Ventavis® Registry Protocol (RESPIRE)

January 31, 2025 updated by: Actelion

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93721
        • Ucsf Fresno
      • La Jolla, California, United States, 92037
        • UCSD Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Cottage Hospital
    • Colorado
      • Wheatridge, Colorado, United States, 80033
        • Western States Clinical Research
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School Of Medicine
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Orlando, Florida, United States, 32803
        • Central Florida Pulmonary Group
      • Orlando, Florida, United States, 32806
        • Orlando Heart Center
      • Weston, Florida, United States, 33331
        • Cleveland Cliic Florida
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Pulmonary Associates
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine
    • Missouri
      • St. Louis, Missouri, United States, 63104
        • St. Louis University
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Nebraska Pulmonary Specialties
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Nevada Cardiology Associates
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • Buffalo, New York, United States, 14203
        • Kaleida Health/Buffalo General Hospital
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New Hyde Park, New York, United States, 10029
        • North Shore University - LIJ Medical Center
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
      • Syracuse, New York, United States, 13210
        • Pulmonary Health Physicians
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Baylore College of Medicine
    • Utah
      • Provo, Utah, United States, 84057
        • Central Utah Clinic
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
1
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Adherence with instructions for use of Ventavis®
Time Frame: 2 years
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Persistence of use of Ventavis®
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Actelion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC-063A501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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