LSU Health Sciences Center
New Orleans, Louisiana, 70125, United States
NCT Number: NCT01941225
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.
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Notify Me40 year and older
All sexes
Interventional
Phase 2
New Orleans, Louisiana, 70125, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single administration
Other names: Ventavis
Single administration
Other names: Nebulized normal saline
Time frame: Acute response (exercise testing performed 30 minutes after study drug administration)
Dynamic hyperinflation will be measured as EELV/TLC ratio (end-expiratory lung volume/total lung capacity ratio) during exercise
Time frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
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)
IL-1 beta, IL-6, IL-8, IL-10, IL-13, IL-18, TNF-alpha
Time frame: Acute response (measured every 2 minutes during exercise, starting 30 minutes after study drug administration)
Time frame: Acute response (measured 30 and 40 minutes after study drug administration)
Time frame: Acute response (measured 30 minutes after study drug administration and every 2 minutes during exercise)
Time frame: Acute response (throughout exercise, starting 30 minutes after study drug administration)
Time frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Time frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Time frame: measured during exercise test 30 minutes after study drug administration
Time frame: During exericse (starting 30 minutes after study drug administration)
Louisiana State University Health Sciences Center in New Orleans
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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