Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Interstitial Lung Disease Study Group, Korea.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Interstitial Lung Disease Study Group, Korea
Information provided by:
Interstitial Lung Disease Study Group, Korea
ClinicalTrials.gov Identifier:
NCT00439543
First received: February 22, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Inhaled Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis |
Resource links provided by NLM:
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 |
- 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439543
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00439543 History of Changes |
| Other Study ID Numbers: | TILOPF |
| Study First Received: | February 22, 2007 |
| Last Updated: | February 22, 2007 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Interstitial Lung Disease Study Group, Korea:
|
Pulmonary fibrosis pulmonary hypertension Iloprost Efficacy |
Additional relevant MeSH terms:
|
Pulmonary Fibrosis Fibrosis Hypertension Hypertension, Pulmonary Cardiovascular Diseases Lung Diseases Pathologic Processes Respiratory Tract Diseases |
Vascular Diseases Iloprost Cardiovascular Agents Hematologic Agents Pharmacologic Actions Platelet Aggregation Inhibitors Therapeutic Uses Vasodilator Agents |
ClinicalTrials.gov processed this record on March 03, 2015