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news.US-based biotherapeutics firm Bellerophon Therapeutics has completed enrollment of its 159-patient Phase II clinical trial of INOpulse to treat pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD).
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PH-COPD is a serious complication of COPD that can affect the health status of patients with this condition.
Current standard of care for PH-COPD patients is primarily limited to oxygen therapy, pulmonary rehabilitation and lung transplant.
The move follows the previously announced completion of enrollment for the company’ 80-patient Phase II trial of INOpulse to treat pulmonary arterial hypertension (PAH).
The INOpulse device delivers brief, controlled pulses of inhaled nitric oxide, which is a selective, short-acting pulmonary vasodilator.
The randomized, double-blind, placebo-controlled short-term dose response trial evaluates acute hemodynamic responses in patients to inform the dose selection for the next phase of clinical development of INOpulse for PH-COPD.
The company expects to complete the Phase II trial in the third quarter of 2014.