Hypertension, PulmonaryVENTASWITCHNCT02826252
Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20)
An observational study of Hypertension, Pulmonary, run by Bayer at 1 site in Germany.
Trial summary
The aim of this study is to examine inhalation behavior in patients enrolled in the German Ventavis patient support program Ventaplus when these patients are switched from Ventavis (Iloprost) 10 μg/mL to Ventavis (Iloprost) 20 μg/mL formulation. 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 I-Neb AAD system
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- 15 Sep 2016to 24 Jan 2017
- 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: The study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus which is executed for Bayer by the company Contra Care GmbH, Nürnberg. Patients who are enrolled in the program and repeatedly experienced extended inhalation times with Ventavis (Iloprost) 10 μg/mL which could possibly result in incomplete inhalations, are currently being switched to Ventavis (Iloprost) 20 μg/mL by their physician.
Who may be able to join
- Patients aged ≥18 years at time of signing informed consent.
- Patients, diagnosed with group 1 PAH.
- Patients must be enrolled in the German Ventavis patient support program Ventaplus.
- Patients who either already switched from V10 to V20 therapy or who agreed to do so according to their physician's decision.
- Patients must have been on V10 therapy for at least 2 weeks.
- Written informed consent must be obtained.
Who cannot join
- participation in other clinical or interventional study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VENTASWITCH, Examination of Ventavis® (Iloprost) Inhalation Behavior Using the I-Neb® AAD® System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20)
The aim of this study is to examine inhalation behavior in patients enrolled in the German Ventavis patient support program Ventaplus when these patients are switched from Ventavis (Iloprost) 10 μg/mL to Ventavis (Iloprost) 20 μg/mL formulation.
Read the detailed description
The VENTASWITCH study will be a local, prospective and retrospective, observational, case-crossover study. Data are collected and downloaded from the I-Neb AAD (Adaptive Aerosol Delivery) System. Two data collection periods are planned: period one; data collection from the last 3 months using Ventavis (Iloprost) 10 μg/mL (V10) before the index date of switching to Ventavis (Iloprost) 20 μg/mL (V20) (retrospective part) and period two; data collection for 3 months using V20 from index date (prospective part).
- Conditions
- Hypertension, Pulmonary
- Being tested
- Iloprost,(Ventavis, BAYQ6256), I-Neb AAD system
- 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
Ventavis (Iloprost) nebulizer solution for inhalation as 10 μg/mL (V10) and 20 μg/mL (V20).
I-Neb AAD systemDevice
Nebulizer, allows digital recording of inhalation data such as doses, inhalations per day and duration of inhalation (per day) etc.
| Study group | Role | What they receive |
|---|---|---|
| Ventavis | The study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus. Receives: Drug: Iloprost,(Ventavis, BAYQ6256); Device: I-Neb AAD system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of inhalations on Iloprost 10 ug/mL and 20 ug/mL
Measured: Up to 6 months
Number of delivered doses (none/partial/full) on Iloprost 10 ug/mL and 20 ug/mL
Measured: Up to 6 months
Secondary outcomes (1)
Inhalation durations (min) per session on Iloprost 10 ug/mL and 20 ug/mL
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start15 Sep 2016
- Primary completion15 Nov 2016
- Study completion24 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case crossover
- Time perspective
- Other
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826252
- Sponsor's protocol ID
- 18838
- Acronym
- VENTASWITCH
- Status last verified
- Mar 2017
- First submitted
- 5 Jul 2016
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VENTASWITCH, Examination of Ventavis® (Iloprost) Inhalation Behavior Using the I-Neb® AAD® System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20)
- ClinicalTrials.gov ID
- NCT02826252
- Acronym / sponsor ID
- VENTASWITCH / 18838
- Conditions
- Hypertension, Pulmonary
- Keywords
- Pulmonary Arterial Hypertension (PAH)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 24 Jan 2017 (actual)
- First posted
- 7 Jul 2016 (estimated)
- 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 aim of this study is to examine inhalation behavior in patients enrolled in the German Ventavis patient support program Ventaplus when these patients are switched from Ventavis (Iloprost) 10 μg/mL to Ventavis (Iloprost) 20 μg/mL formulation.
Detailed description
The VENTASWITCH study will be a local, prospective and retrospective, observational, case-crossover study. Data are collected and downloaded from the I-Neb AAD (Adaptive Aerosol Delivery) System. Two data collection periods are planned: period one; data collection from the last 3 months using Ventavis (Iloprost) 10 μg/mL (V10) before the index date of switching to Ventavis (Iloprost) 20 μg/mL (V20) (retrospective part) and period two; data collection for 3 months using V20 from index date (prospective part).
Study design
- Observational model
- Case crossover
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventavis | – | Drug: Iloprost,(Ventavis, BAYQ6256), Device: I-Neb AAD systemThe study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus which is executed for Bayer by the company Contra Care GmbH, Nürnberg. Patients who are enrolled in the program and repeatedly experienced extended inhalation times with Ventavis (Iloprost) 10 μg/mL which could possibly result in incomplete inhalations, are currently being switched to Ventavis (Iloprost) 20 μg/mL by their physician.
Key inclusion criteria (6 listed)
- Patients aged ≥18 years at time of signing informed consent.
- Patients, diagnosed with group 1 PAH.
- Patients must be enrolled in the German Ventavis patient support program Ventaplus.
- Patients who either already switched from V10 to V20 therapy or who agreed to do so according to their physician's decision.
- Patients must have been on V10 therapy for at least 2 weeks.
Key exclusion criteria (1 listed)
- participation in other clinical or interventional study.
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)Ventavis (Iloprost) nebulizer solution for inhalation as 10 μg/mL (V10) and 20 μg/mL (V20). | Drug | Ventavis |
| I-Neb AAD systemNebulizer, allows digital recording of inhalation data such as doses, inhalations per day and duration of inhalation (per day) etc. | Device | Ventavis |
Primary outcome
Number of inhalations on Iloprost 10 ug/mL and 20 ug/mL
Time frame: Up to 6 months
Number of delivered doses (none/partial/full) on Iloprost 10 ug/mL and 20 ug/mL
Time frame: Up to 6 months
1 secondary outcome
Inhalation durations (min) per session on Iloprost 10 ug/mL and 20 ug/mL
Time frame: Up to 6 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 15 Mar 2017.
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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.
Bayer Study Director study director
Bayer
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 6 inclusion and 1 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 15 Mar 2017. 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?
Number of inhalations on Iloprost 10 ug/mL and 20 ug/mL (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2017.