ID

38047

Description

A randomized, parallel, placebo controlled trial to evaluate the effect of 100mg/day losartan on the progression of emphysema as measured by quantitative HRCT compared to placebo. This is a trial designed to test if a treatment, losartan, may decrease the progression of Chronic Obstructive Pulmonary Disease (COPD). Losartan is an angiotensin receptor blocking agent, commonly used as an antihypertensive agent, which has been shown to alter cardiac remodeling after myocardial infarction and renovascular remodeling in diabetes-mellitus. In this trial participants with mild to severe COPD, with Computed Tomography (CT) evidence of emphysema (5-35% of voxels with < -950 Hounsfield Units), will be randomly assigned to receive 100mg/day of losartan or placebo for 48 weeks. The primary outcome measure will be the rate of progression of emphysema, quantified as the percent of lung voxels with a density less than -950 HU as measured by High Resolution CT (HRCT, from baseline to 48 weeks.

Mots-clés

Versions (1)
  1. 12/09/2019 12/09/2019 -
Détendeur de droits

JHSPH Center for Clinical Trials

Téléchargé le

12 septembre 2019

DOI

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Licence

Creative Commons BY-NC 3.0
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Losartan Effects on Emphysema Progression NCT02696564

Anglais

Eligibility Criteria

1 Formulaires  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
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?
Description

Mild to severe COPD

Type de données

boolean

Alias
UMLS CUI [1,1]
C2945599
UMLS CUI [1,2]
C0024117
UMLS CUI [2,1]
C0205082
UMLS CUI [2,2]
C0024117
UMLS CUI [3]
C0438193
UMLS CUI [4]
C0860907
Is the participant a current or former smoker?
Description

Current or former smoker

Type de données

boolean

Alias
UMLS CUI [1]
C3241966
UMLS CUI [2]
C0337671
Does the participant have a HRCT scan with 5-35% of voxels with density less than -950 Hounsfield Units (HU)?
Description

HRCT scan

Type de données

boolean

Alias
UMLS CUI [1,1]
C0412612
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C2700259
UMLS CUI [1,4]
C0178587
UMLS CUI [1,5]
C0205251
Does the participant have the ability to understand and willingness to sign consent documents?
Description

Informed consent

Type de données

boolean

Alias
UMLS CUI [1,1]
C1273101
UMLS CUI [1,2]
C0009797
UMLS CUI [2,1]
C0600109
UMLS CUI [2,2]
C1519316
UMLS CUI [2,3]
C0009797
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Does the participant have current therapy with angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB)?
Description

ACE or ARB therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C2827774
UMLS CUI [1,2]
C0003015
UMLS CUI [2,1]
C2827774
UMLS CUI [2,2]
C0521942
Does the participant have a known intolerance to ACE inhibitor or ARB?
Description

ACE inhibitor or ARB intolerance

Type de données

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0003015
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0521942
Does the participant have a history of angioedema?
Description

History of angioedema

Type de données

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0002994
Does the participant have a conventional indication for ACE inhibitor or ARB (e.g., history of myocardial infarction, known cardiomyopathy)?
Description

Conventional indication for ACE inhibitor or ARB

Type de données

boolean

Alias
UMLS CUI [1,1]
C0439858
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0003015
UMLS CUI [2,1]
C0439858
UMLS CUI [2,2]
C3146298
UMLS CUI [2,3]
C0521942
Does the participant have renal insufficiency (GFR <30 mL/min by Cockcroft-Gault calculation)?
Description

Renal insufficiency

Type de données

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C4544895
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?
Description

Current regular NSAID use

Type de données

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C0003211
Does the participant have a potassium supplementation or serum potassium level of 5.0 milliequivalents (mEq)/dL or higher at V1?
Description

Potassium supplementation or serum potassium level

Type de données

boolean

Alias
UMLS CUI [1]
C0561938
UMLS CUI [2,1]
C0302353
UMLS CUI [2,2]
C0205250
Does the participant have a current use of a potassium sparing diuretic?
Description

Current potassium sparing diuretic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0304490
Does the participant have a COPD exacerbation requiring treatment within 6 weeks at V1?
Description

COPD exacerbation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0740304
UMLS CUI [1,2]
C0027552
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0332185
Does the participant have a chronic systemic corticosteroid use of more than 10mg/day of prednisone?
Description

Chronic systemic corticosteroid use

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205191
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0239126
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?
Description

Resting SpO2

Type de données

boolean

Alias
UMLS CUI [1,1]
C4699029
UMLS CUI [1,2]
C0428179
UMLS CUI [1,3]
C0205251
UMLS CUI [1,4]
C2016156
UMLS CUI [1,5]
C4531406
UMLS CUI [2,1]
C0238617
UMLS CUI [2,2]
C4699029
UMLS CUI [2,3]
C0428179
UMLS CUI [2,4]
C0205251
UMLS CUI [2,5]
C2016156
UMLS CUI [2,6]
C0205250
UMLS CUI [2,7]
C4531406
Does the participant have untreated arterial hypertension (systolic blood pressure greater than140 mm Hg, diastolic blood pressure greater than 90 mm Hg)?
Description

Untreated arterial hypertension

Type de données

boolean

Alias
UMLS CUI [1]
C0745134
UMLS CUI [2]
C0277884
UMLS CUI [3]
C0277889
Does the participant have blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic while standing or sitting?
Description

Low blood pressure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0231472
UMLS CUI [1,2]
C0277885
UMLS CUI [2,1]
C0231472
UMLS CUI [2,2]
C0277890
UMLS CUI [3,1]
C0277814
UMLS CUI [3,2]
C0277885
UMLS CUI [4,1]
C0277814
UMLS CUI [4,2]
C0277890
Does the participant have known unilateral or bilateral renal artery stenosis higher than 70%?
Description

Unilateral/Bilateral renal artery stenosis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205309
UMLS CUI [1,2]
C0856759
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0205309
UMLS CUI [2,2]
C0856760
UMLS CUI [2,3]
C0205082
Does the participant have a previous lung resection surgery?
Description

Previous lung resection surgery

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0396565
Does the participant have evidence of interstitial, occupational or chronic infectious lung disease?
Description

Infectious lung disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332120
UMLS CUI [1,2]
C0596790
UMLS CUI [1,3]
C0876973
UMLS CUI [2,1]
C0332120
UMLS CUI [2,2]
C0521127
UMLS CUI [2,3]
C0876973
UMLS CUI [3,1]
C0332120
UMLS CUI [3,2]
C0205191
UMLS CUI [3,3]
C0876973
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)?
Description

Changes to chest precluding HRCT

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C0817096
UMLS CUI [1,3]
C4743675
UMLS CUI [1,4]
C0412612
UMLS CUI [2]
C2826620
UMLS CUI [3]
C0522670
UMLS CUI [4]
C1283151
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?
Description

For women of child bearing potential

Type de données

boolean

Alias
UMLS CUI [1]
C0240802
UMLS CUI [2,1]
C0558080
UMLS CUI [2,2]
C0004764
UMLS CUI [2,3]
C0489652
UMLS CUI [3,1]
C0558080
UMLS CUI [3,2]
C0036899
UMLS CUI [3,3]
C0489652
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?
Description

Major chronic illnesses

Type de données

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0027765
UMLS CUI [6]
C0004936
UMLS CUI [7]
C0014130
UMLS CUI [8]
C1882062
UMLS CUI [9]
C2733146
UMLS CUI [10]
C2732402
UMLS CUI [11,1]
C0019693
UMLS CUI [11,2]
C0205318
UMLS CUI [12]
C1532237
UMLS CUI [13]
C0020550
UMLS CUI [14]
C0014544
UMLS CUI [15,1]
C0006826
UMLS CUI [15,2]
C4723751
UMLS CUI [15,3]
C1123023
UMLS CUI [16]
C3495832
Does the participant have a failure to keep screening appointments or other indicators of non-adherence?
Description

Non-adherence

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680095
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1710032
UMLS CUI [2,1]
C0021212
UMLS CUI [2,2]
C0457432
Does the participant have an inability to be contacted by telephone?
Description

No telephone contact

Type de données

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0332158
UMLS CUI [1,3]
C0039457
Does the participant have the intention to leave area within 12 months?
Description

Intention to leave area soon

Type de données

boolean

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C1706081
UMLS CUI [1,3]
C0205146
UMLS CUI [1,4]
C4018905
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Similar models

Eligibility Criteria

1 Formulaires
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
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])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
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])
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