TerminatedEarly Phase 1

Effect iNO on Functional Respiratory Imaging in Subjects With WHO Group 3 Pulmonary Hypertension With COPD on Oxygen

Stopped: This was an exploratory open-label study and has met its initial objectives

Belgium7 participantsStarted 2016-10

Plain-language 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 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.

Who can participate

Age range40 Years – 85 Years

SexALL

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Exclusion criteria

✕. start of or increase in systemic oral corticosteroid therapy and/or
✕. hospitalization 5. 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 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:

What they're measuring

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.

Timeframe: After 4 weeks of treatment

Trial details

NCT IDNCT03135860

SponsorBellerophon

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-08-21

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