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

Completed

• Conditions: Hypertension, Pulmonary
• Interventions: Drug: Iloprost (Ventavis, BAYQ6256); Device: Breelib nebulizer

• Registration Number: NCT03293407
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-26
• Study Start: 2018-02-01
• Primary Completion: 2019-10-09
• Study Completion: 2020-01-20
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-25
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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Exclusion Criteria

• Patients allergic to Nickel and Methacrylates
• Patients participating in an investigational program with interventions outside of routine clinical practice

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BAYQ6256_Ventavis	Breelib nebulizer	Patients with pulmonary hypertension who agree to be treated with Ventavis (Iloprost) at the discretion of physician
BAYQ6256_Ventavis	Iloprost (Ventavis, BAYQ6256)	Patients with pulmonary hypertension who agree to be treated with Ventavis (Iloprost) at the discretion of physician

Primary Outcome Measures

Name	Time	Method
Change of laboratory results of the biomarkers NT-pro BNP/BNP	Baseline and 3 months
Change of World Health Organization functional class	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 times standing up per day	Baseline and 3 months
Change of 6MWD	Baseline and 3 months	Device based outcome measured by smart device.
Change of Six-minute walking distance (6MWD)	Baseline and 3 months	Clinical outcome measured by study nurse.
Change of number of relevant location changes per day	Baseline and 3 months
Change of Distance Walked per day	Baseline and 3 months
Change of Health related Quality of Life-EuroQol five dimensions questionnaire (EQ-5D)	Baseline and 3 months
Change of number of times leaving home per day	Baseline and 3 months
Heart rates during baseline and observation period	Up to 3 months

Secondary Outcome Measures

Name	Time	Method
Change of heart rate during 6MWD	Baseline and 3 months
Change of sleep quality	Baseline and 3 months	Measured by Pittsburgh Sleep Quality Index (PSQI).
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
The average association between physical activity level (wearable device based) and time to last inhalation	Up to 3 months

Trial Locations

Locations (1)

Many Locations; 🇩🇪 Multiple Locations, Germany