ID

24594

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 (3)
  1. 27.07.17 27.07.17 -
  2. 27.07.17 27.07.17 -
  3. 08.08.17 08.08.17 -
Hochgeladen am

8. August 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

visit 2 (randomisation) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

Englisch

visit 2 (randomisation) 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
Visit Date
Beschreibung

date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
CURRENT TOBACCO USE
Beschreibung

CURRENT TOBACCO USE

Alias
UMLS CUI-1
C0543414
Has the subject smoked/used tobacco since the last visit?
Beschreibung

use of tobacco since last visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1517741
BASELINE DYSPNOEA INDEX (BDI)
Beschreibung

BASELINE DYSPNOEA INDEX (BDI)

Alias
UMLS CUI-1
C1511069
OROPHARYNGEAL CANDIDIASIS EXAMINATION
Beschreibung

OROPHARYNGEAL CANDIDIASIS EXAMINATION

Alias
UMLS CUI-1
C0006849
UMLS CUI-2
C0582103
Does the subject have clinical evidence of oropharyngeal candidiasis?
Beschreibung

clinical evidence of oropharyngeal candidiasis

Datentyp

text

Alias
UMLS CUI [1,1]
C0006849
UMLS CUI [1,2]
C3887511
Was a swab taken?
Beschreibung

Swab need only be taken if there is clinical evidence of oropharyngeal candidiasis

Datentyp

text

Alias
UMLS CUI [1,1]
C0006849
UMLS CUI [1,2]
C0563454
if a swab was taken, result of the swab?
Beschreibung

oropharyngeal candidiasis test result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0006849
UMLS CUI [1,2]
C0563454
UMLS CUI [1,3]
C1274040
VITAL SIGNS
Beschreibung

VITAL SIGNS

Alias
UMLS CUI-1
C0518766
Blood pressure
Beschreibung

Position: sitting.

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Beschreibung

heart rate

Datentyp

integer

Maßeinheiten
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute
PULMONARY FUNCTION TESTING
Beschreibung

PULMONARY FUNCTION TESTING

Alias
UMLS CUI-1
C0024119
Has the subject taken VENTOLIN in the last 6 hours?
Beschreibung

ventolin taken in the last hours

Datentyp

text

Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C1632850
pulmonary funtion testing: FEV1
Beschreibung

pulmonary funtion testing: FEV1

Alias
UMLS CUI-1
C0748133
Time of Assessment PreVENTOLIN
Beschreibung

time of assessment before Ventolin

Datentyp

time

Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0220825
Actual Measurement PreVENTOLIN
Beschreibung

Actual Measurement PreVENTOLIN = A

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C0242485
L
pulmonary function testing: FVC
Beschreibung

pulmonary function testing: FVC

Alias
UMLS CUI-1
C3714541
Actual Measurement PreVENTOLIN
Beschreibung

Actual Measurement PreVENTOLIN = A

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C0242485
L
pulmonary function testing: FEV1 /FVC ratio
Beschreibung

pulmonary function testing: FEV1 /FVC ratio

Alias
UMLS CUI-1
C0429745
Actual Measurement PreVENTOLIN
Beschreibung

Actual Measurement PreVENTOLIN = A

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0033744
UMLS CUI [1,2]
C0242485
L
ST. GEORGE’S RESPIRATORY QUESTIONNAIRE
Beschreibung

ST. GEORGE’S RESPIRATORY QUESTIONNAIRE

Alias
UMLS CUI-1
C0451500
Confirm the SGRQ has been completed by the subject
Beschreibung

SGRQ completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0451500
UMLS CUI [1,2]
C0205197
EQ-5D (Euroqol)
Beschreibung

EQ-5D (Euroqol)

Alias
UMLS CUI-1
C2733251
Confirm the EQ-5D has been completed by the subject.
Beschreibung

EQ-5D completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2733251
UMLS CUI [1,2]
C0205197
RANDOMISATION NUMBER
Beschreibung

RANDOMISATION NUMBER

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Record randomisation number.
Beschreibung

randomisation number

Datentyp

float

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
INVESTIGATIONAL PRODUCT CONTAINER NUMBER
Beschreibung

INVESTIGATIONAL PRODUCT CONTAINER NUMBER

Alias
UMLS CUI-1
C3898691
UMLS CUI-2
C0449788
Record the identifying number from the investigational product container dispensed at this visit.
Beschreibung

investigational product containernumber

Datentyp

integer

Alias
UMLS CUI [1,1]
C3898691
UMLS CUI [1,2]
C0449788
TRANSITION DYSPNOEA INDEX (TDI)
Beschreibung

TRANSITION DYSPNOEA INDEX (TDI)

Alias
UMLS CUI-1
C3714807
Zum Seitenanfang zurückkehren

Ähnliche Modelle

visit 2 (randomisation) 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])
date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
CURRENT TOBACCO USE
C0543414 (UMLS CUI-1)
Item
Has the subject smoked/used tobacco since the last visit?
text
C0543414 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
use of tobacco since last visit
Code List
Has the subject smoked/used tobacco since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
BASELINE DYSPNOEA INDEX (BDI)
C1511069 (UMLS CUI-1)
Item Group
OROPHARYNGEAL CANDIDIASIS EXAMINATION
C0006849 (UMLS CUI-1)
C0582103 (UMLS CUI-2)
Item
Does the subject have clinical evidence of oropharyngeal candidiasis?
text
C0006849 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
clinical evidence of oropharyngeal candidiasis
Code List
Does the subject have clinical evidence of oropharyngeal candidiasis?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was a swab taken?
text
C0006849 (UMLS CUI [1,1])
C0563454 (UMLS CUI [1,2])
taking of a swab
Code List
Was a swab taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
if a swab was taken, result of the swab?
integer
C0006849 (UMLS CUI [1,1])
C0563454 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
oropharyngeal candidiasis test result
Code List
if a swab was taken, result of the swab?
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not available (4)
Item Group
VITAL SIGNS
C0518766 (UMLS CUI-1)
blood pressure
Item
Blood pressure
integer
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
PULMONARY FUNCTION TESTING
C0024119 (UMLS CUI-1)
Item
Has the subject taken VENTOLIN in the last 6 hours?
text
C0033744 (UMLS CUI [1,1])
C1632850 (UMLS CUI [1,2])
use of bronchodilatators before lung function measurement
Code List
Has the subject taken VENTOLIN in the last 6 hours?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
pulmonary funtion testing: FEV1
C0748133 (UMLS CUI-1)
time of assessment before Ventolin
Item
Time of Assessment PreVENTOLIN
time
C0033744 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
measurement before Ventolin
Item
Actual Measurement PreVENTOLIN
float
C0033744 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Item Group
pulmonary function testing: FVC
C3714541 (UMLS CUI-1)
measurement before Ventolin
Item
Actual Measurement PreVENTOLIN
float
C0033744 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Item Group
pulmonary function testing: FEV1 /FVC ratio
C0429745 (UMLS CUI-1)
measurement before Ventolin
Item
Actual Measurement PreVENTOLIN
float
C0033744 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Item Group
ST. GEORGE’S RESPIRATORY QUESTIONNAIRE
C0451500 (UMLS CUI-1)
SGRQ completed
Item
Confirm the SGRQ has been completed by the subject
boolean
C0451500 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item Group
EQ-5D (Euroqol)
C2733251 (UMLS CUI-1)
EQ-5D completed
Item
Confirm the EQ-5D has been completed by the subject.
boolean
C2733251 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item Group
RANDOMISATION NUMBER
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
randomisation number
Item
Record randomisation number.
float
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
INVESTIGATIONAL PRODUCT CONTAINER NUMBER
C3898691 (UMLS CUI-1)
C0449788 (UMLS CUI-2)
investigational product containernumber
Item
Record the identifying number from the investigational product container dispensed at this visit.
integer
C3898691 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
TRANSITION DYSPNOEA INDEX (TDI)
C3714807 (UMLS CUI-1)
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video