check_circleStudy Completed
Hypertension, Pulmonary
Bayer Identifier:
19398
ClinicalTrials.gov Identifier:
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.
The study was not designed to investigate or confirm the effectiveness and safety of iloprost.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
31Trial Dates
February 2018 - January 2020Phase
Phase 4Could I Receive a placebo
NoProducts
Ventavis (Iloprost, BAYQ6256)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations | Many 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/BNPdate_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 classdate_rangeTime Frame:Baseline and 3 months
- Change of Distance Walked per daydate_rangeTime Frame:Baseline and 3 months
- Change of Number of Steps per daydate_rangeTime Frame:Baseline and 3 months
- Change of number of floors climbed (10 feet) per daydate_rangeTime Frame:Baseline and 3 months
- Change of time spent at home per daydate_rangeTime Frame:Baseline and 3 months
- Change of number of relevant location changes per daydate_rangeTime Frame:Baseline and 3 months
- Change of number of times leaving home per daydate_rangeTime Frame:Baseline and 3 months
- Change of number of times standing up per daydate_rangeTime Frame:Baseline and 3 months
- Change of 6MWDDevice based outcome measured by smart device.date_rangeTime Frame:Baseline and 3 months
- Heart rates during baseline and observation perioddate_rangeTime Frame:Up to 3 months
Secondary Outcome
- The average daily inhalation duration per sessiondate_rangeTime Frame:Up to 3 months
- The average number of daily inhalationsdate_rangeTime Frame:Up to 3 months
- Change of sleep qualityMeasured by Pittsburgh Sleep Quality Index (PSQI).date_rangeTime Frame:Baseline and 3 months
- Incidence of AEsdate_rangeTime Frame:Up to 3 months after first inhalation
- Change of heart rate during 6MWDdate_rangeTime Frame:Baseline and 3 months
- The average daily proportion of complete/incomplete inhalationsdate_rangeTime Frame:Up to 3 months
- The average association between physical activity level (wearable device based) and time to last inhalationdate_rangeTime Frame:Up to 3 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A