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

Pulmonary Arterial Hypertension Clinical Trial

— DAILY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781052
• Other study ID #: 16133
• Secondary ID: VE1210FR2011/004
• Status: Completed
• Phase: N/A
• First received: January 22, 2013
• Last updated: December 1, 2017
• Start date: September 11, 2013
• Est. completion date: January 16, 2017

Study information

• Verified date: December 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 16, 2017
• Est. primary completion date: May 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events		Up to 12 months
Primary	Compliance for each subject assessed by the mean daily number of inhalations of Ventavis.		Up to 12 months
Secondary	Compliance for each subject assessed by the mean daily number of inhalations of Ventavis		Up to 6 months
Secondary	Total distance (meters) walked within 6 minutes assessed by the 6 Minutes Walking Distance Test		6 and 12 months
Secondary	Dyspnea Borg Category Ration 10 Scale values		6 and 12 months
Secondary	Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires)		6 and 12 months
Secondary	Investigator and patient satisfaction in the use of I-neb Insight tool assessed by a five level likert scale		Up to 12 months
Secondary	Population characteristics	sociodemography, clinical aspects, risk factors	At baseline

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