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

Ventavis® (Iloprost): Evaluation of Inhaled Iloprost Effects Using the Breelib™ Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension

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 Overview

• Status: Completed
• Conditions: Hypertension, Pulmonary
• Intervention / Treatment: Drug: Iloprost (Ventavis, BAYQ6256); Device: Breelib nebulizer

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Germany
  • Multiple Locations, Germany
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BAYQ6256_Ventavis; Patients with pulmonary hypertension who agree to be treated with Ventavis (Iloprost) at the discretion of physician	Drug: Iloprost (Ventavis, BAYQ6256); Using Breelib device; Device: Breelib nebulizer; Used for inhalation of Ventavis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Six-minute walking distance (6MWD)	Clinical outcome measured by study nurse.	Baseline and 3 months
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	Device based outcome measured by smart device.	Baseline and 3 months
Heart rates during baseline and observation period		Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measured by Pittsburgh Sleep Quality Index (PSQI).	Baseline and 3 months
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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General 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.
• 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.

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): October 9, 2019
• Study Completion (Actual): January 20, 2020

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Pulmonary arterial hypertension; PAH
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Vasodilator Agents; Platelet Aggregation Inhibitors; Iloprost
• Other Study ID Numbers: 19398

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No