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

Condition(s) targeted: Pulmonary Hypertension

Intervention: Iloprost aerosol (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Schering Pharma AG, Germany, Medical Affairs, Study Director, Affiliation: phone: +49 30 46811800

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

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Tolerability: Adverse events (AE) and safety variables

Variables to describe clinical effects:

NYHA class

Walking distance (6-min walk)

Mahler Dyspnea Index

EuroQoL

Borg Index

Karnofsky Index

Hemodynamic and gas exchange

Mortality and lung/heart-lung transplantation

Acute effects of iloprost inhalation on hemodynamics and gas exchange

Secondary outcome:

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

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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 contra¬ception

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

Starting date: July 1998
Ending date: July 2001
Last updated: June 8, 2007