Bayer is sponsoring a long-term observational clinical trial involving patients with pulmonary hypertension or pulmonary arterial hypertension due to scleroderma. The aim of the study is to determine the efficacy, safety, and tolerability of inhaled Ventavis (iloprost, also known as BAYQ6256) in 160 patients with either idiopathic or familial PH/PAH for up to four years.
Patients under observation are considered to be in the worst New York Heart Association (NYHA) Functional Classes (class III and IV). No healthy volunteers are accepted for the trial, and patients cannot have significant interstitial pulmonary disease. Enrollment is still active for the trial.
As an open-label study, “Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years (OPTION)” does not have strict prescribing criteria or comparison against a placebo. Rather, patients are prescribed inhaled iloprost by their physicians as medically required for up to four years. The study, initiated in February 2011, was last updated in November 2014 and is expected to be completed by June 2017.
At the conclusion of the study, researchers will evaluate the primary outcome measures of change in six minute walking distance, adverse events, patient weight, and vital findings. Additionally, changes in NYHA Functional Class and dosage and frequency of drug administration, as well as records of PH-related hospitalization, heart or lung transplantation, and mortality, will be considered as secondary measures.
According to the Pulmonary Hypertension Association, iloprost acts by dilating blood vessels in the lungs, allowing blood pressure to be reduced. Generally, this enable patients to be more active. The medicine is delivered using a special device (I-neb AAD System) that is small, portable, and rechargeable. With the conclusion of the present trial, Bayer will be able to further confirm the safety and efficacy of this treatment.