Mild to severe COPD
Item
Does the participant have mild to severe COPD: Ratio of forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) less than or equal to 0.70, FEV1 20-80% of predicted?
boolean
C2945599 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
C0205082 (UMLS CUI [2,1])
C0024117 (UMLS CUI [2,2])
C0438193 (UMLS CUI [3])
C0860907 (UMLS CUI [4])
Current or former smoker
Item
Is the participant a current or former smoker?
boolean
C3241966 (UMLS CUI [1])
C0337671 (UMLS CUI [2])
HRCT scan
Item
Does the participant have a HRCT scan with 5-35% of voxels with density less than -950 Hounsfield Units (HU)?
boolean
C0412612 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C2700259 (UMLS CUI [1,3])
C0178587 (UMLS CUI [1,4])
C0205251 (UMLS CUI [1,5])
Informed consent
Item
Does the participant have the ability to understand and willingness to sign consent documents?
boolean
C1273101 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
C0600109 (UMLS CUI [2,1])
C1519316 (UMLS CUI [2,2])
C0009797 (UMLS CUI [2,3])
ACE or ARB therapy
Item
Does the participant have current therapy with angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB)?
boolean
C2827774 (UMLS CUI [1,1])
C0003015 (UMLS CUI [1,2])
C2827774 (UMLS CUI [2,1])
C0521942 (UMLS CUI [2,2])
ACE inhibitor or ARB intolerance
Item
Does the participant have a known intolerance to ACE inhibitor or ARB?
boolean
C1744706 (UMLS CUI [1,1])
C0003015 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0521942 (UMLS CUI [2,2])
History of angioedema
Item
Does the participant have a history of angioedema?
boolean
C0262926 (UMLS CUI [1,1])
C0002994 (UMLS CUI [1,2])
Conventional indication for ACE inhibitor or ARB
Item
Does the participant have a conventional indication for ACE inhibitor or ARB (e.g., history of myocardial infarction, known cardiomyopathy)?
boolean
C0439858 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0003015 (UMLS CUI [1,3])
C0439858 (UMLS CUI [2,1])
C3146298 (UMLS CUI [2,2])
C0521942 (UMLS CUI [2,3])
Renal insufficiency
Item
Does the participant have renal insufficiency (GFR <30 mL/min by Cockcroft-Gault calculation)?
boolean
C1565489 (UMLS CUI [1])
C4544895 (UMLS CUI [2])
Current regular NSAID use
Item
Does the participant have current regular use of NSAIDs defined as daily use 5 or more days of the week for more than one month?
boolean
C0521116 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0003211 (UMLS CUI [1,3])
Potassium supplementation or serum potassium level
Item
Does the participant have a potassium supplementation or serum potassium level of 5.0 milliequivalents (mEq)/dL or higher at V1?
boolean
C0561938 (UMLS CUI [1])
C0302353 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Current potassium sparing diuretic
Item
Does the participant have a current use of a potassium sparing diuretic?
boolean
C0521116 (UMLS CUI [1,1])
C0304490 (UMLS CUI [1,2])
COPD exacerbation
Item
Does the participant have a COPD exacerbation requiring treatment within 6 weeks at V1?
boolean
C0740304 (UMLS CUI [1,1])
C0027552 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
Chronic systemic corticosteroid use
Item
Does the participant have a chronic systemic corticosteroid use of more than 10mg/day of prednisone?
boolean
C0205191 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0239126 (UMLS CUI [1,3])
Resting SpO2
Item
Does the participant have a resting SpO2 <89% on 2 L nasal cannula continuous flow; unless at altitude > 4,000 feet, then resting oxygen saturation (SpO2) <89% on 4 L N C continuous flow?
boolean
C4699029 (UMLS CUI [1,1])
C0428179 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C2016156 (UMLS CUI [1,4])
C4531406 (UMLS CUI [1,5])
C0238617 (UMLS CUI [2,1])
C4699029 (UMLS CUI [2,2])
C0428179 (UMLS CUI [2,3])
C0205251 (UMLS CUI [2,4])
C2016156 (UMLS CUI [2,5])
C0205250 (UMLS CUI [2,6])
C4531406 (UMLS CUI [2,7])
Untreated arterial hypertension
Item
Does the participant have untreated arterial hypertension (systolic blood pressure greater than140 mm Hg, diastolic blood pressure greater than 90 mm Hg)?
boolean
C0745134 (UMLS CUI [1])
C0277884 (UMLS CUI [2])
C0277889 (UMLS CUI [3])
Low blood pressure
Item
Does the participant have blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic while standing or sitting?
boolean
C0231472 (UMLS CUI [1,1])
C0277885 (UMLS CUI [1,2])
C0231472 (UMLS CUI [2,1])
C0277890 (UMLS CUI [2,2])
C0277814 (UMLS CUI [3,1])
C0277885 (UMLS CUI [3,2])
C0277814 (UMLS CUI [4,1])
C0277890 (UMLS CUI [4,2])
Unilateral/Bilateral renal artery stenosis
Item
Does the participant have known unilateral or bilateral renal artery stenosis higher than 70%?
boolean
C0205309 (UMLS CUI [1,1])
C0856759 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0205309 (UMLS CUI [2,1])
C0856760 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
Previous lung resection surgery
Item
Does the participant have a previous lung resection surgery?
boolean
C0205156 (UMLS CUI [1,1])
C0396565 (UMLS CUI [1,2])
Infectious lung disease
Item
Does the participant have evidence of interstitial, occupational or chronic infectious lung disease?
boolean
C0332120 (UMLS CUI [1,1])
C0596790 (UMLS CUI [1,2])
C0876973 (UMLS CUI [1,3])
C0332120 (UMLS CUI [2,1])
C0521127 (UMLS CUI [2,2])
C0876973 (UMLS CUI [2,3])
C0332120 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0876973 (UMLS CUI [3,3])
Changes to chest precluding HRCT
Item
Does the participant have changes to chest that preclude adequate HRCT imaging (e.g. Metallic objects in the chest such as shrapnel or pacemaker leads)?
boolean
C0392747 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
C4743675 (UMLS CUI [1,3])
C0412612 (UMLS CUI [1,4])
C2826620 (UMLS CUI [2])
C0522670 (UMLS CUI [3])
C1283151 (UMLS CUI [4])
Pregnancy test, birth control or abstinence
Item
Does the participant have a positive pregnancy test or unwillingness to use two methods of birth control or abstinence for the duration of the study?
boolean
C0240802 (UMLS CUI [1])
C0558080 (UMLS CUI [2,1])
C0004764 (UMLS CUI [2,2])
C0489652 (UMLS CUI [2,3])
C0558080 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C0489652 (UMLS CUI [3,3])
Major chronic illnesses
Item
Does the participant have a major chronic illnesses which in the judgment of the study physician would interfere with participation in the study e.g. including but not limited to: cardiac, renal, hepatic (LFTs more than 2.5x normal upper limit), neurological, psychiatric, endocrine or neoplastic diseases, uncontrolled diabetes, uncontrolled HIV infection or other immune system disorder, hyperthyroidism, seizure disorders, non-skin cancer, rheumatic diseases?
boolean
C0008679 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0018799 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C1882062 (UMLS CUI [8])
C2733146 (UMLS CUI [9])
C2732402 (UMLS CUI [10])
C0019693 (UMLS CUI [11,1])
C0205318 (UMLS CUI [11,2])
C1532237 (UMLS CUI [12])
C0020550 (UMLS CUI [13])
C0014544 (UMLS CUI [14])
C0006826 (UMLS CUI [15,1])
C4723751 (UMLS CUI [15,2])
C1123023 (UMLS CUI [15,3])
C3495832 (UMLS CUI [16])
Non-adherence
Item
Does the participant have a failure to keep screening appointments or other indicators of non-adherence?
boolean
C0680095 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1710032 (UMLS CUI [1,3])
C0021212 (UMLS CUI [2,1])
C0457432 (UMLS CUI [2,2])
No telephone contact
Item
Does the participant have an inability to be contacted by telephone?
boolean
C1299582 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0039457 (UMLS CUI [1,3])
Intention to leave area soon
Item
Does the participant have the intention to leave area within 12 months?
boolean
C1283828 (UMLS CUI [1,1])
C1706081 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C4018905 (UMLS CUI [1,4])