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Completed

NCT Number: NCT03293407

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.

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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Hypertension Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iloprost (Ventavis, BAYQ6256)

Drug

Using Breelib device

Breelib nebulizer

Device

Used for inhalation of Ventavis

Primary outcomes

  1. Change of Six-minute walking distance (6MWD)

    Time frame: Baseline and 3 months

    Clinical outcome measured by study nurse.

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

    Time frame: Baseline and 3 months

  3. Change of Health related Quality of Life-EuroQol five dimensions questionnaire (EQ-5D)

    Time frame: Baseline and 3 months

  4. Change of World Health Organization functional class

    Time frame: Baseline and 3 months

  5. Change of Distance Walked per day

    Time frame: Baseline and 3 months

  6. Change of Number of Steps per day

    Time frame: Baseline and 3 months

  7. Change of number of floors climbed (10 feet) per day

    Time frame: Baseline and 3 months

  8. Change of time spent at home per day

    Time frame: Baseline and 3 months

  9. Change of number of relevant location changes per day

    Time frame: Baseline and 3 months

  10. Change of number of times leaving home per day

    Time frame: Baseline and 3 months

  11. Change of number of times standing up per day

    Time frame: Baseline and 3 months

  12. Change of 6MWD

    Time frame: Baseline and 3 months

    Device based outcome measured by smart device.

  13. Heart rates during baseline and observation period

    Time frame: Up to 3 months

Secondary outcomes

  1. The average daily inhalation duration per session

    Time frame: Up to 3 months

  2. The average number of daily inhalations

    Time frame: Up to 3 months

  3. Change of sleep quality

    Time frame: Baseline and 3 months

    Measured by Pittsburgh Sleep Quality Index (PSQI).

  4. Incidence of AEs

    Time frame: Up to 3 months after first inhalation

  5. Change of heart rate during 6MWD

    Time frame: Baseline and 3 months

  6. The average daily proportion of complete/incomplete inhalations

    Time frame: Up to 3 months

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

    Time frame: Up to 3 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: VENTASTEP

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 26, 2017
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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