Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis - Full Text View

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 II Phase III

Genetics Home Reference related topics:

pulmonary arterial hypertension

MedlinePlus related topics:

Exercise and Physical Fitness High Blood Pressure Pulmonary Fibrosis Pulmonary Hypertension

ChemIDplus related topics:

Iloprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Inhaled Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

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
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

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

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

Keywords provided by Interstitial Lung Disease Study Group, Korea:

Pulmonary fibrosis

pulmonary hypertension

Iloprost

Efficacy

Study placed in the following topic categories:

Iloprost

Lung Diseases, Interstitial

Respiratory Tract Diseases

Fibrosis

Hypertension, Pulmonary

Lung Diseases

Vascular Diseases

Neoplasm Metastasis

Secondary pulmonary hypertension

Pulmonary Fibrosis

Hypertension

Additional relevant MeSH terms:

Vasodilator Agents

Pathologic Processes

Therapeutic Uses

Hematologic Agents

Platelet Aggregation Inhibitors

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Interstitial Lung Disease Study Group, Korea
Information provided by:	Interstitial Lung Disease Study Group, Korea
ClinicalTrials.gov Identifier:	NCT00439543