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Ventavis® Registry Protocol

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00902603
Acronym
RESPIRE
Enrollment
148
Registered
2009-05-15
Start date
2009-03-31
Completion date
2014-02-28
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Keywords

pulmonary arterial hypertension, Ventavis®, iloprost

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.

Interventions

DRUGCommercial Ventavis® (iloprost)

Commercial Ventavis® (iloprost) administered via portable nebulizer (I-neb® AAD® system using the power disc-6)

Sponsors

Actelion
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Have a current diagnosis of WHO Group I PAH 2. 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 3. Age \> or = 18 years old at the time of enrollment

Exclusion criteria

1. Meet the criteria for inclusion into WHO Groups II, III, IV or V PAH 2. Are not currently on commercial Ventavis® 3. Have initiated therapy with commercial Ventavis® administered via portable nebulizer less than 3 months prior to study enrollment

Design outcomes

Primary

MeasureTime frame
Adherence with instructions for use of Ventavis®2 years

Secondary

MeasureTime frame
Persistence of use of Ventavis®2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026