Ventavis® Registry Protocol (RESPIRE)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Registry to Prospectively Evaluate Use of Ventavis® in Patients With Pulmonary Arterial Hypertension|
- Adherence with instructions for use of Ventavis® [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Persistence of use of Ventavis® [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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)
Commercial Ventavis® (iloprost) administered via portable nebulizer (I-neb® AAD® system using the power disc-6)