ID

24604

Beschrijving

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

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Versies (2)
  1. 06-08-17 06-08-17 -
  2. 08-08-17 08-08-17 -
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8 augustus 2017

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

Engels

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

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

subject identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
investigational product
Beschrijving

investigational product

Alias
UMLS CUI-1
C0304229
Start Date
Beschrijving

Day Month Year

Datatype

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschrijving

Day Month Year

Datatype

date

Alias
UMLS CUI [1]
C0806020
INVESTIGATIONAL PRODUCT COMPLIANCE
Beschrijving

INVESTIGATIONAL PRODUCT COMPLIANCE

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

date investigational product dispensed

Datatype

date

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

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

Datatype

integer

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

INVESTIGATIONAL PRODUCT COMPLIANCE

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

date investigational product dispensed

Datatype

date

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

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

Datatype

integer

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

INVESTIGATIONAL PRODUCT COMPLIANCE

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

date investigational product dispensed

Datatype

date

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

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

Datatype

integer

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

INVESTIGATIONAL PRODUCT COMPLIANCE

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

date investigational product dispensed

Datatype

date

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

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

Datatype

integer

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

STATUS OF TREATMENT BLIND

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

treatment status of blinded clinical study

Datatype

text

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

if treatment blind broken during the study

Datatype

date

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

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

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
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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