Clinical trial NCT03293407: Evaluation of Inhaled Iloprost Effects Using the Breelib Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension
Official title: Ventavis® (Iloprost): Evaluation of Inhaled Iloprost Effects Using the Breelib™ Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Pulmonary
Keywords: Pulmonary arterial hypertension
PAH
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-09-26
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pulmonary hypertension at intermediate risk and WHO FC III who failed to respond adequately to initial therapy with one or more PAH drugs or who clinically deteriorated after initial treatment response and for whom a therapy escalation with Ventavis (Iloprost) has been agreed by patient and physician.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Six-minute walking distance (6MWD)
timeFrame: Baseline and 3 months
measure: Change of laboratory results of the biomarkers NT-pro BNP/BNP
timeFrame: Baseline and 3 months
measure: Change of Health related Quality of Life-EuroQol five dimensions questionnaire (EQ-5D)
timeFrame: Baseline and 3 months
measure: Change of World Health Organization functional class
timeFrame: Baseline and 3 months
measure: Change of Distance Walked per day
timeFrame: Baseline and 3 months
measure: Change of Number of Steps per day
timeFrame: Baseline and 3 months
measure: Change of number of floors climbed (10 feet) per day
timeFrame: Baseline and 3 months
measure: Change of time spent at home per day
timeFrame: Baseline and 3 months
measure: Change of number of relevant location changes per day
timeFrame: Baseline and 3 months
measure: Change of number of times leaving home per day
timeFrame: Baseline and 3 months
measure: Change of number of times standing up per day
timeFrame: Baseline and 3 months
measure: Change of 6MWD
timeFrame: Baseline and 3 months
measure: Heart rates during baseline and observation period
timeFrame: Up to 3 months
Secondary outcomes:
measure: The average daily inhalation duration per session
timeFrame: Up to 3 months
measure: The average number of daily inhalations
timeFrame: Up to 3 months
measure: Change of sleep quality
timeFrame: Baseline and 3 months
measure: Incidence of AEs
timeFrame: Up to 3 months after first inhalation
measure: Change of heart rate during 6MWD
timeFrame: Baseline and 3 months
measure: The average daily proportion of complete/incomplete inhalations
timeFrame: Up to 3 months
measure: The average association between physical activity level (wearable device based) and time to last inhalation
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many Locations
Study officials:
References:
citation: 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.
citation: 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.