL PRODUCT COMPLIANCE

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
Date Investigational Product Dispensed
Descrição

date investigational product dispensed

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0808070
Dose Counter Stop
Descrição

Note dose for each Double-Blind Diskus 1, 2, 3 separately.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C0806020
INVESTIGATIONAL PRODUCT COMPLIANCE
Descrição

INVESTIGATIONAL PRODUCT COMPLIANCE

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
Date Investigational Product Dispensed
Descrição

date investigational product dispensed

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0808070
Dose Counter Stop
Descrição

Note dose for each Double-Blind Diskus 1, 2, 3 separately.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C0806020
INVESTIGATIONAL PRODUCT COMPLIANCE
Descrição

INVESTIGATIONAL PRODUCT COMPLIANCE

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
Date Investigational Product Dispensed
Descrição

date investigational product dispensed

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0808070
Dose Counter Stop
Descrição

Note dose for each Double-Blind Diskus 1, 2, 3 separately.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C0806020
INVESTIGATIONAL PRODUCT COMPLIANCE
Descrição

INVESTIGATIONAL PRODUCT COMPLIANCE

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
Date Investigational Product Dispensed
Descrição

date investigational product dispensed

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0808070
Dose Counter Stop
Descrição

Note dose for each Double-Blind Diskus 1, 2, 3 separately.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C0806020
STATUS OF TREATMENT BLIND
Descrição

STATUS OF TREATMENT BLIND

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Descrição

treatment status of blinded clinical study

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
Date blind broken
Descrição

if treatment blind broken during the study

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2347038
UMLS CUI [1,2]
C0011008
Reason blind broken
Descrição

if treatment blind broken during the study if "other reason", specify that

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C2347038
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Similar models

investigational product and blinded study 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
investigational product
C0304229 (UMLS CUI-1)
start date
Item
Start Date
date
C0808070 (UMLS CUI [1])
stop date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item Group
INVESTIGATIONAL PRODUCT COMPLIANCE
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
date investigational product dispensed
Item
Date Investigational Product Dispensed
date
C0013230 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
product dose at end of treatment
Item
Dose Counter Stop
integer
C0678766 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
INVESTIGATIONAL PRODUCT COMPLIANCE
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
date investigational product dispensed
Item
Date Investigational Product Dispensed
date
C0013230 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
product dose at end of treatment
Item
Dose Counter Stop
integer
C0678766 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
INVESTIGATIONAL PRODUCT COMPLIANCE
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
date investigational product dispensed
Item
Date Investigational Product Dispensed
date
C0013230 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
product dose at end of treatment
Item
Dose Counter Stop
integer
C0678766 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
INVESTIGATIONAL PRODUCT COMPLIANCE
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
date investigational product dispensed
Item
Date Investigational Product Dispensed
date
C0013230 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
product dose at end of treatment
Item
Dose Counter Stop
integer
C0678766 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
STATUS OF TREATMENT BLIND
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Item
Was the treatment blind broken during the study?
text
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
treatment status of blinded clinical study
Code List
Was the treatment blind broken during the study?
CL Item
Yes (Y)
CL Item
No (N)
date of blind broken in clinical study
Item
Date blind broken
date
C2347038 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
subject unblinding event record in blinded clinical study
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (Z)
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