Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

Sponsor

Interstitial Lung Disease Study Group, Korea (Other)

Overall Status

Unknown status

CT.gov ID

NCT00439543

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 years after the diagnosis. Because of the stiff fibrosis of the lung, pulmonary hypertension is the late complication of IPF and its development heralds a very poor outcome of the patients. For the primary pulmonary hypertension, recently the effective drugs have been available. However, there is no study about the efficacy of these drugs in the patients with pulmonary hypertension secondary to pulmnary fibrosis, and the aim of this trial is to study the safty and efficacy of "Iloprost," one of the safe and effective drugs in primary pulmonary hypertension.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Fibrosis Pulmonary Hypertension	Drug: Iloprost inhalation	Phase 2/Phase 3

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: 3 month trial of inhaled iloprost. Check the safty and measure the pulmonary arterial pressure by right heart catheterization, exercise capacity by 6 minute walking test, echocardiography, and quality of life questionnaires before and after the trial.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Inhaled Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

Study Start Date :

Mar 1, 2007

Study Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

Safety []
Pulmonary arterial pressure []
Exercise capacity (6 minute walking test) []

Secondary Outcome Measures

6 minute walking test: Min. oxygen saturation. []
NYHA class, []
Quality of life (St. George Respiratory questionnaires) []
Pulmonary vascular resistance, cardiac output. []
Increment of pulmonary arterial pressure after the exercise []
6) Pulmonary function test []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.