A Phase 2 interventional study of Inhaled iloprost 5.0 mcg and Placebo in Chronic Obstructive Pulmonary Disease, sponsored by Louisiana State University Health Sciences Center in New Orleans. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-12-16.
Sponsored by Louisiana State University Health Sciences Center in New Orleans · Phase 2, Interventional, and Basic science
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
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 24 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Louisiana State University Health Sciences Center in New Orleans is the lead sponsor of 70 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Nebulized normal saline. Single administration
Drug: Placebo
Single administration
Drug: Inhaled iloprost 5.0 mcg
Single administration
Also known as: Ventavis
Single administration
Also known as: Nebulized normal saline
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
Time frame: Acute response (exercise testing performed 30 minutes after study drug administration)
Blood markers of oxidative stress
8-isoprostane, superoxide dismutase, catalase, nitrite, malondialdehyde
Time frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Blood markers of inflammation
IL-1 beta, IL-6, IL-8, IL-10, IL-13, IL-18, TNF-alpha
Time frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Dead space fraction
Time frame: Acute response (measured every 2 minutes during exercise, starting 30 minutes after study drug administration)
B-type natriuretic peptide
Time frame: Acute response (measured 30 and 40 minutes after study drug administration)
Partial pressure of oxygen
Time frame: Acute response (measured 30 minutes after study drug administration and every 2 minutes during exercise)
Metabolic and gas exchange parameters during cardiopulmonary exercise test
Time frame: Acute response (throughout exercise, starting 30 minutes after study drug administration)
Blood cyclic AMP levels
Time frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Blood iloprost levels
Time frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Exercise time and external work performed
Time frame: measured during exercise test 30 minutes after study drug administration
Borg dyspnea and leg scores
Time frame: During exericse (starting 30 minutes after study drug administration)
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Louisiana State University Health Sciences Center in New Orleans