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Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

Primary Purpose

Pulmonary Fibrosis, Pulmonary Hypertension

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Iloprost inhalation
Sponsored by
Interstitial Lung Disease Study Group, Korea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Fibrosis focused on measuring Pulmonary fibrosis, pulmonary hypertension, Iloprost, Efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pulmonary Medicine, Asan Medical Center, Ulsan University

Outcomes

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

Full Information

First Posted
February 22, 2007
Last Updated
February 22, 2007
Sponsor
Interstitial Lung Disease Study Group, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00439543
Brief Title
Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis
Official Title
Inhaled Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Interstitial Lung Disease Study Group, Korea

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Fibrosis, Pulmonary Hypertension
Keywords
Pulmonary fibrosis, pulmonary hypertension, Iloprost, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Iloprost inhalation
Primary Outcome Measure Information:
Title
Safety
Title
Pulmonary arterial pressure
Title
Exercise capacity (6 minute walking test)
Secondary Outcome Measure Information:
Title
6 minute walking test: Min. oxygen saturation.
Title
NYHA class,
Title
Quality of life (St. George Respiratory questionnaires)
Title
Pulmonary vascular resistance, cardiac output.
Title
Increment of pulmonary arterial pressure after the exercise
Title
6) Pulmonary function test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Soon Kim, MD
Phone
822-3010-3132
Email
dskim@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Sook Hee Jung, RN
Phone
8211-9858-9228
Email
79suk-hee@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Soon Kim, MD
Organizational Affiliation
Asan Medical Center, Ulsan University, Seoul, Korea, Republic of
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary Medicine, Asan Medical Center, Ulsan University
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Soon Kim, MD

12. IPD Sharing Statement

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Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

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