Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-28 @ 4:20 AM
Study NCT ID:
NCT00902603
Status:
TERMINATED
Last Update Posted:
2025-02-03
First Post:
2009-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventavis® Registry Protocol
Sponsor:
Actelion
Organization:
Study Overview
Official Title:
Registry to Prospectively Evaluate Use of Ventavis® in Patients With Pulmonary Arterial Hypertension
Status:
TERMINATED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low enrollment and difficulty recruiting eligible patients in adequate time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESPIRE
Brief Summary:
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:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: