ID
26096
Beschreibung
Randomised, open label, two period, crossover study to compare the steroid systemic exposure of Fluticasone Propionate (FP) from FP/Salmeterol (SALM) (500/50) DISKUS and Budesonide (BUD) from BUD/formoterol (FOR).(200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Primary objective:To compare the exposure of the inhaled steroid fluticasone propionate (FP) and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation twice daily (b.i.d.) when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe chronic pulmonary obstructive disease (COPD) population. Secondary objectives:To compare the pharmacokinetics of FP and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation b.i.d. when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe COPD population and to explore further the pharmacokinetics of FP and budesonide.
Stichworte
Versionen (1)
- 09.10.17 09.10.17 -
Rechteinhaber
Glaxo Smith Kline
Hochgeladen am
9. Oktober 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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GSK Study ID 100807 Fluticasone Propionate from SERETIDE™ (500/50) DISKUS™ and Budesonide from Symbicort (200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Main CRF
Main CRF
- StudyEvent: ODM
Beschreibung
lnvestigational Product Treatment Period 1
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3538994
Beschreibung
Subject number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348585
Beschreibung
Morning Dose
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0332170
Beschreibung
Evening Dose
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0587117
Beschreibung
Compliance behavior
Datentyp
text
Alias
- UMLS CUI [1]
- C1321605
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0011008
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0040223
Beschreibung
Number of Inhalations Accuhaler
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0001559
- UMLS CUI [1,2]
- C1705566
Beschreibung
Number of Inhalations BADPI
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0001559
- UMLS CUI [1,2]
- C1705566
Beschreibung
NOTE: A significant change to investigational product includes those situations where a subject does not have the correct number of inhalations from the inhaler as detailed in the protocol.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3845681
- UMLS CUI [1,2]
- C0304229
Beschreibung
Specify Changes
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0443172
- UMLS CUI [1,2]
- C1521902
Beschreibung
lnvestigational Product Treatment Period 2
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3538994
Beschreibung
Subject number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348585
Beschreibung
Morning Dose
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0332170
Beschreibung
Evening Dose
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0587117
Beschreibung
Compliance behavior
Datentyp
text
Alias
- UMLS CUI [1]
- C1321605
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0011008
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0040223
Beschreibung
Number of Inhalations Accuhaler
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0001559
- UMLS CUI [1,2]
- C1705566
Beschreibung
Number of Inhalations BADPI
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0001559
- UMLS CUI [1,2]
- C1705566
Beschreibung
NOTE: A significant change to investigational product includes those situations where a subject does not have the correct number of inhalations from the inhaler as detailed in the protocol.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3845681
- UMLS CUI [1,2]
- C0304229
Beschreibung
Specify Changes
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0443172
- UMLS CUI [1,2]
- C1521902
Beschreibung
Pharmacogenetic Research
Alias
- UMLS CUI-1
- C0031325
Beschreibung
Informed Consent
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
Beschreibung
Date informed consent obtained
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021430
Beschreibung
Informed consent refused
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1705116
Beschreibung
Blood Sample Collection
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005834
Beschreibung
Date sample taken
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
Withdrawal of Consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1707492
Beschreibung
Blood sample destruction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1948029
- UMLS CUI [1,2]
- C0178913
Beschreibung
Blood sample destruction reason
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1948029
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C0392360
Beschreibung
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Concomitant medications during screening period
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1710477
Beschreibung
Drug Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Medication Dose
Datentyp
float
Alias
- UMLS CUI [1]
- C3174092
Beschreibung
Units
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0013227
Beschreibung
e.g.: BID=2 x Daily OD=1 x Daily PRN=As required QID=4 x Daily TID=3 x Daily
Datentyp
text
Alias
- UMLS CUI [1]
- C3476109
Beschreibung
e.g.: EXT=External ID=Intradermal IH=Inhalation IM=Intramuscular IR=Intraarticular IT=Intrathecal IV=Intravenous NA=Intranasal OTH=Other PE=Parenteral PO=Oral PR=Rectal SC=Subcutaneous SL=Sublingual TD=Transdermal TO=Topical UNK=Unknown VA=Vaginal
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Concomitant Medication Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826734
Beschreibung
Started Pre-Study
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0451613
Beschreibung
Concomitant medication start time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C2347852
Beschreibung
Concomitant Medication Stop Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826744
Beschreibung
Ongoing Medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Concomitant medication end time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C2347852
Beschreibung
Condition treated/Indication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C2347852
Beschreibung
If medication is given to treat an adverse event, then the ADVERSE EVENT must be recorded on the NON-SERIOUS ADVERSE EVENT or SERIOUS ADVERSE EVENT page(s) at the back of the CRF.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2981656
Beschreibung
Rescue Medication
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0884980
Beschreibung
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C0877248
Beschreibung
If YES, indicate below
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Diagnosis only (if known) or signs / symptoms (list one per line)
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C0574845
Beschreibung
00:00-23 59
Datentyp
time
Alias
- UMLS CUI [1]
- C0449244
Beschreibung
Maximum Intensity
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Beschreibung
Outcome
Datentyp
text
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C2985918
Beschreibung
Time of resolution
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1]
- C2826658
Beschreibung
Action taken with investigational product
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Beschreibung
Withdrawal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0877248
Beschreibung
Relationship to Investigational Product
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0015127
Beschreibung
Seriousness
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1518404
Beschreibung
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Investigator Identifier
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826689
Beschreibung
Treatment Number
Datentyp
text
Alias
- UMLS CUI [1]
- C1522541
Beschreibung
Subject number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348585
Beschreibung
Serious Adverse Events
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Gender
Datentyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Race
Datentyp
integer
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Serious Adverse Events
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Serious Adverse Event Onset Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2985916
- UMLS CUI [1,2]
- C1519255
Beschreibung
SAE onset time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449244
Beschreibung
Maximum Intensity
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Beschreibung
Outcome SAE
Datentyp
text
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
Date of resolution or death
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Beschreibung
Time of resolution or death
Datentyp
time
Maßeinheiten
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2699488
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2]
- C1301931
Beschreibung
Withdrawal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beschreibung
Relationship to Investigational Product(s)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3828190
Beschreibung
Definition of Seriousness
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704788
- UMLS CUI [1,2]
- C1710056
Beschreibung
check all that apply
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0015127
Beschreibung
Serious Adverse Event
Datentyp
text
Alias
- UMLS CUI [1]
- C1710056
Beschreibung
autopsy done
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Beschreibung
Medical conditions relevant to SAE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1519255
Beschreibung
Serious Adverse Event Onset Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Beschreibung
Current Condition while SAE
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3827351
- UMLS CUI [1,2]
- C1519255
Beschreibung
Current Condition while SAE
Datentyp
date
Alias
- UMLS CUI [1,1]
- C3827351
- UMLS CUI [1,2]
- C0011008
Beschreibung
Other relevant risk factors
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0035648
- UMLS CUI [1,2]
- C1519255
Beschreibung
Details of lnvestigational Product(s)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522508
Beschreibung
Details of lnvestigational Product(s)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522508
Beschreibung
Details of lnvestigational Product(s)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522508
Beschreibung
Details of lnvestigational Product(s)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522508
Beschreibung
Details of lnvestigational Product(s)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522508
Beschreibung
Details of lnvestigational Product(s)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522508
Beschreibung
Include any concomitant medications that may contribute to the occurrence of the SAE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519255
Beschreibung
Include any concomitant medications that may contribute to the occurrence of the SAE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519255
Beschreibung
Medication Dose
Datentyp
integer
Alias
- UMLS CUI [1]
- C3174092
Beschreibung
e.g.: G=Gram L=Litre MCG=Microgram MCL=Microlitre MG=Milligram ML=Millilitre TAB=Tablet
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Frequency
Datentyp
text
Alias
- UMLS CUI [1]
- C3476109
Beschreibung
Administration Route
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Medication Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826734
Beschreibung
Started Pre-Study
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0451613
Beschreibung
Medication End Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1521826
- UMLS CUI [1,2]
- C0806020
Beschreibung
Ongoing Medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Reason for Medication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826696
Beschreibung
Provide a textual description of the serious adverse event (including treatment of the event)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1519255
Beschreibung
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C1519255
Beschreibung
Reporting Investigator
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1533716
Beschreibung
Investigator Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Investigator Address
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Beschreibung
Investigator Signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Date of completion
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0850287
Beschreibung
Additional or follow-up information
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1533716
- UMLS CUI [1,2]
- C1519255
Beschreibung
Investigator Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Investigator Address
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Beschreibung
Investigator Signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Date of completion
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0850287
Ähnliche Modelle
Main CRF
- StudyEvent: ODM
C3274438 (UMLS CUI-2)
C0332170 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1705566 (UMLS CUI [1,2])
C1705566 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C3538994 (UMLS CUI-2)
C0332170 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1705566 (UMLS CUI [1,2])
C1705566 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C3538994 (UMLS CUI-2)
C0332170 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1705566 (UMLS CUI [1,2])
C1705566 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
C1705116 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1710477 (UMLS CUI [1,2])
C0451613 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0884980 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C2699488 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1301931 (UMLS CUI [2])
C1519255 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0451613 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1533716 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0850287 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0850287 (UMLS CUI [1,2])