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 - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00414687

Purpose

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

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: Iloprost aerosol	Phase II

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: Gas High Blood Pressure Pulmonary Hypertension

Drug Information available for: Iloprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Bayer:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	63
Study Start Date:	July 1998
Estimated Study Completion Date:	July 2001

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414687

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Schering Pharma AG, Germany, Medical Affairs

phone: +49 30 46811800

More Information

Study ID Numbers:	300341
Study First Received:	December 20, 2006
Last Updated:	June 8, 2007
ClinicalTrials.gov Identifier:	NCT00414687
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Primary or secondary Pulmonary hypertension
iloprost
inhaled
long-term treatment

Study placed in the following topic categories:

Iloprost
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Vascular Diseases
Neoplasm Metastasis
Secondary pulmonary hypertension
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009