ID

24604

Beschreibung

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

Stichworte

Versionen (2)
  1. 06.08.17 06.08.17 -
  2. 08.08.17 08.08.17 -
Hochgeladen am

8. August 2017

DOI

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

Englisch

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

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

subject identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
investigational product
Beschreibung

investigational product

Alias
UMLS CUI-1
C0304229
Start Date
Beschreibung

Day Month Year

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschreibung

Day Month Year

Datentyp

date

Alias
UMLS CUI [1]
C0806020
INVESTIGATIONAL PRODUCT COMPLIANCE
Beschreibung

INVESTIGATIONAL PRODUCT COMPLIANCE

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

date investigational product dispensed

Datentyp

date

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

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

Datentyp

integer

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

INVESTIGATIONAL PRODUCT COMPLIANCE

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

date investigational product dispensed

Datentyp

date

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

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

Datentyp

integer

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

INVESTIGATIONAL PRODUCT COMPLIANCE

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

date investigational product dispensed

Datentyp

date

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

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

Datentyp

integer

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

INVESTIGATIONAL PRODUCT COMPLIANCE

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

date investigational product dispensed

Datentyp

date

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

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

Datentyp

integer

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

STATUS OF TREATMENT BLIND

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

treatment status of blinded clinical study

Datentyp

text

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

if treatment blind broken during the study

Datentyp

date

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

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

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C2347038
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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