moderate to severe persistent asthma
Item
clinical diagnosis of moderate to severe persistent asthma (according to gina 2002 guidelines)
boolean
C1960047 (UMLS CUI [1])
C1960048 (UMLS CUI [2])
post-bronchodilator fev1
Item
fev1 > 40% and < 80% of predicted normal post-bronchodilator (and at least 0.7 l absolute value)
boolean
C0748133 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
inhaled corticosteroids plus laba
Item
patients already treated for at least 2 months with an association of inhaled corticosteroids plus laba at doses of:
boolean
C2065041 (UMLS CUI [1])
C1373132 (UMLS CUI [2])
beclomethasone dipropionate formoterol salmeterol
Item
750 - 1000 µg beclomethasone dipropionate or equivalent (icss) 24 µg formoterol or 100 µg salmeterol (labas)
boolean
C0004906 (UMLS CUI [1])
C0060657 (UMLS CUI [2])
C0073992 (UMLS CUI [3])
naive of laba inhaled corticosteroids
Item
or patients naïve of laba already treated for at least 2 months with inhaled corticosteroids (doses as above) associated with a daily use of saba and/or with clinical symptoms > 3 times in the week prior to inclusion
boolean
C0919936 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
reversibility test
Item
a documented positive response to the reversibility test.
boolean
C1272658 (UMLS CUI [1])
pregnancy or lactation
Item
pregnant or lactating females or women of childbearing potential without any efficient contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
smoking history
Item
heavy smokers defined as smoking for > 10 pack years.
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
asthma exacerbation
Item
evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids).
boolean
C0349790 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C4039704 (UMLS CUI [2])
C0019993 (UMLS CUI [3])
C0035243 (UMLS CUI [4,1])
C0040223 (UMLS CUI [4,2])
seasonal asthma or allergic asthma
Item
seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer.
boolean
C2919352 (UMLS CUI [1])
C0155877 (UMLS CUI [2])
comorbidity
Item
clinically significant or unstable concomitant diseases, including clinically significant laboratory abnormalities.
boolean
C0009488 (UMLS CUI [1])
qtc interval
Item
patients with an abnormal qtc interval value in the ecg test, defined as > 450 msec in males or > 470 msec in females.
boolean
C0489625 (UMLS CUI [1])
asthma worsening
Item
evidence of asthma worsening during the week preceding randomisation (e.g. pef variability > 30% during 2 consecutive days, saba use > 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days
boolean
C0004096 (UMLS CUI [1,1])
C1457868 (UMLS CUI [1,2])