This pilot, non-interventional, company-sponsored, multi-center study documents observational data on patients under routine treatment of Pulmonary Arterial Hypertension (PAH) with inhaled iloprost (using I-Neb device for the inhalation). The planned study recruitment time is 18 months. The maximum follow up period in this study will be 12 months. The data will be collected from patients who have initiated the treatment mentioned above (inhaled iloprost using I-Neb device) since February 1st, 2013. Frequency of visits and procedures will be performed under routine conditions. The primary objective of this study is to assess the compliance of patients with WHO/NYHA (World Health Organization/New York Heart Association) functional Class III Pulmonary Arterial Hypertension treated with Inhaled Iloprost in clinical practice, using the I-neb Insight tool.
Study Type
OBSERVATIONAL
Enrollment
13
Patients Diagnosed with Pulmonary Arterial Hypertension, Functional Class NYHA/WHO III, for whom was prescribed inhaled Iloprost.
Unnamed facility
Multiple Locations, Portugal
Percentage of compliant patients
The compliance will be assessed by the mean daily number of Inhalations and mean daily dose of Ventavis at around months 6 and 12 for each patient (Data will be collected via the I-neb Insight). For this observational study, a patient is considered compliant if the mean daily number of inhalations and mean daily dose are within 80 to 120% of prescribed. Otherwise, the patient will be considered as non-compliant.
Time frame: Up to 12 months
Observed treatment duration days
Time frame: Up to 12 months
Expected treatment duration days
Time frame: Up to 12 months
Changes in WHO/ NYHA Functional Class
Time frame: Up to 12 months
Change in 6 MWDT (6 minute walking distance test) scale value
Time frame: Up to 12 months
Change in Dyspnea Borg CR (category ratio) 10 scale value
Time frame: Up to 12 months
Quality of life using validated scales (EuroQol questionnaire [EQ-5D], Living with Pulmonary Hypertension questionnaire [LPH])
Time frame: Up to 12 months
Adjusted percentage treatment duration
Time frame: Up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.