EUCTR2016-002389-29-BE
Active, not recruiting
Phase 1
An Exploratory Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide (iNO) on Functional Respiratory Imaging (FRI) Parameters 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).
Bellerophon Pulse Technologies, LLC0 sitesJune 28, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bellerophon Pulse Technologies, LLC
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patient
- •2\. A confirmed diagnosis of COPD by the Global initiative for chronic Obstructive Lung Disease (GOLD) criteria
- •3\. Pulmonary hypertension will be defined as sPAP \= 38 mmHg as determined by echocardiogram (not obtained within ± 7 days of an exacerbation) within the past 12 months.
- •4\. Current or former smokers with at least 10 pack\-years of tobacco cigarette smoking before study entry
- •5\. Age \= 40 years, \= 85 years
- •6\. A post\-bronchodilatory 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)
- •7\. Receiving LTOT for \= 3 months and \= 10 hours per day as determined by history
- •8\. Females of childbearing potential must have a negative pre\-scan urine pregnancy test
- •9\. Signed informed consent prior to the initiation of any study mandated procedures or assessments.
- •Are the trial subjects under 18? no
Exclusion Criteria
- •1\. Males who have the intention to father a child during the study.
- •2\. A diagnosis of asthma or other non\-COPD respiratory disease, in the opinion of the Investigator
- •3\. Lack of patency of nares upon physical examination
- •4\. Experienced during the last month an exacerbation requiring:
- •a) start of or increase in systemic oral corticosteroid therapy and/or
- •b) hospitalization
- •5\. Left ventricular dysfunction as measured by:
- •a) Screening echocardiographic evidence of left ventricular systolic dysfunction (left ventricular ejection fraction \[LVEF] \< 40%), or
- •b) Screening echocardiographic evidence of left ventricular diastolic dysfunction \> moderate (i.e., \> Grade 3\), or
- •c) Any history of pulmonary capillary wedge pressure (PCWP), left atrial pressure (LAP) or left ventricular end diastolic pressure (LVEDP) \> 18 mmHg as measured during cardiac catheterization
Outcomes
Primary Outcomes
Not specified
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