Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

Brief Title

Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

Official Title

Inhaled Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

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.
    

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 Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Safety

Secondary Outcome

 6 minute walking test: Min. oxygen saturation.

Condition

Pulmonary Fibrosis

Intervention

Iloprost inhalation


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

15

Start Date

March 2007

Completion Date

August 2007


Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Dong Soon Kim, MD, 822-3010-3132, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT00439543

Organization ID

TILOPF



Study Sponsor

Interstitial Lung Disease Study Group, Korea


Study Sponsor

Dong Soon Kim, MD, Principal Investigator, Asan Medical Center, Ulsan University, Seoul, Korea, Republic of


Verification Date

February 2007