Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00439543 |
Recruitment Status
: Unknown
Verified February 2007 by Interstitial Lung Disease Study Group, Korea.
Recruitment status was: Not yet recruiting
First Posted
: February 23, 2007
Last Update Posted
: February 23, 2007
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Fibrosis Pulmonary Hypertension | Drug: Iloprost inhalation | Phase 2 Phase 3 |
- 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 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 |

- Safety
- Pulmonary arterial pressure
- Exercise capacity (6 minute walking test)
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439543
Contact: Dong Soon Kim, MD | 822-3010-3132 | dskim@amc.seoul.kr | |
Contact: Sook Hee Jung, RN | 8211-9858-9228 | 79suk-hee@hanmail.net |
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 |
Principal Investigator: | Dong Soon Kim, MD | Asan Medical Center, Ulsan University, Seoul, Korea, Republic of |
ClinicalTrials.gov Identifier: | NCT00439543 History of Changes |
Other Study ID Numbers: |
TILOPF |
First Posted: | February 23, 2007 Key Record Dates |
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 |