Age | Healthy Volunteers | Asthma | Non-smoker | Smoker | Chronic Obstructive Airway Disease
Item
age: for part 1, healthy: 18 and 55 years; for part 1, asthma: 18 and 70 years; for part 2, nonsmokers: 40 and 65 years; for part 2, smokers: 40 and 65 years; for part 2, chronic obstructive pulmonary disease (copd): 40 and 65 years
boolean
C0001779 (UMLS CUI [1])
C1708335 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
C0337672 (UMLS CUI [4])
C0337664 (UMLS CUI [5])
C0024117 (UMLS CUI [6])
Mild asthma | Moderate asthma | Severe asthma
Item
having mild, moderate, or severe asthma (for part 1, asthma)
boolean
C0581124 (UMLS CUI [1])
C0581125 (UMLS CUI [2])
C0581126 (UMLS CUI [3])
Asthma Stable status | control Therapeutic procedure
Item
clinically stable asthma and have been on their current asthma controller therapy for at least 6 weeks prior to screening (for part 1, asthma)
boolean
C0004096 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0243148 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Chronic disease of respiratory system | Asthma | Non-smoker
Item
no history of chronic respiratory disease including asthma (for part 2, nonsmokers)
boolean
C0264220 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0337672 (UMLS CUI [3])
Non-smoker | smoking cigarettes: ____ pack-years history
Item
be a nonsmoker for 1 year or more at initial screening visit and have 10 packs or less per year history of smoking (for all part 1 and pat 2, nonsmokers)
boolean
C0337672 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
Current Smoker | smoking cigarettes: ____ pack-years history
Item
be a current smoker with a current history of at least 20 pack years (for part 2, smokers)
boolean
C3241966 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
Chronic Obstructive Airway Disease Stable status
Item
stable copd in the 3 months prior to screening (for part 2, copd)
boolean
C0024117 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Adrenergic beta-Agonists | BRONCHODILATORS,ANTICHOLINERGIC | inhaled steroids
Item
treating with beta-adrenergic receptor agonist, anticholinergic bronchodilators, inhaled corticosteroid at stable doses for at least 4 weeks prior to screening (for part 2, copd)
boolean
C0001644 (UMLS CUI [1])
C0354764 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
Sleep Apnea Syndromes | Medical Intervention regimes | Urine pregnancy test positive
Item
history of sleep apnea requiring medical intervention and positive urine pregnancy screening result (for all part 1 and part 2)
boolean
C0037315 (UMLS CUI [1])
C0205476 (UMLS CUI [2,1])
C1273869 (UMLS CUI [2,2])
C0430059 (UMLS CUI [3])
Urine screening Nicotine Positive | HIV Seropositivity HIV Antibodies | Hepatitis B Surface Antigens | Hepatitis C Antibodies
Item
positive urine screen for nicotine; positive serology test for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen, or hepatitis c virus antibody at screening (for all part 1 and part 2)
boolean
C0595946 (UMLS CUI [1,1])
C0028040 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
C0019699 (UMLS CUI [2,1])
C0019683 (UMLS CUI [2,2])
C0019168 (UMLS CUI [3])
C0166049 (UMLS CUI [4])
Aspergillosis, Allergic Bronchopulmonary | Allergic Bronchopulmonary Mycosis | Asthma, Occupational
Item
allergic bronchopulmonary aspergillosis, allergic bronchopulmonary mycosis, or occupational asthma (for part 1, asthma)
boolean
C0004031 (UMLS CUI [1])
C2931854 (UMLS CUI [2])
C0264423 (UMLS CUI [3])
Long-term oxygen therapy Chronic hypoxemia
Item
requires long term oxygen therapy on a daily basis for chronic hypoxemia at screening visit except when used for exercise only (for part 2, copd)
boolean
C0418996 (UMLS CUI [1,1])
C0745188 (UMLS CUI [1,2])
Pneumonia | COPD exacerbation | systemic steroids | Upper Respiratory Infections | Lower respiratory tract infection | Malignant neoplasm of lung Surgery specialty | Lung Volume Reduction | Lung Transplantation
Item
pneumonia, copd exacerbation that required systemic steroids, upper or lower respiratory tract infection, lung cancer surgery, lung volume reduction, or a lung transplant (for part 2, copd)
boolean
C0032285 (UMLS CUI [1])
C0740304 (UMLS CUI [2])
C2825233 (UMLS CUI [3])
C0041912 (UMLS CUI [4])
C0149725 (UMLS CUI [5])
C0242379 (UMLS CUI [6,1])
C0038894 (UMLS CUI [6,2])
C0524689 (UMLS CUI [7])
C0024128 (UMLS CUI [8])