persistent asthma
Item
a history of persistent asthma for at least the 4 months prior to entry
boolean
C3266628 (UMLS CUI [1])
inhaled corticosteroids and saba
Item
require daily inhaled corticosteroids (220-1000 µg fluticasone equivalent per day) for at least 4 weeks prior to randomization and short-acting beta-2-agonist (saba)
boolean
C2065041 (UMLS CUI [1])
C2917450 (UMLS CUI [2])
fev1
Item
fev1 at randomization (without exposure to a saba for at least 6 hours) must be between 50% and 80% of predicted normal
boolean
C0748133 (UMLS CUI [1])
reversibility of fev1
Item
reversibility of fev1 by at least 12% and at least 250 ml following two to four inhalations of a saba must be demonstrated prior to randomization
boolean
C0748133 (UMLS CUI [1,1])
C0679253 (UMLS CUI [1,2])
C2917450 (UMLS CUI [1,3])
AQLQ
Item
aqlq(s) score of 4.5 or less at both the screening (visit 1) and randomization (visit 2) visits
boolean
C2919855 (UMLS CUI [1])
criteria
Item
patients must meet at least two out of three of the following criteria:
boolean
C1512693 (UMLS CUI [1])
asthma control questionnaire
Item
overall score minimum of 2 on asthma control questionnaire (acq)
boolean
C2919686 (UMLS CUI [1])
saba use
Item
require rescue saba use of 2 or more inhalations per day for symptom relief on at least 4 of 7 days during each week of the baseline period
boolean
C1373132 (UMLS CUI [1])
nighttime awakenings due to asthma
Item
nighttime awakenings due to asthma, an average of at least once a week during the baseline period
boolean
C1273489 (UMLS CUI [1])
copd or other relevant lung diseases
Item
history of chronic pulmonary diseases other than asthma, including bronchitis, chronic obstructive pulmonary disease (copd), emphysema, cystic fibrosis, pulmonary tuberculosis, or bronchiectasis
boolean
C0024117 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
asthma therapy
Item
other asthma therapies:
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
beta-2 agonists
Item
use of long-acting beta-2-agonists within 5 weeks prior to randomization
boolean
C1373132 (UMLS CUI [1])
leukotriene, theophylline, or muscarinic antagonists
Item
use of leukotriene modulators, theophylline, or muscarinic antagonists within 4 weeks prior to randomization
boolean
C3542962 (UMLS CUI [1])
C0039771 (UMLS CUI [2])
C0003385 (UMLS CUI [3])
corticosteroids
Item
use of injectable or oral corticosteroids within 2 months prior to screening
boolean
C0001617 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
beta 2 agonist frequency
Item
requirement for more than 10 inhalations per day of a short-acting beta-2-agonist more than 3 times per week during the baseline period
boolean
C2936789 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])