Trial Condition(s):

Hypertension, Pulmonary

Evaluation of inhaled iloprost effects using the Breelib nebulizer, on clinical outcomes and physical activity of patients with advanced pulmonary arterial hypertension (VENTASTEP)

Bayer Identifier:

19398

ClinicalTrials.gov Identifier:

NCT03293407

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
31
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, Germany

Status
Completed
 

Trial Design