Clinical trial NCT03135860 (early phase 1, status: terminated)
Conditions: copd, pulmonary hypertension, chronic obstructive pulmonary disease
ICD codes: I27.0, I27.20, I27.21, I27.24, I27.29, P29.30, I27.22, J44.9, J44.1, J44.0
Drugs: inhaled nitric oxide 30mcg/kg ibw/hr
SMILES: OC[C@H]1O[C@H]([C@H](O)[C@@H]1O)N1C=NC2=C1NC=NC2=O
Reason stopped: 
    this was an exploratory open-label study and has met its initial objectives
  
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

        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:

               1. start of or increase in systemic oral corticosteroid therapy and/or

               2. hospitalization 5. Left ventricular dysfunction as measured by:

               1. Screening echocardiographic evidence of left ventricular systolic dysfunction
                  (left ventricular ejection fraction [LVEF] < 40%), or

               2. Screening echocardiographic evidence of left ventricular diastolic dysfunction
                  >moderate (i.e., > Grade 3), or

               3. 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 6. Renal impairment (i.e., an
                  estimated GFR CKD-EPI < 30 ml/min/1.73 m2) or history of renal failure using the
                  equation:

                  Men:

                  crs< 0.9 mg/dL: eGFRCKD-EPI = 141 × (crs /0.9)-0.411 × 0.993Age crs≥ 0.9 mg/dL:
                  eGFRCKD-EPI = 141 × (crs /0.9)-1.209 × 0.993Age

                  Woman:

                  crs< 0.7 mg/dL: eGFRCKD-EPI = 144 × (crs /0.7)-0.329 × 0.993Age crs≥ 0.7 mg/dL:
                  eGFRCKD-EPI = 144 × (crs /0.7)-1.209 × 0.993Age where crs= Normal and elevated
                  serum creatinine Subjects with possible compromised kidney function (i.e.,
                  Glomerular Filtration Rate estimated using the Modification of Diet in Renal
                  Disease equation [eGFR CKD-EPI] between 30 and 60 ml/min/1.73 m2) may be enrolled
                  provided the Radiology Department and Principal Investigator review the medical
                  records of subjects with an eGFR CKD-EPI between 30 and 60 ml/min/1.73 m2 in
                  order to confirm the contrast agent can be safely administered to these subjects
                  and approval by both the Radiology Department and Principal Investigator must be
                  obtained before enrolling these subjects.

                  7. Known allergy to contrast media. 8. 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 9. 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) 10. Use of investigational drugs or devices
                  within 30 days prior to enrollment into the study 11. Any underlying medical or
                  psychiatric condition that, in the opinion of the Investigator, makes the subject
                  an unsuitable candidate for the study