Asthma
Item
diagnosis of asthma as defined by global initiative for asthma (gina) 2011
boolean
C0004096 (UMLS CUI [1])
Therapeutic procedure Inhaled steroids | Budesonide | Adrenergic beta-2 Receptor Agonists
Item
asthmatic patients already treated with low daily doses of inhaled corticosteroids (ics) (eg budesonide or equivalent lower than 400 mcg/day) or low dose of ics/long acting beta2 agonists (laba) fixed combinations.
boolean
C0087111 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])
C0054201 (UMLS CUI [2])
C2936789 (UMLS CUI [3])
FEV1
Item
patients with forced expiratory volume in 1 sec (fev1) >= 70 % of predicted values
boolean
C0748133 (UMLS CUI [1])
Non-smoker | Former smoker
Item
non or ex-smokers
boolean
C0337672 (UMLS CUI [1])
C0337671 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) >= 18.5 and <= 32 kg/m2
boolean
C1305855 (UMLS CUI [1])
Pregnancy | Breast Feeding | Contraceptive methods
Item
pregnant or lactating women unless using acceptable methods of contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Chronic Obstructive Airway Disease
Item
diagnosis of chronic obstructive pulmonary disease (copd)
boolean
C0024117 (UMLS CUI [1])
Asthma Near Fatal
Item
history of near fatal asthma
boolean
C0004096 (UMLS CUI [1,1])
C1706276 (UMLS CUI [1,2])
C1302234 (UMLS CUI [1,3])
QTcF Abnormal
Item
patients with abnormal qtcf at screening visit
boolean
C1882513 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Exacerbation of asthma | Hospitalization
Item
hospitalization due to asthma exacerbation within 4 weeks prior to the screening visit or during the run-in period.
boolean
C0349790 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
Lower respiratory tract infection
Item
lower respiratory tract infection within 4 weeks prior to the screening visit or during the run-in period.
boolean
C0149725 (UMLS CUI [1])
Substance abuse
Item
history of drug addiction or excessive use of alcohol ;
boolean
C0740858 (UMLS CUI [1])
Restrictive lung disease
Item
diagnosis of restrictive lung disease.
boolean
C0085581 (UMLS CUI [1])
Oral steroid therapy | Parenteral steroid treatment | Parenteral Adrenal Cortex Hormones Depot Preparations
Item
patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids)
boolean
C0574135 (UMLS CUI [1])
C3840673 (UMLS CUI [2])
C1518896 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
C0086129 (UMLS CUI [3,3])
Significant Medical History | Laboratory test result abnormal
Item
significant medical history or any laboratory abnormality indicative of a significant underlying condition
boolean
C0750502 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2])