Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Fibrosis; Pulmonary Hypertension	Drug: Iloprost inhalation	Phase 2; Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	15 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Inhaled Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis
Study Start Date :	March 2007
Study Completion Date :	August 2007

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Safety
2. Pulmonary arterial pressure
3. Exercise capacity (6 minute walking test)

Secondary Outcome Measures :

1. 6 minute walking test: Min. oxygen saturation.
2. NYHA class,
3. Quality of life (St. George Respiratory questionnaires)
4. Pulmonary vascular resistance, cardiac output.
5. Increment of pulmonary arterial pressure after the exercise
6. 6) Pulmonary function test

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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ClinicalTrials.gov Identifier:	NCT00439543 History of Changes
Other Study ID Numbers:	TILOPF
First Posted:	February 23, 2007
Last Update Posted:	February 23, 2007
Last Verified:	February 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