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

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Ventavis (Iloprost, BAYQ6256)

• Registration Number: NCT01781052
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-31
• Study Start: 2013-09-11
• Primary Completion: 2016-05-26
• Study Completion: 2017-01-16
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-01
• Last Update Posted: 2017-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Ventavis (Iloprost, BAYQ6256)	-

Primary Outcome Measures

Name	Time	Method
Compliance for each subject assessed by the mean daily number of inhalations of Ventavis.	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
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	sociodemography, clinical aspects, risk factors
Dyspnea Borg Category Ration 10 Scale values	6 and 12 months