DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients

Bayer0 sites17 target enrollmentSeptember 11, 2013

ConditionsPulmonary Arterial Hypertension

InterventionsVentavis (Iloprost, BAYQ6256)

DrugsVentavis (Iloprost, BAYQ6256)

Overview

Phase: Not Applicable
Intervention: Ventavis (Iloprost, BAYQ6256)
Conditions: Pulmonary Arterial Hypertension
Sponsor: Bayer
Enrollment: 17
Primary Endpoint: Compliance for each subject assessed by the mean daily number of inhalations of Ventavis.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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. 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.

Registry

clinicaltrials.gov

Start Date

September 11, 2013

End Date

January 16, 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Group 1

Intervention: Ventavis (Iloprost, BAYQ6256)

Outcomes

Primary Outcomes

Compliance for each subject assessed by the mean daily number of inhalations of Ventavis.

Time Frame: Up to 12 months

Secondary Outcomes

Investigator and patient satisfaction in the use of I-neb Insight tool assessed by a five level likert scale(Up to 12 months)
Compliance for each subject assessed by the mean daily number of inhalations of Ventavis(Up to 6 months)
Total distance (meters) walked within 6 minutes assessed by the 6 Minutes Walking Distance Test(6 and 12 months)
Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires)(6 and 12 months)
Population characteristics(At baseline)
Dyspnea Borg Category Ration 10 Scale values(6 and 12 months)