Age | Childbearing Potential
Item
male or female subjects aged ≥18 years. females may be of either childbearing or non-childbearing potential
boolean
C0001779 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
Asthma
Item
physician diagnosed history of asthma for at least 12 weeks prior to screening
boolean
C0004096 (UMLS CUI [1])
FEV1 pre bronchodilator
Item
pre-bronchodilator fev1 60-85% at screening and other specified visits
boolean
C0748133 (UMLS CUI [1,1])
C2599602 (UMLS CUI [1,2])
post bronchodilator disease reversibility
Item
post-bronchodilator reversibility >/=12%
boolean
C2599594 (UMLS CUI [1,1])
C0679253 (UMLS CUI [1,2])
Non-smoker | Former smoker | smoking cigarettes: ____ pack-years history
Item
non-smokers and prior smokers with no history of smoking within the past 12 months prior to screening and a total smoking history of ≤10 pack-years
boolean
C0337672 (UMLS CUI [1])
C0337671 (UMLS CUI [2])
C2230126 (UMLS CUI [3])
Ability Medication stopped Asthma | Albuterol
Item
subjects able to discontinue asthma medications for the duration of the study and be maintained using albuterol as required
boolean
C0085732 (UMLS CUI [1,1])
C1273478 (UMLS CUI [1,2])
C0004096 (UMLS CUI [1,3])
C0001927 (UMLS CUI [2])
Body mass index
Item
body mass index between 18-40 kg/m2 inclusive
boolean
C1305855 (UMLS CUI [1])
Exclusion Criteria
Item
key exclusion criteria include:
boolean
C0680251 (UMLS CUI [1])
Comorbidity | Diabetes Mellitus, Insulin-Dependent Poorly controlled | Diabetes Mellitus, Non-Insulin-Dependent Poorly controlled | Epilepsy | Cerebrovascular accident | Abnormal cardiac conduction
Item
presence or recent history of any other active, severe, progressive, and/or uncontrolled clinical disease, eg, poorly controlled type 1 or 2 diabetes, seizure disorder or epilepsy, cerebrovascular accident, significant cardiac conduction abnormalities
boolean
C0009488 (UMLS CUI [1])
C0011854 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0011860 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C0014544 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0232219 (UMLS CUI [6])
Respiration Disorders | Asthma | Allergic rhinitis | Nasal Polyps | Chronic sinusitis | Chronic Obstructive Airway Disease | Bronchiectasis | Churg-Strauss Syndrome | Lung excision | Pulmonary Fibrosis | Pulmonary Hypertension | Cystic Fibrosis | Sarcoidosis
Item
respiratory conditions other than asthma and allergic rhinitis, including but not limited to: severe nasal polyposis or chronic rhinosinusitis, chronic obstructive pulmonary disease, bronchiectasis, churg-strauss disease, lung resection, pulmonary fibrosis (primary or secondary), pulmonary hypertension, cystic fibrosis, sarcoidosis
boolean
C0035204 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C2607914 (UMLS CUI [3])
C0027430 (UMLS CUI [4])
C0149516 (UMLS CUI [5])
C0024117 (UMLS CUI [6])
C0006267 (UMLS CUI [7])
C0008728 (UMLS CUI [8])
C0396565 (UMLS CUI [9])
C0034069 (UMLS CUI [10])
C0020542 (UMLS CUI [11])
C0010674 (UMLS CUI [12])
C0036202 (UMLS CUI [13])
Asthma Life Threatening | Episode of Asthma | Intubation | Hypercapnia | Respiratory arrest | Hypoxic convulsions | Syncopal Episode Asthma
Item
history of life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s)
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0332189 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0021925 (UMLS CUI [3])
C0020440 (UMLS CUI [4])
C0162297 (UMLS CUI [5])
C1843573 (UMLS CUI [6])
C0751534 (UMLS CUI [7,1])
C0004096 (UMLS CUI [7,2])
Exacerbation of asthma | Hospitalization | Emergency room admission
Item
in patient hospitalization (not including er visits) for an asthma exacerbation within the past year or during the run in period
boolean
C0349790 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
C0583237 (UMLS CUI [3])
Exacerbation of asthma | Therapy change | Adrenal Cortex Hormones | Intravenous steroid injection
Item
an asthma exacerbation requiring change in asthma therapy or oral/iv corticosteroids in the 3 months prior to screening
boolean
C0349790 (UMLS CUI [1])
C3665894 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
C0563322 (UMLS CUI [4])
Unstable status Asthma Seasonal asthma | Study Subject Participation Status
Item
history of seasonally unstable asthma where the season will coincide with the subject's participation in the study
boolean
C0443343 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C2919352 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2])
Pharmaceutical Preparations | Adrenergic beta-Antagonists | Tricyclic Antidepressive Agents | Decongestants | Benzodiazepines | Digitalis preparation | Phenothiazines | Monoamine Oxidase Inhibitors
Item
use of prescription or non-prescription drugs, including beta blockers, tricyclic antidepressants, oral decongestants, benzodiazepines, digitalis, phenothiazines, monoamine oxidase inhibitors, etc
boolean
C0013227 (UMLS CUI [1])
C0001645 (UMLS CUI [2])
C0003290 (UMLS CUI [3])
C0282374 (UMLS CUI [4])
C0005064 (UMLS CUI [5])
C0304520 (UMLS CUI [6])
C0031436 (UMLS CUI [7])
C0026457 (UMLS CUI [8])
Hypersensitivity Investigational New Drugs | Hypersensitivity Lactose | Hypersensitivity Milk Proteins
Item
suspected hypersensitivity to the study drugs (including lactose) or severe milk protein allergy
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0022949 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0026138 (UMLS CUI [3,2])
ECG abnormality
Item
clinically significant abnormalities in the screening ecg
boolean
C0522055 (UMLS CUI [1])
Substance Use Disorders | Substance Dependence
Item
evidence of alcohol or drug abuse or dependency within 6 months prior to screening
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])