An observational study in Hypertension, Pulmonary, sponsored by Bayer. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-26.
Sponsored by Bayer · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 19 studies in Pulmonary Arterial Hypertension by Bayer — none open to participants now, 1 under way, 1 of them phase 3. Pulmonary Arterial Hypertension · Bayer.
Among the 19 studies in Pulmonary Arterial Hypertension by Bayer, this one is the 11th largest by enrollment of the 12 observational ones that give a count, is the only one that started in 2018, is one of 12 observational ones, and was the 16th registered.
699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.
Browse Pulmonary Arterial Hypertension studies →None of the 19 studies in Pulmonary Arterial Hypertension by Bayer is open now. The open studies under Pulmonary Arterial Hypertension, anywhere →
Of the 90 Pulmonary Arterial Hypertension studies recruiting now, 51 (57%) set no upper age limit and 24 (27%) stop at 75 or younger; 18 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 3 · Phase 4 1
First in 2007; this study’s year is marked. 1 started in 2018.
This study's enrollment of 31 is below the median of 104 across 181 observational studies indexed under Pulmonary Arterial Hypertension.
Median enrollment 75 across the 7 interventional studies, 84 across the 12 observational. Of the 18 that completed or were terminated, 3 (17%) have results posted.
This tab as a report to print or save as PDF → With an account.
Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 19 studies in Pulmonary Arterial Hypertension by Bayer, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.
This study's enrollment of 31 is below the median of 104 across 181 observational studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
Compared within Pulmonary Arterial Hypertension, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypertension, Pulmonary. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients with pulmonary hypertension at intermediate risk and WHO FC III who failed to respond adequately to initial therapy with one or more PAH drugs or who clinically deteriorated after initial treatment response and for whom a therapy escalation with Ventavis (Iloprost) has been agreed by patient and physician.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with pulmonary hypertension who agree to be treated with Ventavis (Iloprost) at the discretion of physician
Drug: Iloprost (Ventavis, BAYQ6256) · Device: Breelib nebulizer
Using Breelib device
Used for inhalation of Ventavis
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
Device based outcome measured by smart device.
Time frame: Baseline and 3 months
Heart rates during baseline and observation period
Time frame: Up to 3 months
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
Ran from Feb 2018 to primary completion in Oct 2019, 20 months.
Of 85 observational studies under Pulmonary Arterial Hypertension, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 93. This study's 20 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Arterial Hypertension →