Evaluation of Inhaled Iloprost Effects Using the Breelib Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension (VENTASTEP)

Bayer

Status: Completed

Conditions: Hypertension, Pulmonary

Treatments: Drug: Iloprost (Ventavis, BAYQ6256); Device: Breelib nebulizer

Study type: Observational

Funder types: Industry

Identifiers

NCT03293407

19398

Details and patient eligibility

About

The main aim of the observational VENTASTEP study was to investigate the association between changes in clinical outcome measures and changes in device outcome measures in PAH patients using the new Breelib nebulizer in a real life setting.

The study was not designed to investigate or confirm the effectiveness and safety of iloprost.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ventavis-treatment naïve patients aged ≥18 years at initiation of Ventavis (Iloprost) therapy diagnosed with pulmonary arterial hypertension WHO FC III
• Patients who are planned to be treated with Ventavis (Iloprost) and where the decision to use the Breelib has been agreed by physician and patient
• Patients who are willing to wear a smart watch (iWatch2) over the observation period of 3 months ± 2 weeks
• Signed informed consent

Exclusion criteria

• Patients allergic to Nickel and Methacrylates
• Patients participating in an investigational program with interventions outside of routine clinical practice

Trial design

31 participants in 1 patient group

BAYQ6256_Ventavis

Description:

Patients with pulmonary hypertension who agree to be treated with Ventavis (Iloprost) at the discretion of physician

Treatment:

Drug: Iloprost (Ventavis, BAYQ6256)

Device: Breelib nebulizer