Results of a Phase 2b clinical trial suggest actigraphy as a relevant tool to detect meaningful clinical changes in patients with pulmonary hypertension (PH) associated with interstitial lung disease (PH-ILD) when treated with Bellerophon Therapeutics’ product INOpulse. PH-ILD includes PH patients with idiopathic pulmonary fibrosis (PH-IPF).
The findings are being presented at the 13th Annual Pulmonary Vascular Research Institute World Congress on Pulmonary Vascular Disease, in Spain (Jan. 31 to Feb. 3), in a poster presentation titled “Actigraphy as a clinically meaningful endpoint to detect change after treatment with iNO (30 mcg/kg-IBW/hr) in patients at risk of Pulmonary Hypertension associated with Pulmonary Fibrosis.”
Actigraphy is a wearable medical device applied to the participant’s wrist to monitor motor activity; its data correlates with the patient’s functional abilities and clinical outcomes. The device is being used as primary endpoint in clinical trials testing other cardiopulmonary conditions, including chronic obstructive pulmonary disorder (COPD).
INOpulse is a portable pulsing device that delivers inhaled nitric oxide (iNO) by adjusting its dosing according to the breathing pattern of patients. Inhalation of nitric oxide can relax smooth muscle cells in blood vessels, and subsequently reduce both blood pressure in the lung and tension in the heart’s right ventricle — two hallmarks of PH.
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The ongoing iNO-PF Phase 2b study (NCT03267108) is testing the safety and effectiveness of iNO treatment in patients with pulmonary fibrosis. So far, 41 participants have been tested; they are receiving either iNO (30 mcg/kg ideal body weight/per hour) or placebo, including a one-week run-in period and an eight-week treatment period.
The trial uses actigraphy to assess clinically relevant parameters in participants treated with iNOpulse.
The latest results showed that PH-IPF participants treated with INOpulse had an 8% increase in moderate activity (walking, stairs, yardwork, etc.) compared with those receiving placebo, who experienced a 26% decline.
Comparison of overall activity showed that iNO-treated participants had no decline, while control group participants showed a 12% average decline in their overall activity levels.
“Evaluating real-world physical activity in patients suffering from cardiopulmonary diseases provides invaluable insight in assessing disease progression and overall patient well-being,” James Loyd, MD, said in a press release. Loyd is professor of medicine at Vanderbilt University Medical Center, and a principal investigator in the iNO-PF study.
“I believe that actigraphy provides clinically meaningful data sensitive to functional change following treatment with INOpulse. Based on my experience and the clinical data generated to date, I am confident that INOpulse has the unique potential to become the first therapy to treat PH-ILD, a disease with a serious unmet medical need,” Loyd concluded.
The iNO-PF trial is currently assessing higher doses of iNO.
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