Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

February 22, 2007 updated by: Interstitial Lung Disease Study Group, Korea

Inhaled Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

15

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Pulmonary Medicine, Asan Medical Center, Ulsan University
        • Principal Investigator:
          • Dong Soon Kim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Pulmonary arterial pressure
Exercise capacity (6 minute walking test)

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Interstitial Lung Disease Study Group, Korea

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion

August 1, 2007

Study Registration Dates

First Submitted

February 22, 2007

First Submitted That Met QC Criteria

February 22, 2007

First Posted (Estimate)

February 23, 2007

Study Record Updates

Last Update Posted (Estimate)

February 23, 2007

Last Update Submitted That Met QC Criteria

February 22, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TILOPF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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