Age | Moderate persistent allergic asthma | Severe persistent allergic asthma | Inhaled corticosteroids | beta-Agonists
Item
patients 18-75 years of age with moderate to severe persistent allergic asthma receiving a high dose inhaled corticosteroid (≥800µg per day bdp or equivalent) and a regular long acting beta-agonist for at least 3 months prior to screening
boolean
C0001779 (UMLS CUI [1,1])
C4039651 (UMLS CUI [1,2])
C4041248 (UMLS CUI [1,3])
C3248292 (UMLS CUI [1,4])
C0001644 (UMLS CUI [1,5])
Body weight | serum IgE measurement
Item
with a body weight between 20 and 150kg and a serum total ige level of 30 to 700 iu/ml
boolean
C0005910 (UMLS CUI [1,1])
C2229760 (UMLS CUI [1,2])
Eosinophilia | Sputum, Induced
Item
with ≥2 percent eosinophilia in induced sputum at screening
boolean
C0014457 (UMLS CUI [1,1])
C3179346 (UMLS CUI [1,2])
FEV1 | post bronchodilator
Item
with post-bronchodilator forced expiratory volume in 1 second (fev1) ≥60 percent predicted
boolean
C0748133 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
Skin prick test | Radioallergosorbent Test | Aeroallergen
Item
with a positive skin prick test (diameter of wheal ≥ 3 mm) or rast test to at least one perennial aero-allergen (eg. dust mite, cat/dog dander, cockroaches), documented within the past 2 years or demonstrated at visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
boolean
C0034554 (UMLS CUI [1])
C0430561 (UMLS CUI [2,1])
C3827475 (UMLS CUI [2,2])
C0001697 (UMLS CUI [2,3])
C1275706 (UMLS CUI [2,4])
C0440456 (UMLS CUI [3])
C0440458 (UMLS CUI [4])
C0009208 (UMLS CUI [5])
Asthma exacerbation
Item
patients who've had an asthma exacerbation during the 4 weeks prior to randomization
boolean
C0349790 (UMLS CUI [1])
Current smoker | Stopped smoking
Item
current smokers, stopped smoking within the last 12 months or have a smoking history of >10 pack years
boolean
C3241966 (UMLS CUI [1,1])
C0425310 (UMLS CUI [1,2])
C2230126 (UMLS CUI [1,3])
Food allergy | Drug allergy
Item
history of severe allergy to food or drugs
boolean
C0016470 (UMLS CUI [1])
C0013182 (UMLS CUI [2])
Omalizumab | Prior therapy
Item
previous treatment with omalizumab
boolean
C0966225 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Bronchoscopy | Patient unsuitable for procedure
Item
any patient considered to be unsuitable to bronchoscopy, according to the judgment of the investigator
boolean
C0006290 (UMLS CUI [1,1])
C3839996 (UMLS CUI [1,2])
Inclusion criteria | Exclusion criteria
Item
other protocol-defined inclusion/exclusion criteria applied.
boolean
C1704756 (UMLS CUI [1])