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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Drug: Ventavis (Iloprost, BAYQ6256)

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• France
  • Multiple Locations, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compliance for each subject assessed by the mean daily number of inhalations of Ventavis.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Dyspnea Borg Category Ration 10 Scale values		6 and 12 months
Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires)		6 and 12 months
Investigator and patient satisfaction in the use of I-neb Insight tool assessed by a five level likert scale		Up to 12 months
Population characteristics	sociodemography, clinical aspects, risk factors	At baseline

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events	Up to 12 months

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2013
• Primary Completion (Actual): May 26, 2016
• Study Completion (Actual): January 16, 2017

Study Registration Dates

• First Submitted: January 22, 2013
• First Submitted That Met QC Criteria: January 29, 2013
• First Posted (Estimate): January 31, 2013

Study Record Updates

• Last Update Posted (Actual): December 4, 2017
• Last Update Submitted That Met QC Criteria: December 1, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Iloprost Compliance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Vasodilator Agents; Platelet Aggregation Inhibitors; Iloprost
• Other Study ID Numbers: 16133; VE1210FR (Other Identifier: Company internal); 2011/00416 (Other Identifier: Company internal)