Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients (DAILY)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pulmonary Arterial Hypertension |
Drug: Ventavis (Iloprost, BAYQ6256) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients |
- Compliance of Ventavis use for each subject assessed by the mean daily number of inhalations and mean daily dose of Ventavis. [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
- Compliance of Ventavis use for each subject assessed by the mean daily number of inhalations and mean daily dose of Ventavis [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
- Total distance (meters) walked within 6 minutes assessed by the 6 Minutes Walking Distance Test [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- Dyspnea Borg Category Ration 10 Scale values [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Group 1 |
Drug: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
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;
- 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
Contacts and Locations| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
| France | |
| Not yet recruiting | |
| Many Locations, France | |
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT01781052 History of Changes |
| Other Study ID Numbers: | 16133, VE1210FR, 2011/00416 |
| Study First Received: | January 22, 2013 |
| Last Updated: | May 8, 2013 |
| Health Authority: | France: none |
Keywords provided by Bayer:
|
Iloprost Compliance |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases Iloprost |
Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Vasodilator Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013