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Ventavis® Registry Protocol (RESPIRE)

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ClinicalTrials.gov Identifier: NCT00902603
Recruitment Status : Terminated (low enrollment and difficulty recruiting eligible patients in adequate time)
First Posted : May 15, 2009
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Actelion

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.

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Drug: Commercial Ventavis® (iloprost)

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 : Observational
Actual Enrollment : 148 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry to Prospectively Evaluate Use of Ventavis® in Patients With Pulmonary Arterial Hypertension
Study Start Date : March 2009
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014


Group/Cohort Intervention/treatment
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)



Primary Outcome Measures :
  1. Adherence with instructions for use of Ventavis® [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Persistence of use of Ventavis® [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902603


  Show 31 Study Locations
Sponsors and Collaborators
Actelion

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00902603     History of Changes
Other Study ID Numbers: AC-063A501
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Actelion:
pulmonary arterial hypertension
Ventavis®
iloprost

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents