This was an exploratory open-label study and has met its initial objectives
Effect iNO on Functional Respiratory Imaging in Subjects With WHO Group 3 Pulmonary Hypertension With COPD on Oxygen
Exploratory Study to Assess the Effect of Pulsed Inhaled Nitric Oxide on Functional Respiratory Imaging Parameters in Subjects With WHO Group 3 Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (COPD) on Long Term Oxygen Therapy (LTOT).
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 long term iNO administrationusing the device INOpulse for 4 weeks in relation to Patient Reported Outcome (PRO) and exercise tolerance in subjects with WHO Group 3 PH associated with COPD on LTOT.
Changes from baseline to 4 weeks of pulsed iNO and after 2 weeks of withdrawal from pulsed iNO will be evaluated.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
terminated
Actual enrollment (reported)
7 participants
Study completion date
August 21, 2017
Actual (reported)
Listed locations
1 countries · 1 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
change in lobar blood volume at total lung capacity with iNO and the change in lobar blood volume with iNO after 4 weeks of treatment with iNO as measured by HRCT.
The primary endpoint in this exploratory study is the change in lobar blood volume at total lung capacity with iNO and the change in lobar blood volume with iNO after 4 weeks of treatment with iNO as measured by HRCT.
After 4 weeks of treatment
Secondary Outcomes (11)
Blood vessel % and density on lobar level
after 4 weeks of treatment
• Blood vessel % and density on lobal level compared among patients with emphysema, chronic bronchitis or combined emphysema and chronic bronchitis as assessed by HRCT
after 4 week of treatment
Study Arms (1)
Inhaled Nitric Oxide 30mcg/kg/IBW/hr
EXPERIMENTAL
Inhaled nitric oxide 30 mcg/kg IBW/hr NO will be administered through the InoPulse Device open label for 4 weeks
Drug: Inhaled Nitric Oxide 30mcg/kg IBW/hr
Interventions
Inhaled Nitric Oxide 30mcg/kg IBW/hrDrug
Inhaled Nitric Oxide 30 mcg/kg IBW/hr will be administered through the INOPulse Device open label for 4 weeks
Also known as: iNO, NO,
Inhaled Nitric Oxide 30mcg/kg/IBW/hr
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Eligibility Criteria
Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
You may qualify if:
\- 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.
Internal airflow distribution based on lobar expansion
after 4 weeks of treatment
+6 more secondary outcomes
\. 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
You may not qualify if:
\. 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:
start of or increase in systemic oral corticosteroid therapy and/or
hospitalization 5. Left ventricular dysfunction as measured by:
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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 3), 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 6. Renal impairment (i.e., an estimated GFR CKD-EPI \< 30 ml/min/1.73 m2) or history of renal failure using the equation:
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.
\. 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
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