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

Bayer31 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hypertension, Pulmonary

Interventions

Iloprost (Ventavis, BAYQ6256)DRUG

Using Breelib device

Breelib nebulizerDEVICE

Used for inhalation of Ventavis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Many Locations

Multiple Locations, Germany

Outcomes

Primary Outcomes

Change of Six-minute walking distance (6MWD)

Clinical outcome measured by study nurse.

Time frame: Baseline and 3 months

Change of laboratory results of the biomarkers NT-pro BNP/BNP

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 World Health Organization functional class

Time frame: Baseline and 3 months

Change of Distance Walked per day

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 relevant location changes per day

Time frame: Baseline and 3 months

Change of number of times leaving 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

Data from ClinicalTrials.gov

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Secondary Outcomes

The average daily inhalation duration per session

Time frame: Up to 3 months

The average number of daily inhalations

Time frame: Up to 3 months

Change of sleep quality

Measured by Pittsburgh Sleep Quality Index (PSQI).

Time frame: Baseline and 3 months

Incidence of AEs

Time frame: Up to 3 months after first inhalation

Change of heart rate during 6MWD

Time frame: Baseline and 3 months

The average daily proportion of complete/incomplete inhalations

Time frame: Up to 3 months

The average association between physical activity level (wearable device based) and time to last inhalation

Time frame: Up to 3 months