Clinical trial 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
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension, Pulmonary
Keywords: Primary or secondary Pulmonary hypertension
Iloprost
Inhaled
Long-term treatment
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-12-21
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
measure: Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange
Secondary outcomes:
measure: Overall clinical tolerability of the long-term use of iloprost aerosol
measure: Serious Adverse Events and deaths
measure: Effect of long-term administration of inhaled iloprost on mortality and transplantation
measure: Exercise capacity
measure: Acute effect of inhaled iloprost on hemodynamics and gas exchange
measure: Effects of long-term administration of inhaled iloprost on hemodynamics and gas exchange
measure: Quality of Life
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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.