FLUIDDA’s FRI Technology was used in a Positive Phase II Trial with iNOpulse® for Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD)

“Functional Respiratory Imaging (FRI) provided valuable insights throughout the development process of iNO in COPD patients with PH. The therapy was effective in the initial studies and has great potential to improve the lives of these severely affected patients”

Dr. J. De Backer, CEO FLUIDDA

 

Changes in Blood Vessel Volume determined using Functional Respiratory Imaging (FRI)

The Phase 2 study was designed to assess the acute effect of pulsed inhaled nitric oxide (iNO) on targeted vasodilation and the chronic effect (4 weeks) of iNO on hemodynamics and exercise capacity.  The study enrolled 10 subjects and used a dose of 30 mcg/kg IBW/hr (iNO 30).  The acute results showed a statistically significant increase (average 4.2%) in blood vessel volume  on iNO compared to baseline (p=0.03), and a statistically significant correlation in Ventilation-Vasodilation (p=0.01), indicating targeted delivery to the well-ventilated alveoli. Both blood vessel volume changes and ventilation-vasodilation relations were measured using Functional Respiratory Imaging (FRI). The chronic results demonstrated statistically significant and clinically meaningful increases in six-minute walking distance (6MWD) at both 2 weeks and 4 weeks (+50.7m; p=0.04), as compared to baseline.  In addition, the study demonstrated a statistically significant and clinically meaningful decrease of 19.9% in systolic pulmonary arterial pressure (sPAP) at 4 weeks (p=0.02), as compared to baseline.  The therapy was well tolerated with no related safety concerns.

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