ID
26096
Beschrijving
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.
Trefwoorden
Versies (1)
- 09-10-17 09-10-17 -
Houder van rechten
Glaxo Smith Kline
Geüploaded op
9 oktober 2017
DOI
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Licentie
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
Beschrijving
lnvestigational Product Treatment Period 1
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3538994
Beschrijving
Subject number
Datatype
integer
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
Morning Dose
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0332170
Beschrijving
Evening Dose
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0587117
Beschrijving
Compliance behavior
Datatype
text
Alias
- UMLS CUI [1]
- C1321605
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0011008
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0040223
Beschrijving
Number of Inhalations Accuhaler
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0001559
- UMLS CUI [1,2]
- C1705566
Beschrijving
Number of Inhalations BADPI
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0001559
- UMLS CUI [1,2]
- C1705566
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3845681
- UMLS CUI [1,2]
- C0304229
Beschrijving
Specify Changes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0443172
- UMLS CUI [1,2]
- C1521902
Beschrijving
lnvestigational Product Treatment Period 2
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C3538994
Beschrijving
Subject number
Datatype
integer
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
Morning Dose
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0332170
Beschrijving
Evening Dose
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0587117
Beschrijving
Compliance behavior
Datatype
text
Alias
- UMLS CUI [1]
- C1321605
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0011008
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0040223
Beschrijving
Number of Inhalations Accuhaler
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0001559
- UMLS CUI [1,2]
- C1705566
Beschrijving
Number of Inhalations BADPI
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0001559
- UMLS CUI [1,2]
- C1705566
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3845681
- UMLS CUI [1,2]
- C0304229
Beschrijving
Specify Changes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0443172
- UMLS CUI [1,2]
- C1521902
Beschrijving
Pharmacogenetic Research
Alias
- UMLS CUI-1
- C0031325
Beschrijving
Informed Consent
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
Beschrijving
Date informed consent obtained
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021430
Beschrijving
Informed consent refused
Datatype
text
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1705116
Beschrijving
Blood Sample Collection
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005834
Beschrijving
Date sample taken
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Withdrawal of Consent
Datatype
boolean
Alias
- UMLS CUI [1]
- C1707492
Beschrijving
Blood sample destruction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1948029
- UMLS CUI [1,2]
- C0178913
Beschrijving
Blood sample destruction reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C1948029
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C0392360
Beschrijving
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Concomitant medications during screening period
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1710477
Beschrijving
Drug Name
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Medication Dose
Datatype
float
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Units
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0013227
Beschrijving
e.g.: BID=2 x Daily OD=1 x Daily PRN=As required QID=4 x Daily TID=3 x Daily
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Concomitant Medication Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Started Pre-Study
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0451613
Beschrijving
Concomitant medication start time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C2347852
Beschrijving
Concomitant Medication Stop Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Ongoing Medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Concomitant medication end time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C2347852
Beschrijving
Condition treated/Indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C2347852
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1]
- C2981656
Beschrijving
Rescue Medication
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0884980
Beschrijving
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C0877248
Beschrijving
If YES, indicate below
Datatype
boolean
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Diagnosis only (if known) or signs / symptoms (list one per line)
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0574845
Beschrijving
00:00-23 59
Datatype
time
Alias
- UMLS CUI [1]
- C0449244
Beschrijving
Maximum Intensity
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Beschrijving
Outcome
Datatype
text
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C2985918
Beschrijving
Time of resolution
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1]
- C2826658
Beschrijving
Action taken with investigational product
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Beschrijving
Withdrawal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0877248
Beschrijving
Relationship to Investigational Product
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0015127
Beschrijving
Seriousness
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1518404
Beschrijving
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Investigator Identifier
Datatype
integer
Alias
- UMLS CUI [1]
- C2826689
Beschrijving
Treatment Number
Datatype
text
Alias
- UMLS CUI [1]
- C1522541
Beschrijving
Subject number
Datatype
integer
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
Serious Adverse Events
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Gender
Datatype
integer
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Race
Datatype
integer
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Serious Adverse Events
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Serious Adverse Event Onset Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2985916
- UMLS CUI [1,2]
- C1519255
Beschrijving
SAE onset time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449244
Beschrijving
Maximum Intensity
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Beschrijving
Outcome SAE
Datatype
text
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
Date of resolution or death
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Beschrijving
Time of resolution or death
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2699488
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2]
- C1301931
Beschrijving
Withdrawal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beschrijving
Relationship to Investigational Product(s)
Datatype
boolean
Alias
- UMLS CUI [1]
- C3828190
Beschrijving
Definition of Seriousness
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704788
- UMLS CUI [1,2]
- C1710056
Beschrijving
check all that apply
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0015127
Beschrijving
Serious Adverse Event
Datatype
text
Alias
- UMLS CUI [1]
- C1710056
Beschrijving
autopsy done
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Beschrijving
Medical conditions relevant to SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1519255
Beschrijving
Serious Adverse Event Onset Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Beschrijving
Current Condition while SAE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3827351
- UMLS CUI [1,2]
- C1519255
Beschrijving
Current Condition while SAE
Datatype
date
Alias
- UMLS CUI [1,1]
- C3827351
- UMLS CUI [1,2]
- C0011008
Beschrijving
Other relevant risk factors
Datatype
text
Alias
- UMLS CUI [1,1]
- C0035648
- UMLS CUI [1,2]
- C1519255
Beschrijving
Details of lnvestigational Product(s)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522508
Beschrijving
Details of lnvestigational Product(s)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522508
Beschrijving
Details of lnvestigational Product(s)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522508
Beschrijving
Details of lnvestigational Product(s)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522508
Beschrijving
Details of lnvestigational Product(s)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522508
Beschrijving
Details of lnvestigational Product(s)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522508
Beschrijving
Include any concomitant medications that may contribute to the occurrence of the SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519255
Beschrijving
Include any concomitant medications that may contribute to the occurrence of the SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519255
Beschrijving
Medication Dose
Datatype
integer
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
e.g.: G=Gram L=Litre MCG=Microgram MCL=Microlitre MG=Milligram ML=Millilitre TAB=Tablet
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Administration Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Medication Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Started Pre-Study
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0451613
Beschrijving
Medication End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1521826
- UMLS CUI [1,2]
- C0806020
Beschrijving
Ongoing Medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Reason for Medication
Datatype
text
Alias
- UMLS CUI [1]
- C2826696
Beschrijving
Provide a textual description of the serious adverse event (including treatment of the event)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1519255
Beschrijving
Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C1519255
Beschrijving
Reporting Investigator
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1533716
Beschrijving
Investigator Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Investigator Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Beschrijving
Investigator Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Date of completion
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0850287
Beschrijving
Additional or follow-up information
Datatype
text
Alias
- UMLS CUI [1,1]
- C1533716
- UMLS CUI [1,2]
- C1519255
Beschrijving
Investigator Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Investigator Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Beschrijving
Investigator Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Date of completion
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0850287
Similar models
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])