Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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 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:

MedlinePlus related topics: Pulmonary Fibrosis Pulmonary Hypertension

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)
Sexes Eligible for Study:	All
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

Keywords provided by Interstitial Lung Disease Study Group, Korea:


Pulmonary fibrosis pulmonary hypertension Iloprost Efficacy

Additional relevant MeSH terms:


Hypertension Fibrosis Hypertension, Pulmonary Pulmonary Fibrosis Vascular Diseases Cardiovascular Diseases	Pathologic Processes Lung Diseases Respiratory Tract Diseases Iloprost Platelet Aggregation Inhibitors Vasodilator Agents

ClinicalTrials.gov processed this record on June 23, 2017

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