Pulmonary FibrosisPhase 2/3NCT00439543
Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis
A Phase 2/3 study testing Iloprost inhalation in people with Pulmonary Fibrosis and Pulmonary Hypertension, run by Interstitial Lung Disease Study Group, Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis, Pulmonary Hypertension
- What is being tested?
- Iloprost inhalation
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2007to Aug 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Unstable angina pectoris, myocardial infarction or severe arrhythmia within 6 months.
- Cerebrovascular accident within 6 months.
- Present lung infection.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pulmonary Medicine, Asan Medical Center, Ulsan University
Seoul, 138-736
Dong Soon Kim, MD
About this study
Official title: Inhaled Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis
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.
Read the 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.
- Conditions
- Pulmonary Fibrosis, Pulmonary Hypertension
- Being tested
- Iloprost inhalation
- Keywords
- Pulmonary fibrosis, pulmonary hypertension, Iloprost, Efficacy
- Medical subject headings
- Pulmonary Fibrosis, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iloprost inhalationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
6) Pulmonary function test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startMar 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Interstitial Lung Disease Study Group, Korea
- Sponsor type
- Research network
- Investigators
- Dong Soon Kim, MD, Principal investigator, Asan Medical Center, Ulsan University, Seoul, Korea, Republic of
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439543
- Sponsor's protocol ID
- TILOPF
- Status last verified
- Feb 2007
- First submitted
- 22 Feb 2007
- Last updated
- 23 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT00439543
- Acronym / sponsor ID
- TILOPF
- Conditions
- Pulmonary Fibrosis, Pulmonary Hypertension
- Keywords
- Pulmonary fibrosis, pulmonary hypertension, Iloprost, Efficacy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants
- Lead sponsor
- Interstitial Lung Disease Study Group, KoreaResearch network
- Study start
- Mar 2007
- Study completion
- Aug 2007
- First posted
- 23 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iloprost inhalation | Drug | – |
Primary outcome
Safety
Pulmonary arterial pressure
Exercise capacity (6 minute walking test)
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Soon Kim, MD principal investigator
Asan Medical Center, Ulsan University, Seoul, Korea, Republic of
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Iloprost inhalation in people with Pulmonary Fibrosis and Pulmonary Hypertension, run by Interstitial Lung Disease Study Group, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Soon Kim, MD (822-3010-3132, dskim@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2007.