Ventavis® Registry Protocol

Study Overview
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Brief Summary
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The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. Data will be collected via patient interview and review of the medical record. Quarterly data collection will include capture of medications and Ventavis® adherence data.

Detailed Description
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The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH and who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. All data will be collected via patient interview and/or review of the medical record, as well as from I-neb® downloads using INSIGHT software. Adherence with Ventavis® will be compared before and after targeted instruction on inhalation techniques by a respiratory therapist or designee, as well as before and after participation in PAH patient support groups (if applicable). Quarterly data collection will include capture of PAH and non-PAH medications and Ventavis® adherence data; Ventavis® adherence data will also be collected one month after study entry.

Official Title
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Registry to Prospectively Evaluate Use of Ventavis® in Patients With Pulmonary Arterial Hypertension

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Drug: Commercial Ventavis® (iloprost)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a current diagnosis of WHO Group I PAH Have initiated therapy with commercial Ventavis® administered via portable nebulizer at least 3 months prior to study enrollment, either with commercial product or from participation in Actelion's Clinical Study AC-063A302 Age > or = 18 years old at the time of enrollment Exclusion Criteria: Meet the criteria for inclusion into WHO Groups II, III, IV or V PAH Are not currently on commercial Ventavis® Have initiated therapy with commercial Ventavis® administered via portable nebulizer less than 3 months prior to study enrollment

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with WHO Group I pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. | Drug: Commercial Ventavis® (iloprost)<br>* Commercial Ventavis® (iloprost) administered via portable nebulizer (I-neb® AAD® system using the power disc-6)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence with instructions for use of Ventavis® |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence of use of Ventavis® |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary arterial hypertension, Ventavis®, iloprost