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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

Primary Purpose

Hypertension, Pulmonary

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ventavis (Iloprost, BAYQ6256)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring Primary or secondary Pulmonary hypertension, Iloprost, Inhaled, Long-term treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Arm 1

    Arm Description

    Outcomes

    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, 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

    Full Information

    First Posted
    December 20, 2006
    Last Updated
    May 14, 2009
    Sponsor
    Bayer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00414687
    Brief Title
    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
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1998 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2001 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Bayer

    4. Oversight

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Pulmonary
    Keywords
    Primary or secondary Pulmonary hypertension, Iloprost, Inhaled, Long-term treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Ventavis (Iloprost, BAYQ6256)
    Primary Outcome Measure Information:
    Title
    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
    Title
    Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange
    Secondary Outcome Measure Information:
    Title
    Overall clinical tolerability of the long-term use of iloprost aerosol
    Title
    Serious Adverse Events and deaths
    Title
    Effect of long-term administration of inhaled iloprost on mortality and transplantation
    Title
    Exercise capacity
    Title
    Acute effect of inhaled iloprost on hemodynamics and gas exchange
    Title
    Effects of long-term administration of inhaled iloprost on hemodynamics and gas exchange
    Title
    Quality of Life

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bayer Study Director
    Organizational Affiliation
    Bayer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20153158
    Citation
    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.
    Results Reference
    derived

    Learn more about this 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

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