Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

NCT00439543 | Unknown Phase 2

• 1 other identifier: TILOPF
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Fibrosis; Pulmonary Hypertension

Keywords

Pulmonary fibrosis; pulmonary hypertension; Iloprost; Efficacy

Outcome Measures

Primary Outcomes (3)

• Safety

• Pulmonary arterial pressure

• Exercise capacity (6 minute walking test)

Secondary Outcomes (6)

• 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

Interventions

Iloprost inhalation DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Interstitial Lung Disease Study Group, Korea: lead

Study Sites (1)

Pulmonary Medicine, Asan Medical Center, Ulsan University

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Pulmonary Fibrosis; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dong Soon Kim, MD

  Asan Medical Center, Ulsan University, Seoul, Korea, Republic of

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Soon Kim, MD

CONTACT

822-3010-3132; dskim@amc.seoul.kr

Sook Hee Jung, RN

CONTACT

8211-9858-9228; 79suk-hee@hanmail.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 23, 2007
• Study Start: March 1, 2007
• Study Completion: August 1, 2007
• Last Updated: February 23, 2007

Record last verified: 2007-02

Locations

KR (1)