Status:
COMPLETED
3 Part Study to Assess Inhaled Nitric Oxide on Functional Pulmonary Imaging in Subj. Pulmonary Hypertension Associated w/ COPD and IPF
Lead Sponsor:
Bellerophon
Conditions:
Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
Brief Summary
The objective of this exploratory study is to examine the utility of high resolution computed tomography (HRCT) to measure changes in functional pulmonary imaging parameters as a function of short ter...
Detailed Description
This is an exploratory, two-part, clinical study to evaluate the utility of HRCT to measure the pharmacodynamic effects of short term, pulsed administration of iNO using the combination product, inhal...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following inclusion criteria to be enrolled and eligible to participate in the study:
- A confirmed diagnosis of COPD by the Global initiative for chronic Obstructive Lung Disease (GOLD) criteria
- Pulmonary hypertension determined by one of the following within the past 12 months:
- A right heart catheterization (not obtained within ± 7 days of an exacerbation) with an mPAP ≥ 25 mmHg, or
- An echocardiogram (not obtained within ± 7 days of an exacerbation) with a TRV ≥ 2.9 m/s or sPAP ≥ 38 mmHg (Note: a subject with an acceptable mPAP ≥ 25 mmHg determined by right heart catheterization will meet this inclusion criteria even with a TRV \< 2.9 m/s)
- Current or former smokers with at least 10 pack-years of tobacco cigarette smoking before study entry
- Age ≥ 40 years, ≤ 80 years
- 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)
- Receiving LTOT for ≥ 3 months and ≥ 10 hours per day as determined by history
- 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
Exclusion
- Subjects who meet any of the following criteria are not eligible for enrollment:
- 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 during the last month an exacerbation requiring:
- start of or increase in systemic oral corticosteroid therapy and/or
- hospitalization
- 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 mmHg as measured during cardiac catheterization within the past 6 months unless documented to have resolved by a subsequent cardiac catheterization
- Renal impairment (i.e., an estimated GFRMDRD \< 60 ml/min/1.73 m2) or history of renal failure using the equation (Levey et al., 2007):
- estimated GFRMDRD = 175×Scr -1.154×Age-0.203 ×1.212 (if black) ×0.742 (if female)
- where Scr = Standardized serum creatinine
- Known allergy to contrast media.
- 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
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2017
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02267655
Start Date
May 1 2015
End Date
June 28 2017
Last Update
February 21 2023
Active Locations (1)
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1
Antwerp University Hospital
Edegem, Belgium, 2650