| ID | Type | Description | Link |
|---|---|---|---|
| 1P50HL084945 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Merck Sharp & Dohme LLC | INDUSTRY |
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Evidence in animals shows that losartan can prevent or reverse inflammation and lung damage due to smoking. The goal of this study is to determine whether this drug which is also used to treat hypertension can stabilize or improve lung function in people who have from chronic obstructive pulmonary disease (COPD).
Participants will be given either losartan in a dose of 50-100 mg per day for a period of one year. During that time, they will have lung function tests, breathing tests, and computed tomograms of the chest. These tests will determine whether there is inflammation in the lung and whether there is progressive involvement of the lung with COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan | Experimental | Losartan 100 mg daily |
|
| Placebo | Placebo Comparator | Placebo 1 pill daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan | Drug | Losartan 100 mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent Emphysema on CT Scan | Percent emphysema calculated as percent of CT voxels less than -950 HU measured at TLC. Analysis limited to patients with 5-35% emphysema on CT scan at baseline. | Change between baseline and month 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FEV1 (L) | Change in FEV1 (L) post-bronchodilator from baseline to 12 months. Analysis includes only participants with 5-35% emphysema at baseline. | Measured at Baseline and Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert A. Wise, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Asthma and Allergy Center | Baltimore | Maryland | 21205 | United States |
Limited dataset available to qualified investigators with data use agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Losartan | Losartan 100 mg daily Losartan: Losartan 100 mg daily |
| FG001 | Placebo | Placebo 1 pill daily Placebo: Placebo pill daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Losartan | Losartan 100 mg daily |
| BG001 | Placebo | Placebo 1 tablet daily |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Percent Emphysema on CT Scan | Percent emphysema calculated as percent of CT voxels less than -950 HU measured at TLC. Analysis limited to patients with 5-35% emphysema on CT scan at baseline. | Participants with 5-35% emphysema on baseline CT scan | Posted | Mean | Standard Deviation | % Emphysema Whole Lung | Change between baseline and month 12. |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Losartan 100 mg Daily | Losartan 100 mg daily Losartan: Losartan 100 mg daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of respiratory symptoms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Study was designed as feasibility study for assessment of variability of outcomes and tolerability of treatment in patients with pre-existing emphysema in association with COPD.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert A. Wise | Johns Hopkins University School of Medicine | 410 550 0545 | rwise@jhmi.edu |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| D029481 | Bronchitis, Chronic |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | Placebo pill daily |
|
|
| Total |
Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| FEV1 (L) | Participants with analyzable data pre-bronchodilator | Mean | Standard Deviation | L (BTPS) |
|
| FEV1/FVC (%) | Ratio of Forced Expiratory Volume in 1 second (FEV1) divided by Forced Vital Capacity (FVC) and then multiplied by 100 to give the ratio in percent. | Participants with analyzable data from pre-bronchodilator spirometry | Mean | Standard Deviation | percent |
|
| Smoking Status | Number | participants |
|
| Emphysema on HRCT | Emphysema was measured as percent of lung voxels with Hounsfield units (HU) less than -950 HU. Participants with 5-35% of lung parenchyma with HU < -950 were considered to have radiographic emphysema. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change in FEV1 (L) | Change in FEV1 (L) post-bronchodilator from baseline to 12 months. Analysis includes only participants with 5-35% emphysema at baseline. | Participants with 5-35% emphysema at baseline who had HRCT scans performed both at baseline and at 12 months. | Posted | Mean | Standard Deviation | L (BTPS) | Measured at Baseline and Month 12 |
|
|
|
|
| 0 |
| 54 |
| 7 |
| 54 |
| 19 |
| 54 |
| EG001 | Placebo | Placebo 1 pill daily Placebo: Placebo pill daily | 1 | 52 | 18 | 52 | 24 | 52 |
| Worsening of gastrointestinal symptoms | Gastrointestinal disorders | Non-systematic Assessment |
|
| Worsening of musculoskeletal symptoms or fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D001519 | Behavior |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D002241 | Carbohydrates |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|