Bellerophon Therapeutics LLC, a clinical stage biotherapeutics company, has completed enrollment of its 159-patient Phase 2 clinical trial of INOpulse for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD).
PH-COPD is a serious complication of COPD that can significantly affect the health status of patients with this condition. Current standard of care is primarily limited to oxygen therapy, pulmonary rehabilitation and lung transplant.
Bellerophon’s INOpulse device delivers brief, controlled pulses of inhaled nitric oxide, which is a selective, short-acting pulmonary vasodilator. INOpulse is portable, which is intended to allow for treatment of ambulatory patients on daily basis outside the hospital.
This Phase 2 trial, conducted at 43 sites in the United States, is a randomized, double-blind, placebo-controlled short-term dose response trial of INOpulse for patients with PH-COPD. The trial assesses acute hemodynamic responses in patients to inform the dose selection for the next phase of clinical development of INOpulse for PH-COPD. The trial is expected to be completed in the third quarter of 2014.
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