Trial Condition(s):
Hypertension, Pulmonary
Examination of Ventavis (Iloprost) inhalation behavior using the I-Neb AAD system in patients with pulmonary arterial hypertension when switching the Iloprost nebulizer solution for inhalation from 10 μg/mL (V10) to 20 μg/mL (V20) (VENTASWITCH)
Bayer Identifier:
18838
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The aim of this study is to examine inhalation behavior in patients enrolled in the German Ventavis patient support program Ventaplus when these patients are switched from Ventavis (Iloprost) 10 μg/mL to Ventavis (Iloprost) 20 μg/mL formulation.
Inclusion Criteria
- Patients aged ≥18 years at time of signing informed consent. - Patients, diagnosed with group 1 PAH. - Patients must be enrolled in the German Ventavis patient support program Ventaplus. - Patients who either already switched from V10 to V20 therapy or who agreed to do so according to their physician’s decision. - Patients must have been on V10 therapy for at least 2 weeks. - Written informed consent must be obtained.
Exclusion Criteria
- participation in other clinical or interventional study.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many locations, Germany | Status Completed | Contact Us: E-mail: clinical-[email protected] Phone: Not Available |
Trial Design
VENTASWITCH, Examination of Ventavis® (Iloprost) inhalation behavior using the I-Neb® AAD® system in patients with pulmonary arterial hypertension when switching the Iloprost nebulizer solution for inhalation from 10 μg/mL (V10) to 20 μg/mL (V20)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Inhalation frequencies on Iloprost 10 ug/mL and 20 ug/mLTimeframe: Up to 6 months
- Session-wise doses delivered (none/partial/full) on Iloprost 10 ug/mL and 20 ug/mLTimeframe: Up to 6 months
Secondary Outcome
- Inhalation durations (min) per session on Iloprost 10 ug/mL and 20 ug/mLTimeframe: Up to 6 months
Additional Information
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