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 Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Hypertension, Pulmonary	Drug: Ventavis (Iloprost, BAYQ6256)	Phase 2

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.

Study Design

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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

Arms and Interventions

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

Outcome Measures

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Primary Outcome Measures :

1. 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
2. Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange

Secondary Outcome Measures :

1. Overall clinical tolerability of the long-term use of iloprost aerosol
2. Serious Adverse Events and deaths
3. Effect of long-term administration of inhaled iloprost on mortality and transplantation
4. Exercise capacity
5. Acute effect of inhaled iloprost on hemodynamics and gas exchange
6. Effects of long-term administration of inhaled iloprost on hemodynamics and gas exchange
7. Quality of Life

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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 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

Contacts and Locations

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Sponsors and Collaborators

Bayer

Investigators

Study Director:	Bayer Study Director	Bayer

More Information

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Additional Information:

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Olschewski H, Hoeper MM, Behr J, Ewert R, Meyer A, Borst MM, Winkler J, Pfeifer M, Wilkens H, Ghofrani HA, Nikkho S, Seeger W. Long-term therapy with inhaled iloprost in patients with pulmonary hypertension. Respir Med. 2010 May;104(5):731-40. doi: 10.1016/j.rmed.2010.01.008. Epub 2010 Feb 11.

Responsible Party:	Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier:	NCT00414687 History of Changes
Other Study ID Numbers:	90427; 300341
First Posted:	December 21, 2006
Last Update Posted:	May 15, 2009
Last Verified:	May 2009

Keywords provided by Bayer:

Primary or secondary Pulmonary hypertension; Iloprost; Inhaled; Long-term treatment

Additional relevant MeSH terms:

Hypertension; Hypertension, Pulmonary; Vascular Diseases; Cardiovascular Diseases; Lung Diseases	Respiratory Tract Diseases; Iloprost; Platelet Aggregation Inhibitors; Vasodilator Agents