Item
Did the subject meet all the randomisation criteria?
text
C0034656 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Code List
Did the subject meet all the randomisation criteria?
baseline dysnpnoea index
Item
Achieves a BDI focal score of ≤ 7 units at Visit 2
boolean
C1511069 (UMLS CUI [1])
visual analog scale of COPD symptoms
Item
Achieves a composite VAS score of ≥120 (out of 400 maximum) on 4 or more days over the 7 days immediately prior to Visit 2.
boolean
C3536884 (UMLS CUI [1,1])
C1737716 (UMLS CUI [1,2])
ability of daily documentation
Item
Is able to complete a Daily Record Card.
boolean
C0920316 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
ability to show the correct inhaler technique
Item
Is able to demonstrate correct use of DISKUS/ACCUHALER.
boolean
C0419833 (UMLS CUI [1])
incomplete documentation of the daily record card
Item
Has less than 4 consecutive days with complete run-in DRC data within the 7 consecutive days prior to Visit 2.
boolean
C3845717 (UMLS CUI [1])
abnormal clinical haematology and chemistry or cortisol level
Item
Has (in the opinion of the investigator) a clinically significant abnormal clinical haematology and chemistry or cortisol value at Visit 1.
boolean
C1332129 (UMLS CUI [1])
C0428396 (UMLS CUI [2])
COPD exacerbation
Item
Has experienced a moderate or severe exacerbation of their COPD during the Run-In period.
boolean
C0740304 (UMLS CUI [1])
change in COPD medication or medication other than the permitted
Item
Subjects who have had a change to their COPD medication or taken non-permitted medications, other than "as required" use of VENTOLIN for the management of COPD exacerbations between Visits 1 and 2.
boolean
C0024117 (UMLS CUI [1,1])
C0580105 (UMLS CUI [1,2])
C1115771 (UMLS CUI [2])