Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

Pulmonary Hypertension Clinical Trial

Official title:

Inhaled Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00439543
• Other study ID #: TILOPF
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: February 22, 2007
• Last updated: February 22, 2007
• Start date: March 2007
• Est. completion date: August 2007

Study information

• Verified date: February 2007
• Source: Interstitial Lung Disease Study Group, Korea
• Contact: Dong Soon Kim, MD
• Phone: 822-3010-3132
• Email: dskim[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Fibrosis
• Pulmonary Hypertension

Intervention

Drug:
• Iloprost inhalation

Locations

Country	Name	City	State
Korea, Republic of	Pulmonary Medicine, Asan Medical Center, Ulsan University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Interstitial Lung Disease Study Group, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Primary	Pulmonary arterial pressure
Primary	Exercise capacity (6 minute walking test)
Secondary	6 minute walking test: Min. oxygen saturation.
Secondary	NYHA class,
Secondary	Quality of life (St. George Respiratory questionnaires)
Secondary	Pulmonary vascular resistance, cardiac output.
Secondary	Increment of pulmonary arterial pressure after the exercise
Secondary	6) Pulmonary function test