Ventavis® (Iloprost): Evaluation of Inhaled Iloprost Effects Using the Breelib™ Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension
| Registry | NCT03293407, acronym VENTASTEP |
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| Status | Completed |
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| Study type | Observational |
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| Enrollment | 31 (Actual) |
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| Sponsor | Bayer (Industry) |
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| Conditions | Hypertension, Pulmonary |
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| Interventions | Iloprost (Ventavis, BAYQ6256), Breelib nebulizer (Drug, device) |
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| Dates | start 2018-02-01, primary completion 2019-10-09, completion 2020-01-20, first posted 2017-09-26, last updated 2021-05-26 |
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| Locations | 1 site in Germany |
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-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| BAYQ6256_Ventavis | | Drug: Iloprost (Ventavis, BAYQ6256); Device: Breelib nebulizer | Patients with pulmonary hypertension who agree to be treated with Ventavis (Iloprost) at the discretion of physician |
- Iloprost (Ventavis, BAYQ6256) (Drug): Using Breelib device
- Breelib nebulizer (Device): Used for inhalation of Ventavis
+Outcome measures
Primary outcomes
- Change of Six-minute walking distance (6MWD) [Baseline and 3 months]: Clinical outcome measured by study nurse.
- Change of laboratory results of the biomarkers NT-pro BNP/BNP [Baseline and 3 months]
- Change of Health related Quality of Life-EuroQol five dimensions questionnaire (EQ-5D) [Baseline and 3 months]
- Change of World Health Organization functional class [Baseline and 3 months]
- Change of Distance Walked per day [Baseline and 3 months]
- Change of Number of Steps per day [Baseline and 3 months]
- Change of number of floors climbed (10 feet) per day [Baseline and 3 months]
- Change of time spent at home per day [Baseline and 3 months]
- Change of number of relevant location changes per day [Baseline and 3 months]
- Change of number of times leaving home per day [Baseline and 3 months]
- Change of number of times standing up per day [Baseline and 3 months]
- Change of 6MWD [Baseline and 3 months]: Device based outcome measured by smart device.
- Heart rates during baseline and observation period [Up to 3 months]
Secondary outcomes
- The average daily inhalation duration per session [Up to 3 months]
- The average number of daily inhalations [Up to 3 months]
- Change of sleep quality [Baseline and 3 months]: Measured by Pittsburgh Sleep Quality Index (PSQI).
- Incidence of AEs [Up to 3 months after first inhalation]
- Change of heart rate during 6MWD [Baseline and 3 months]
- The average daily proportion of complete/incomplete inhalations [Up to 3 months]
- The average association between physical activity level (wearable device based) and time to last inhalation [Up to 3 months]
+Eligibility
Sex: All, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
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| Many Locations | Multiple Locations | Germany | |
+Publications
- Mueller C, Stollfuss B, Roitenberg A, Harder J, Richter MJ. Evaluation of Clinical Outcomes and Simultaneous Digital Tracking of Daily Physical Activity, Heart Rate, and Inhalation Behavior in Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost: Protocol for the Observational VENTASTEP Study. JMIR Res Protoc. 2019 Apr 15;8(4):e12144. doi: 10.2196/12144. PMID 30985279
- Results publication: Stollfuss B, Richter M, Dromann D, Klose H, Schwaiblmair M, Gruenig E, Ewert R, Kirchner MC, Kleinjung F, Irrgang V, Mueller C. Digital Tracking of Physical Activity, Heart Rate, and Inhalation Behavior in Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost: Observational Study (VENTASTEP). J Med Internet Res. 2021 Oct 8;23(10):e25163. doi: 10.2196/25163. PMID 34623313