Ventavis® Registry Protocol

Pulmonary Arterial Hypertension Clinical Trial

— RESPIRE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00902603
• Other study ID #: AC-063A501
• Status: Terminated
• Phase: N/A
• First received: May 13, 2009
• Last updated: April 9, 2015
• Start date: March 2009
• Est. completion date: February 2014

Study information

• Verified date: April 2015
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 148
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Montefiore Medical Center	Bronx	New York
United States	Kaleida Health/Buffalo General Hospital	Buffalo	New York
United States	University of Cincinnati	Cincinnati	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	UCSF Fresno	Fresno	California
United States	University of Florida	Gainesville	Florida
United States	Baylore College of Medicine	Houston	Texas
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	UCSD Medical Center	La Jolla	California
United States	Nebraska Pulmonary Specialties	Lincoln	Nebraska
United States	UCLA	Los Angeles	California
United States	Kentuckiana Pulmonary Associates	Louisville	Kentucky
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	Yale University School of Medicine	New Haven	Connecticut
United States	North Shore University - LIJ Medical Center	New Hyde Park	New York
United States	Ochsner Clinic	New Orleans	Louisiana
United States	Beth Israel Medical Center	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Central Florida Pulmonary Group	Orlando	Florida
United States	Orlando Heart Center	Orlando	Florida
United States	Central Utah Clinic	Provo	Utah
United States	Sierra Nevada Cardiology Associates	Reno	Nevada
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	St. Louis University	St. Louis	Missouri
United States	Pulmonary Health Physicians	Syracuse	New York
United States	Cleveland Cliic Florida	Weston	Florida
United States	Western States Clinical Research	Wheatridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence with instructions for use of Ventavis®		2 years	No
Secondary	Persistence of use of Ventavis®		2 years	No