check_circleStudy Completed

Hypertension, Pulmonary

Bayer Identifier:

19398

ClinicalTrials.gov Identifier:

NCT03293407

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of inhaled iloprost effects using the Breelib nebulizer, on clinical outcomes and physical activity of patients with advanced pulmonary arterial hypertension

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • - Patients allergic to Nickel and Methacrylates
    - Patients participating in an investigational program with interventions outside of routine clinical practice

Trial summary

Enrollment Goal
31
Trial Dates
February 2018 - January 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Germany

Primary Outcome

  • Change of Six-minute walking distance (6MWD)
    Clinical outcome measured by study nurse.
    date_rangeTime Frame:
    Baseline and 3 months
  • Change of laboratory results of the biomarkers NT-pro BNP/BNP
    date_rangeTime Frame:
    Baseline and 3 months
  • Change of Health related Quality of Life-EuroQol five dimensions questionnaire (EQ-5D)
    date_rangeTime Frame:
    Baseline and 3 months
  • Change of World Health Organization functional class
    date_rangeTime Frame:
    Baseline and 3 months
  • Change of Distance Walked per day
    date_rangeTime Frame:
    Baseline and 3 months
  • Change of Number of Steps per day
    date_rangeTime Frame:
    Baseline and 3 months
  • Change of number of floors climbed (10 feet) per day
    date_rangeTime Frame:
    Baseline and 3 months
  • Change of time spent at home per day
    date_rangeTime Frame:
    Baseline and 3 months
  • Change of number of relevant location changes per day
    date_rangeTime Frame:
    Baseline and 3 months
  • Change of number of times leaving home per day
    date_rangeTime Frame:
    Baseline and 3 months
  • Change of number of times standing up per day
    date_rangeTime Frame:
    Baseline and 3 months
  • Change of 6MWD
    Device based outcome measured by smart device.
    date_rangeTime Frame:
    Baseline and 3 months
  • Heart rates during baseline and observation period
    date_rangeTime Frame:
    Up to 3 months

Secondary Outcome

  • The average daily inhalation duration per session
    date_rangeTime Frame:
    Up to 3 months
  • The average number of daily inhalations
    date_rangeTime Frame:
    Up to 3 months
  • Change of sleep quality
    Measured by Pittsburgh Sleep Quality Index (PSQI).
    date_rangeTime Frame:
    Baseline and 3 months
  • Incidence of AEs
    date_rangeTime Frame:
    Up to 3 months after first inhalation
  • Change of heart rate during 6MWD
    date_rangeTime Frame:
    Baseline and 3 months
  • The average daily proportion of complete/incomplete inhalations
    date_rangeTime Frame:
    Up to 3 months
  • The average association between physical activity level (wearable device based) and time to last inhalation
    date_rangeTime Frame:
    Up to 3 months

Trial design

Ventavis® (Iloprost): Evaluation of inhaled iloprost effects using the Breelib™ nebulizer, on clinical outcomes and physical activity of patients with advanced pulmonary arterial hypertension
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here to find results for studies related to Bayer products