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