Prospective Multicentre Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension
Overview
- Phase
- Not Applicable
- Intervention
- Iloprost (Ventavis, BAYQ6256)
- Conditions
- Hypertension, Pulmonary
- Sponsor
- Bayer
- Enrollment
- 89
- Primary Endpoint
- Number of missed doses per day as recommended
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Local, prospective, multicenter, non-comparative, non-interventional, observational study. It is planed to assess compliance of patients with PH (pulmonary hypertension) with the physician's recommendation in real practice.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female patients ≥ 18 years old
- •Diagnosis of PH
- •Planned or current treatment with Ventavis (not more than 6 month)
Exclusion Criteria
- •Contraindications for the use of Ventavis in accordance with the local product information
Arms & Interventions
Iloprost
The patients with pulmonary hypertension with inhaled treatment with Ventavis according to routine practice meeting the criteria of inclusion.
Intervention: Iloprost (Ventavis, BAYQ6256)
Outcomes
Primary Outcomes
Number of missed doses per day as recommended
Time Frame: Up to 12 months
Number of days without any drug administration at all
Time Frame: Up to 12 months
Number of fully inhaled doses in relation to the total number of inhalations per day
Time Frame: Up to 12 months
Number of actually inhaled doses per day vs. the recommended number of inhalations - either as recommended by the treating physician or as recommended by the label
Time Frame: Up to 12 months
Secondary Outcomes
- Score on dyspnea Borg CR (category ratio) 10 scale(Up to 12 months)
- Patients' quality of life, assessed by validated questionnaire(Up to 12 months)
- Assessment of lung haemodynamics using the data of echocardiography(Up to 12 months)
- Severity of AEs(Up to 12 months)
- AE relation to treatment(Up to 12 months)
- Assessment of the structural changes in the lungs using X-ray examination of the lungs(Up to 12 months)
- Reason for omission of inhalation as assessed by the physician(Up to 12 months)
- 6 minute walking distance test (MWDT) value(Up to 12 months)
- Assessment of the structural changes in the lungs using spirography(Up to 12 months)
- Concomitant medication for other indications than pulmonary hypertension(Up to 12 months)
- Number of participants with adverse events (AEs)(Up to 12 months)
- AE treatment(Up to 12 months)
- Assessment of lung haemodynamics using the data of catheterization(Up to 12 months)
- AE outcomes(Up to 12 months)