Status:
UNKNOWN
Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis
Lead Sponsor:
Interstitial Lung Disease Study Group, Korea
Conditions:
Pulmonary Fibrosis
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Idiopathic pulmonary fibrosis(IPF) is chronic progressive fibrosing lung disease of unknown cause. There is no effective therapy yet for this disease and the mean survival in most reports is about 3 y...
Detailed Description
* Prospective open labeled observational study * Subjects: About 15 patients with secondary pulmonary hypertension due to IPF or pulmonary fibrosis associated with collagen vascular diseases. * Method...
Eligibility Criteria
Inclusion
- Diagnosis of idiopathic pulmonary fibrosis or fibrotic NSIP according to American Thoracic Society and European Respiratory Society guidelines by biopsy and diagnosis of pulmonary fibrosis associated with connective tissue disease.
- Mean pulmonary artery pressure over 30mmHg.
- NYHA functional class II to IV
Exclusion
- Suffering lung diseases other than pulmonary fibrosis (COPD, Pulmonary Thromboendarterectomy ).
- Administration of prostanoids, bosentan, beta- blocker or phosphodiesterase5 inhibitor.
- Dosage adjustment of calcium channel blockers within 6 weeks.
- Resting pulmonary capillary wedge pressure over 15mmHg.
- Bleeding tendency.
- Bilirubin level above 3mg/dl or creatinine clearance level below 30ml/min.
- Unstable angina pectoris, myocardial infarction or severe arrhythmia within 6 months.
- Cerebrovascular accident within 6 months.
- Present lung infection.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00439543
Start Date
March 1 2007
End Date
August 1 2007
Last Update
February 23 2007
Active Locations (1)
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1
Pulmonary Medicine, Asan Medical Center, Ulsan University
Seoul, South Korea, 138-736