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Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Interstitial Lung Disease Study Group, Korea.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Interstitial Lung Disease Study Group, Korea
ClinicalTrials.gov Identifier:
NCT00439543
First received: February 22, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose
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 Intervention Phase
Pulmonary Fibrosis
Pulmonary Hypertension
 Drug: Iloprost inhalation
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Inhaled Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

Resource links provided by NLM:

Drug Information available for: Iloprost
U.S. FDA Resources

Further study details as provided by Interstitial Lung Disease Study Group, Korea:

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
Estimated Enrollment: 15
Study Start Date: March 2007
Estimated Study Completion Date: August 2007
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.
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439543

Contacts
Contact: Dong Soon Kim, MD 822-3010-3132 dskim@amc.seoul.kr
Contact: Sook Hee Jung, RN 8211-9858-9228 79suk-hee@hanmail.net

Locations
Korea, Republic of
Pulmonary Medicine, Asan Medical Center, Ulsan University Not yet recruiting
Seoul, Korea, Republic of, 138-736
Principal Investigator: Dong Soon Kim, MD         
Sponsors and Collaborators
Interstitial Lung Disease Study Group, Korea
Investigators
Principal Investigator: Dong Soon Kim, MD Asan Medical Center, Ulsan University, Seoul, Korea, Republic of
  More Information

ClinicalTrials.gov Identifier: NCT00439543     History of Changes
Other Study ID Numbers: TILOPF 
Study First Received: February 22, 2007
Last Updated: February 22, 2007
Health Authority: Korea: Food and Drug Administration

Keywords provided by Interstitial Lung Disease Study Group, Korea:
Pulmonary fibrosis
pulmonary hypertension
Iloprost
Efficacy

Additional relevant MeSH terms:
Pulmonary Fibrosis
Hypertension
Fibrosis
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents

ClinicalTrials.gov processed this record on September 29, 2016