Clinical Trial: 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 Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:

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.


Sponsor: Bayer

Current 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, Karnofsky Index, Hemodynamic and gas exchange
  • Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange


Original 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


Current 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


Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: December 20, 2006
Date Started: July 1998
Date Completion:
Last Updated: May 14, 2009
Last Verified: May 2009