Ventavis® (Iloprost): Evaluation of Inhaled Iloprost Effects Using the Breelib™ Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Change of laboratory results of the biomarkers NT-pro BNP/BNP
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
BAYQ6256_Ventavis
Patients with pulmonary hypertension who agree to be treated with Ventavis (Iloprost) at the discretion of physician
Intervention: Iloprost (Ventavis, BAYQ6256) (Drug)
BAYQ6256_Ventavis
Patients with pulmonary hypertension who agree to be treated with Ventavis (Iloprost) at the discretion of physician
Intervention: Breelib nebulizer (Device)
Outcomes
Primary Outcomes
Change of laboratory results of the biomarkers NT-pro BNP/BNP
Time Frame: Baseline and 3 months
Change of World Health Organization functional class
Time Frame: Baseline and 3 months
Change of Number of Steps per day
Time Frame: Baseline and 3 months
Change of number of floors climbed (10 feet) per day
Time Frame: Baseline and 3 months
Change of time spent at home per day
Time Frame: Baseline and 3 months
Change of number of times standing up per day
Time Frame: Baseline and 3 months
Change of 6MWD
Time Frame: Baseline and 3 months
Device based outcome measured by smart device.
Change of Six-minute walking distance (6MWD)
Time Frame: Baseline and 3 months
Clinical outcome measured by study nurse.
Change of number of relevant location changes per day
Time Frame: Baseline and 3 months
Change of Distance Walked per day
Time Frame: Baseline and 3 months
Change of Health related Quality of Life-EuroQol five dimensions questionnaire (EQ-5D)
Time Frame: Baseline and 3 months
Change of number of times leaving home per day
Time Frame: Baseline and 3 months
Heart rates during baseline and observation period
Time Frame: Up to 3 months
Secondary Outcomes
- Change of sleep quality(Baseline and 3 months)
- The average daily proportion of complete/incomplete inhalations(Up to 3 months)
- The average number of daily inhalations(Up to 3 months)
- The average daily inhalation duration per session(Up to 3 months)
- Incidence of AEs(Up to 3 months after first inhalation)
- Change of heart rate during 6MWD(Baseline and 3 months)
- The average association between physical activity level (wearable device based) and time to last inhalation(Up to 3 months)