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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-01-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension, Pulmonary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BAYQ6256_Ventavis

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

Iloprost (Ventavis, BAYQ6256)

Intervention Type DRUG

Using Breelib device

Breelib nebulizer

Intervention Type DEVICE

Used for inhalation of Ventavis

Interventions

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Iloprost (Ventavis, BAYQ6256)

Using Breelib device

Intervention Type DRUG

Breelib nebulizer

Used for inhalation of Ventavis

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No