Two-Part Dose-Confirming Study of Pulsed Inhaled Nitric Oxide in Subjects With WHO Group 3 Pulmonary Hypertension Associated With COPD

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease

In brief

This is a placebo-controlled, double-blind, parallel, randomized, two-part, dose-confirming clinical study characterizing the pharmacodynamic effects of pulsed iNO using the combination product, inhaled nitric oxide/INOpulse DS-C vs. placebo in subjects with World Health Organization (WHO) Group 3 pulmonary hypertension (PH) associated with Chronic Obstructive Pulmonary Disease (COPD) on Long Term Oxygen Therapy (LTOT).

Key facts

Study ID

NCT01728220

Run by

Bellerophon Pulse Technologies

People needed

159

Starts

2012-12-01

Expected to finish

2014-07-01

Last updated by the study team

2023-02-27

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Former smokers with at least 10 pack-years of tobacco cigarette smoking history before study entry and who have stopped smoking ≥ 1 month prior to enrollment
• Age ≥ 40 years, ≤ 80 years
• A confirmed diagnosis of COPD by the Global initiative for chronic Obstructive Lung Disease (GOLD) criteria
• A post-bronchodilatory forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 0.7 and a FEV1 < 60% predicted (values obtained within 6 months prior to screening can be used unless obtained within ± 7 days of an exacerbation; otherwise, the test must be performed during screening)
• Receiving LTOT for ≥ 3 months and ≥ 10 hours per day as determined by history
• Echocardiogram with technical adequacy demonstrating tricuspid regurgitation velocity (TRV) ≥ 2.9 m/s at Screening, as determined by a blinded central echocardiography laboratory
• Females of childbearing potential must have a negative pre-treatment urine pregnancy test
• Signed informed consent prior to the initiation of any study mandated procedures or assessments

You may not qualify if…

• Subjects who meet any of the following criteria are not eligible for enrollment:
• Positive urine cotinine test
• Currently using, or having used within the past month, a nicotine patch
• A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator
• Lack of patency of nares upon physical examination
• Experienced an exacerbation requiring start of or increase in systemic oral corticosteroid therapy and/or hospitalization during the last month (ATS COPD Guidelines 2004)
• Left ventricular dysfunction as measured by:
• Screening echocardiographic evidence of left ventricular systolic dysfunction (left ventricular ejection fraction (LVEF) < 40%), or
• Screening echocardiographic evidence of left ventricular diastolic dysfunction > moderate (i.e., > Grade 2), or
• Any history of pulmonary capillary wedge pressure (PCWP), left atrial pressure (LAP) or left ventricular end diastolic pressure (LVEDP) > 18 mm Hg as measured during cardiac catheterization within the past 6 months unless documented to have resolved by a subsequent cardiac catheterization
• Clinically significant valvular heart disease that may contribute to PH, including mild or greater aortic valvular disease (aortic stenosis or regurgitation) and/or moderate or greater mitral valve disease (mitral stenosis or regurgitation), or status post mitral valve replacement
• Use within 30 days of screening or current use of approved PH medications such as sildenafil or bosentan (use of Cialis® or Viagra® for erectile dysfunction is permitted)
• Use of investigational drugs or devices within 30 days prior to enrollment into the study
• Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study

Where it is running

• Jasper Summit Research LLC — Jasper, Alabama, United States
• Clinical Trial Connection — Flagstaff, Arizona, United States
• Pulmonary Associates P.A. — Phoenix, Arizona, United States
• Radin Cardiovascular Medical Associates — Newport Beach, California, United States
• Western Connecticut Medical Group PC — Danbury, Connecticut, United States
• Waterbury Pulmonary Associates — Waterbury, Connecticut, United States
• Bay Area Chest Physicians — Clearwater, Florida, United States
• Gary J. Richmond, MD, PA — Fort Lauderdale, Florida, United States
• East Coast Institute for Research — Jacksonville, Florida, United States
• Pulmonary Disease Specialists PA — Kissimmee, Florida, United States
• San Marcus Research Clinic Inc. — Miami, Florida, United States
• St. Paul Medical Research Center Inc. — Miami, Florida, United States
• IMIC, Inc. — Miami, Florida, United States
• Elite Clinical Research — Miami, Florida, United States
• South Florida Research Phase I-IV — Miami, Florida, United States
• Health & Life Research Solutions Inc. — Miami, Florida, United States
• Advanced Research Institute, Inc. — New Port Richey, Florida, United States
• Central Florida Pulmonary Group, P.A. — Orlando, Florida, United States
• Bassette Medical Research Inc. — Sebring, Florida, United States
• Research Alliance — St. Petersburg, Florida, United States
• Concept Clinical Trials, LLC — Tamarac, Florida, United States
• Axcess Medical Research — Wellington, Florida, United States
• Florida Premier Research Institute — Winter Park, Florida, United States
• River Birch Research Alliance LLC — Blue Ridge, Georgia, United States
• Medical Associates of North Georgia — Canton, Georgia, United States

Full record on ClinicalTrials.gov

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