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 Type
OBSERVATIONAL
Enrollment
17
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.
Unnamed facility
Multiple Locations, France
Compliance for each subject assessed by the mean daily number of inhalations of Ventavis.
Time frame: Up to 12 months
Compliance for each subject assessed by the mean daily number of inhalations 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
Population characteristics
sociodemography, clinical aspects, risk factors
Time frame: At baseline
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