age informed consent
Item
male and female adult patients aged 18-75 years (inclusive), who have signed an informed consent form prior to initiation of any study-related procedure,
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
persistent asthma
Item
patients with persistent asthma, diagnosed according to global initiative for asthma (gina) guidelines (national institute of health, national heart, lung and blood institute, 2006) and who additionally meet the following criteria:
boolean
C3266628 (UMLS CUI [1])
inhaled corticosteroid
Item
patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the product label, in a stable regimen for the month prior to visit 1.
boolean
C0586793 (UMLS CUI [1])
fev1
Item
patients with an fev1 at visit 1 ≥50% of predicted normal.
boolean
C0748133 (UMLS CUI [1])
fev1 post-bronchodilator
Item
patients who demonstrate an increase of ≥ 12% and ≥ 200 ml in fev1 over their pre-bronchodilator.
boolean
C0748133 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
pregnancy lactation childbearing potential contraception
Item
pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
smoking history
Item
patients who have used tobacco products within the 6 months period prior to visit 1, or who have a smoking history of greater than 10 pack years.
boolean
C1519384 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
copd
Item
patients diagnosed with chronic obstructive pulmonary disease (copd) as defined by the gold guidelines (global initiative for chronic obstructive lung disease 2006).
boolean
C0024117 (UMLS CUI [1])
seasonal allergy worsening asthma
Item
patients with seasonal allergy whose asthma is likely to deteriorate during the study period.
boolean
C0018621 (UMLS CUI [1])
C0004096 (UMLS CUI [2,1])
C1457868 (UMLS CUI [2,2])
asthma exacerbation requiring hospitalization
Item
patients who have had an acute asthma attack/exacerbation requiring hospitalization in the 6 months prior to visit 1.
boolean
C0349790 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
asthma exacerbation requiring emergency room visit
Item
patients who have had an acute asthma attack / exacerbation requiring an emergency room visit within 6 weeks prior to visit 1 or at any time between visit 1 and visit 2.
boolean
C0349790 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0583237 (UMLS CUI [1,3])
respiratory tract infection
Item
patients who have had a respiratory tract infection within 4 weeks prior to visit 1 or at any time between visit 1 and visit 2.
boolean
C0035243 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
long qt syndrome or long qtc
Item
patients with a history of long qt interval syndrome or whose qt interval corrected for heart rate (qtc) interval (bazett's) measured at visit 1 or visit 2 is prolonged: > 450 ms (males) or > 470 ms (females).
boolean
C0023976 (UMLS CUI [1])
C0151878 (UMLS CUI [2])
comorbidity limiting study protocol
Item
other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
criteria
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C0242801 (UMLS CUI [1])