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

NCT01781052 | Completed

• 3 other identifiers: 16133VE1210FR2011/00416
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Iloprost Compliance

Outcome Measures

Primary Outcomes (1)

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

  Up to 12 months

Secondary Outcomes (6)

• 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

Other Outcomes (1)

• Adverse events

  Up to 12 months

Study Arms (1)

Group 1

Drug: Ventavis (Iloprost, BAYQ6256)

Interventions

Ventavis (Iloprost, BAYQ6256) DRUG

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.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, France

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 31, 2013
• Study Start: September 11, 2013
• Primary Completion: May 26, 2016
• Study Completion: January 16, 2017
• Last Updated: December 4, 2017

Record last verified: 2017-12

Locations

FR (1)