Overview

This trial is active, not recruiting.

Condition pulmonary arterial hypertension
Treatment ventavis (iloprost, bayq6256)
Sponsor Bayer
Start date September 2013
End date May 2016
Trial size 17 participants
Trial identifier NCT01781052, 16133, 2011/00416, VE1210FR

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.