Pulmonary Arterial HypertensionDAILYNCT01781052
Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients
An observational study of Pulmonary Arterial Hypertension, run by Bayer at 1 site in France.
Trial summary
This prospective, non-interventional, multi-center study documents observational data on subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Ventavis (Iloprost, BAYQ6256)
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2013to 16 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: Patients aged ≥18 years and diagnosed with PAH (Pulmonary Arterial Hypertension), WHO/NYHA functional class III, Group I of the Dana point Pulmonary Hypertension Classification and newly Treated with Ventavis or treated with Ventavis for less than 6 months, with I-Neb AAD device for the application.
Who may be able to join
- Male or female subjects aged ≥18 years
- Newly Treated with Ventavis or treated with Ventavis for less than 6 months, with I Neb AAD device for the application, as described in the SmPC (Summary of Product Characteristics), complemented by the Insight
- With Pulmonary Arterial Hypertension, Group I of the Dana point Pulmonary Hypertension Classification.
- WHO (World Health Organization) /NYHA (New York Heart Association) Functional class III
- Able and willing to give written informed consent for participation in the study
Who cannot join
- Key contra indications:
- Hypersensitivity to the active substance or to any of the excipients.
- Conditions where the effects of Ventavis on platelets might increase the risk of haemorrhage (e.g. active peptic ulcers, trauma, intracranial haemorrhage).
- Severe coronary heart disease or unstable angina;
- Myocardial infarction within the last six months;
- Decompensated cardiac failure if not under close medical supervision;
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- Severe arrhythmias;
- Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months.
- Pulmonary hypertension due to venous occlusive disease.
- Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients
This prospective, non-interventional, multi-center study documents observational data on subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The observation period for each subject covers a one year treatment period with inhaled Ventavis. For each subject, the investigator or a delegate collects data as defined in the case report form at an initial visit, routine follow-up visit at 6 months and final visit at 12 months.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Ventavis (Iloprost, BAYQ6256)
- Keywords
- Iloprost Compliance
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventavis (Iloprost, BAYQ6256)Drug
Initial dose: 2.5 µg per inhalation session; 6-9 inhalations/day. Dose can be increased to up to 5.0 µg per inhalation session.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Ventavis (Iloprost, BAYQ6256) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance for each subject assessed by the mean daily number of inhalations of Ventavis.
Measured: Up to 12 months
Secondary outcomes (6)
Compliance for each subject assessed by the mean daily number of inhalations of Ventavis
Measured: Up to 6 months
Total distance (meters) walked within 6 minutes assessed by the 6 Minutes Walking Distance Test
Measured: 6 and 12 months
Dyspnea Borg Category Ration 10 Scale values
Measured: 6 and 12 months
Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires)
Measured: 6 and 12 months
Investigator and patient satisfaction in the use of I-neb Insight tool assessed by a five level likert scale
Measured: Up to 12 months
Population characteristics
sociodemography, clinical aspects, risk factors
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study start11 Sep 2013
- Primary completion26 May 2016
- Study completion16 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies 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
- 17 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
- NCT01781052
- Sponsor's protocol ID
- 16133
- Other IDs
- VE1210FR, 2011/00416
- Acronym
- DAILY
- Status last verified
- Dec 2017
- First submitted
- 22 Jan 2013
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients
- ClinicalTrials.gov ID
- NCT01781052
- Acronym / sponsor ID
- DAILY / 16133
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Iloprost Compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2013 (actual)
- Primary completion
- 26 May 2016 (actual)
- Study completion
- 16 Jan 2017 (actual)
- First posted
- 31 Jan 2013 (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.
This prospective, non-interventional, multi-center study documents observational data on subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The observation period for each subject covers a one year treatment period with inhaled Ventavis. For each subject, the investigator or a delegate collects data as defined in the case report form at an initial visit, routine follow-up visit at 6 months and final visit at 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Ventavis (Iloprost, BAYQ6256) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥18 years and diagnosed with PAH (Pulmonary Arterial Hypertension), WHO/NYHA functional class III, Group I of the Dana point Pulmonary Hypertension Classification and newly Treated with Ventavis or treated with Ventavis for less than 6 months, with I-Neb AAD device for the application.
Key inclusion criteria (5 listed)
- Male or female subjects aged ≥18 years
- Newly Treated with Ventavis or treated with Ventavis for less than 6 months, with I Neb AAD device for the application, as described in the SmPC (Summary of Product Characteristics), complemented by the Insight
- With Pulmonary Arterial Hypertension, Group I of the Dana point Pulmonary Hypertension Classification.
- WHO (World Health Organization) /NYHA (New York Heart Association) Functional class III
- Able and willing to give written informed consent for participation in the study
Key exclusion criteria (10 listed)
- Hypersensitivity to the active substance or to any of the excipients.
- Conditions where the effects of Ventavis on platelets might increase the risk of haemorrhage (e.g. active peptic ulcers, trauma, intracranial haemorrhage).
- Severe coronary heart disease or unstable angina;
- Myocardial infarction within the last six months;
- Decompensated cardiac failure if not under close medical supervision;
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 |
|---|---|---|
| Ventavis (Iloprost, BAYQ6256)Initial dose: 2.5 µg per inhalation session; 6-9 inhalations/day. Dose can be increased to up to 5.0 µg per inhalation session. | Drug | Group 1 |
Primary outcome
Compliance for each subject assessed by the mean daily number of inhalations of Ventavis.
Time frame: Up to 12 months
6 secondary outcomes
Compliance for each subject assessed by the mean daily number of inhalations of Ventavis
Time frame: Up to 6 months
Total distance (meters) walked within 6 minutes assessed by the 6 Minutes Walking Distance Test
Time frame: 6 and 12 months
Dyspnea Borg Category Ration 10 Scale values
Time frame: 6 and 12 months
Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires)
Time frame: 6 and 12 months
Investigator and patient satisfaction in the use of I-neb Insight tool assessed by a five level likert scale
Time frame: Up to 12 months
Population characteristics
Time frame: At baseline
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 4 Dec 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 Pulmonary Arterial Hypertension, run by Bayer at 1 site in France.
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 5 inclusion and 10 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 4 Dec 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 France. 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?
Compliance for each subject assessed by the mean daily number of inhalations of Ventavis. (time frame: Up to 12 months). 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 4 Dec 2017.