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Completed

NCT Number: NCT00414687

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

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

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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Hypertension Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventavis (Iloprost, BAYQ6256)

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
1998
Study completion
2001
First posted
Dec 21, 2006
Registry last updated
May 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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