Aerosolized Randomized Iloprost Study II (AIR - II) Long-Term Safety, Tolerability, and Clinical Effects of Iloprost Inhalation in Patients With Primary or Secondary Pulmonary Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the study drug is effective in the long-term treatment of primary or secondary pulmonary hypertension

Detailed Description
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The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
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An Explorative, Open-Label, Multicenter, Randomized, Parallel-Group Comparative Study of Safety, Tolerability, and the Clinical Effects of Iloprost Inhalation in Patients With Primary or Secondary Pulmonary Hypertension Over 2 Years

Conditions
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Hypertension, Pulmonary

Intervention / Treatment
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* Drug: Ventavis (Iloprost, BAYQ6256)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients Secondary pulmonary hypertension Mean pulmonary artery pressure equal or above 40 mmHg or primary pulmonary hypertension with a pressure equal or above 30 mmHg while resting during appropriate conventional treatment Written informed consent after having been duly informed about all diagnostic and therapeutic measures involved in the study Exclusion Criteria: Clinical Instability at baseline Pulmonary venous obstruction Global respiratory insufficiency Obstructive ventilation disorders, Interstitial pulmonary disease Cerebrovascular events Myocardial infarction or major cardiac surgery within 3 months prior to baseline Bleeding disorders or bleeding risk Severe hepatic insufficiency or renal insufficiency Malignant diseases HIV positive Pregnancy, female patients of child-bearing potential without adequate contraception and nursing mothers Congenital or acquired valvular defects and myocardial function disorders not related to pulmonary hypertension Prior pulmonary embolism Collagenosis Pulmonary arterial or valvular stenosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Ventavis (Iloprost, BAYQ6256)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability: Adverse events (AE) and safety variables, Variables to describe clinical effects: NYHA class, Walking distance (6-min walk), Mahler Dyspnea Index, EuroQoL, Karnofsky Index, Hemodynamic and gas exchange |  |  | 
| Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall clinical tolerability of the long-term use of iloprost aerosol |  |  | 
| Serious Adverse Events and deaths |  |  | 
| Effect of long-term administration of inhaled iloprost on mortality and transplantation |  |  | 
| Exercise capacity |  |  | 
| Acute effect of inhaled iloprost on hemodynamics and gas exchange |  |  | 
| Effects of long-term administration of inhaled iloprost on hemodynamics and gas exchange |  |  | 
| Quality of Life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary or secondary Pulmonary hypertension, Iloprost, Inhaled, Long-term treatment