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
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ClinicalTrials.gov Identifier: NCT00414687 |
Recruitment Status :
Completed
First Posted : December 21, 2006
Last Update Posted : May 15, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension, Pulmonary | Drug: Ventavis (Iloprost, BAYQ6256) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 63 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | July 1998 |
Actual Study Completion Date : | May 2001 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 |
Drug: Ventavis (Iloprost, BAYQ6256) |
- 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
- 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

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00414687
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Therapeutic Area Head, Bayer Schering Pharma AG |
ClinicalTrials.gov Identifier: | NCT00414687 |
Other Study ID Numbers: |
90427 300341 |
First Posted: | December 21, 2006 Key Record Dates |
Last Update Posted: | May 15, 2009 |
Last Verified: | May 2009 |
Primary or secondary Pulmonary hypertension Iloprost Inhaled Long-term treatment |
Hypertension, Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases Lung Diseases |
Respiratory Tract Diseases Iloprost Platelet Aggregation Inhibitors Vasodilator Agents |