Clinical trial NCT01781052: Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients
Official title: DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Keywords: Iloprost Compliance
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-01-31
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Compliance for each subject assessed by the mean daily number of inhalations of Ventavis.
timeFrame: Up to 12 months
Secondary outcomes:
measure: Compliance for each subject assessed by the mean daily number of inhalations of Ventavis
timeFrame: Up to 6 months
measure: Total distance (meters) walked within 6 minutes assessed by the 6 Minutes Walking Distance Test
timeFrame: 6 and 12 months
measure: Dyspnea Borg Category Ration 10 Scale values
timeFrame: 6 and 12 months
measure: Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires)
timeFrame: 6 and 12 months
measure: Investigator and patient satisfaction in the use of I-neb Insight tool assessed by a five level likert scale
timeFrame: Up to 12 months
measure: Population characteristics
timeFrame: At baseline
Other outcomes:
measure: Adverse events
timeFrame: Up to 12 months
Locations:
city: Multiple Locations
country: France
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: