Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the role of the pulmonary vasculature in the development and progression of chronic obstructive pulmonary disease (COPD). To accomplish this, an inhaled prostacyclin (iloprost) will be given to patients with COPD and changes in oxidative stress and lung volumes during exercise will be measured.
Chronic obstructive pulmonary disease (COPD), the 3rd leading cause of death in the US, is a progressive disorder for which new treatments are urgently needed, as existing therapies are focused primarily on symptom relief. Oxidative stress, in part arising from inducible nitric oxide synthase (iNOS) released by the pulmonary vasculature, is critical for the development and progression of COPD; a treatment strategy focused on the pulmonary vasculature is hypothesized to be beneficial in COPD patients. This will be studied with the use of an inhaled prostacyclin analogue, iloprost, which has been approved for pulmonary hypertension and investigated in small studies of COPD patients. Potential mechanisms include reductions in dynamic hyperinflation during exercise in COPD patients or improvements in oxidative stress
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Nebulized normal saline. Single administration |
|
| Inhaled iloprost 5.0 mcg | Experimental | Single administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled iloprost 5.0 mcg | Drug | Single administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic hyperinflation during maximal cardiopulmonary exercise test | Dynamic hyperinflation will be measured as EELV/TLC ratio (end-expiratory lung volume/total lung capacity ratio) during exercise | Acute response (exercise testing performed 30 minutes after study drug administration) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood markers of oxidative stress | 8-isoprostane, superoxide dismutase, catalase, nitrite, malondialdehyde | Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration) |
| Blood markers of inflammation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthew R Lammi, MD | LSU Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LSU Health Sciences Center | New Orleans | Louisiana | 70125 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 8, 2019 | |
| Reset | Apr 3, 2019 | |
| Release | Apr 3, 2019 | |
| Reset | Apr 24, 2019 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 8, 2019 | Apr 3, 2019 | |||
| Apr 3, 2019 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Single administration |
|
|
IL-1 beta, IL-6, IL-8, IL-10, IL-13, IL-18, TNF-alpha
| Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration) |
| Dead space fraction | Acute response (measured every 2 minutes during exercise, starting 30 minutes after study drug administration) |
| B-type natriuretic peptide | Acute response (measured 30 and 40 minutes after study drug administration) |
| Partial pressure of oxygen | Acute response (measured 30 minutes after study drug administration and every 2 minutes during exercise) |
| Metabolic and gas exchange parameters during cardiopulmonary exercise test | Acute response (throughout exercise, starting 30 minutes after study drug administration) |
| Blood cyclic AMP levels | Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration) |
| Blood iloprost levels | Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration) |
| Exercise time and external work performed | measured during exercise test 30 minutes after study drug administration |
| Borg dyspnea and leg scores | During exericse (starting 30 minutes after study drug administration) |
| Apr 24, 2019 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |