The primary objective of the double-blind, placebo-controlled trial, known as ACTIVE, is to determine the safety of Ventavis (iloprost) inhalation solution in patients with pulmonary hypertension (PH) associated with mild or moderate idiopathic pulmonary fibrosis (IPF).
The study will also assess other clinically relevant measures including the six-minute walk test, NYHA class change and hemodyamic parameters and will be conducted in approximately 50 patients at 15 sites in the US.
“Ventavis is an ideal candidate to investigate for IPF patients with pulmonary hypertension. Since Ventavis is inhaled, we believe it targets only the non-fibrotic portions of the diseased lung, increasing vasodilation only in the ventilated areas and reducing the potential for mismatched ventilation and pulmonary blood flow, which can lead to heart strain and fainting,” said Dr James Pennington, executive vice president and chief medical officer of CoTherix.
“With Ventavis already on the market in the US for pulmonary arterial hypertension (PAH), this trial underscores our strategy to continue our leadership position in inhaled therapies for pulmonary diseases.”
Ventavis was approved by the FDA in December 2004 for the treatment of PAH in patients with NYHA Class III or IV symptoms. Currently, there are no approved US therapies for IPF or for pulmonary hypertension associated with IPF.