Hypertension, PulmonaryVENTASTEPNCT03293407
Evaluation of Inhaled Iloprost Effects Using the Breelib Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension
An observational study of Hypertension, Pulmonary, run by Bayer at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Iloprost (Ventavis, BAYQ6256) and Breelib nebulizer
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2018to 20 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Patients allergic to Nickel and Methacrylates
- Patients participating in an investigational program with interventions outside of routine clinical practice
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Iloprost (Ventavis, BAYQ6256), Breelib nebulizer
- Keywords
- Pulmonary arterial hypertension, PAH
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iloprost (Ventavis, BAYQ6256)Drug
Using Breelib device
Breelib nebulizerDevice
Used for inhalation of Ventavis
| Study group | Role | What they receive |
|---|---|---|
| BAYQ6256_Ventavis | Patients with pulmonary hypertension who agree to be treated with Ventavis (Iloprost) at the discretion of physician Receives: Drug: Iloprost (Ventavis, BAYQ6256); Device: Breelib nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Six-minute walking distance (6MWD)
Clinical outcome measured by study nurse.
Measured: Baseline and 3 months
Change of laboratory results of the biomarkers NT-pro BNP/BNP
Measured: Baseline and 3 months
Change of Health related Quality of Life-EuroQol five dimensions questionnaire (EQ-5D)
Measured: Baseline and 3 months
Change of World Health Organization functional class
Measured: Baseline and 3 months
Change of Distance Walked per day
Measured: Baseline and 3 months
Change of Number of Steps per day
Measured: Baseline and 3 months
Change of number of floors climbed (10 feet) per day
Measured: Baseline and 3 months
Change of time spent at home per day
Measured: Baseline and 3 months
Change of number of relevant location changes per day
Measured: Baseline and 3 months
Change of number of times leaving home per day
Measured: Baseline and 3 months
Change of number of times standing up per day
Measured: Baseline and 3 months
Change of 6MWD
Device based outcome measured by smart device.
Measured: Baseline and 3 months
Heart rates during baseline and observation period
Measured: Up to 3 months
Secondary outcomes (7)
The average daily inhalation duration per session
Measured: Up to 3 months
The average number of daily inhalations
Measured: Up to 3 months
Change of sleep quality
Measured by Pittsburgh Sleep Quality Index (PSQI).
Measured: Baseline and 3 months
Incidence of AEs
Measured: Up to 3 months after first inhalation
Change of heart rate during 6MWD
Measured: Baseline and 3 months
The average daily proportion of complete/incomplete inhalations
Measured: Up to 3 months
The average association between physical activity level (wearable device based) and time to last inhalation
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start1 Feb 2018
- Primary completion9 Oct 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293407
- Sponsor's protocol ID
- 19398
- Acronym
- VENTASTEP
- Status last verified
- May 2021
- First submitted
- 20 Sep 2017
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mueller C, Stollfuss B, Roitenberg A, Harder J, Richter MJ. Evaluation of Clinical Outcomes and Simultaneous Digital Tracking of Daily Physical Activity, Heart Rate, and Inhalation Behavior in Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost: Protocol for the Observational VENTASTEP Study. JMIR Res Protoc. 2019 Apr 15;8(4):e12144. doi: 10.2196/12144.
PubMed 30985279Stollfuss B, Richter M, Dromann D, Klose H, Schwaiblmair M, Gruenig E, Ewert R, Kirchner MC, Kleinjung F, Irrgang V, Mueller C. Digital Tracking of Physical Activity, Heart Rate, and Inhalation Behavior in Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost: Observational Study (VENTASTEP). J Med Internet Res. 2021 Oct 8;23(10):e25163. doi: 10.2196/25163.
PubMed 34623313
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03293407
- Acronym / sponsor ID
- VENTASTEP / 19398
- Conditions
- Hypertension, Pulmonary
- Keywords
- Pulmonary arterial hypertension, PAH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAYQ6256_Ventavis | – | Drug: Iloprost (Ventavis, BAYQ6256), Device: Breelib nebulizerPatients with pulmonary hypertension who agree to be treated with Ventavis (Iloprost) at the discretion of physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients allergic to Nickel and Methacrylates
- Patients participating in an investigational program with interventions outside of routine clinical practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iloprost (Ventavis, BAYQ6256)Using Breelib device | Drug | BAYQ6256_Ventavis |
| Breelib nebulizerUsed for inhalation of Ventavis | Device | BAYQ6256_Ventavis |
Primary outcome
Change of Six-minute walking distance (6MWD)
Time frame: Baseline and 3 months
Clinical outcome measured by study nurse.
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
Time frame: Baseline and 3 months
Device based outcome measured by smart device.
Heart rates during baseline and observation period
Time frame: Up to 3 months
7 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Background: PubMed 30985279Mueller C, Stollfuss B, Roitenberg A, Harder J, Richter MJ. Evaluation of Clinical Outcomes and Simultaneous Digital Tracking of Daily Physical Activity, Heart Rate, and Inhalation Behavior in Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost: Protocol for the Observational VENTASTEP Study. JMIR Res Protoc. 2019 Apr 15;8(4):e12144. doi: 10.2196/12144.
- Derived from this study: PubMed 34623313Stollfuss B, Richter M, Dromann D, Klose H, Schwaiblmair M, Gruenig E, Ewert R, Kirchner MC, Kleinjung F, Irrgang V, Mueller C. Digital Tracking of Physical Activity, Heart Rate, and Inhalation Behavior in Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost: Observational Study (VENTASTEP). J Med Internet Res. 2021 Oct 8;23(10):e25163. doi: 10.2196/25163.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, Pulmonary, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Six-minute walking distance (6MWD) (time frame: Baseline and 3 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03293407, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.