Trial Condition(s):
Hypertension, Pulmonary
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
Bayer Identifier:
90427
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status |
|---|
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
1
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 exchangeTimeframe:
- Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchangeTimeframe:
Secondary Outcome
- Overall clinical tolerability of the long-term use of iloprost aerosolTimeframe:
- Serious Adverse Events and deathsTimeframe:
- Effect of long-term administration of inhaled iloprost on mortality and transplantationTimeframe:
- Exercise capacityTimeframe:
- Acute effect of inhaled iloprost on hemodynamics and gas exchangeTimeframe:
- Effects of long-term administration of inhaled iloprost on hemodynamics and gas exchangeTimeframe:
- Quality of LifeTimeframe:
Additional Information
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