Pulmonary FibrosisPhase 2NCT00109681
Inhaled Iloprost in Adults With Abnormal Pulmonary Pressure and Associated With Idiopathic Pulmonary Fibrosis
A Phase 2 study testing Iloprost Inhalation Solution (Ventavis) in people with Pulmonary Fibrosis and Pulmonary Hypertension, run by Actelion at 17 sites in United States.
Trial summary
The primary purpose of this study is to determine whether iloprost inhalation solution is safe in subjects with idiopathic pulmonary fibrosis (IPF) and elevated pulmonary arterial pressure. The secondary purpose is to evaluate the effectiveness of this treatment in subjects with this disease. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Pulmonary Fibrosis, Pulmonary Hypertension
- What is being tested?
- Iloprost Inhalation Solution (Ventavis)
- How many people
- 50 participants
- Where
- 17 sitesUnited States
- Study dates
- Apr 2005to Oct 2006
- Phase
- Phase 2
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic pulmonary fibrosis according to American Thoracic Society criteria
- Diagnosis of elevated pulmonary pressures
- Six minute walk distance between 50-380
- NYHA functional class II - IV
Who cannot join
- Pulmonary fibrosis related to a systemic disorder
- Significant chronic obstructive pulmonary disease
- History of thromboembolic disease within the previous year
- Awaiting lung transplantation within next 36 weeks
- Active lung infection
- Survival prognosis of less than 1 year
Show all 9Show fewer
- Significant left-sided heart failure, active coronary artery disease
- Clinically relevant liver disease
- Concurrent medications: epoprostenol, treprostinil, bosentan, PDE-5 inhibitor, investigational agents
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
University of Alabama at Birmingham
Birmingham, Alabama, 35294
The University of Chicago
Chicago, Illinois, 60637
Inova Research Center
Church Falls, Virginia, 22042
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa College of Medicine
Iowa City, Iowa, 52242
UCLA School of Medicine
Los Angeles, California, 90095
University of Miami
Miami, Florida, 33136
Vanderbilt University Medical
Nashville, Tennessee, 37232
Tulane University
New Orleans, Louisiana, 70112
Mount Sinai Medical Center
New York, New York, 10029
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of California, San Diego
San Diego, California, 92037
University of California, San Francisco
San Francisco, California, 94143
University of Texas Health Center at Tyler
Tyler, Texas, 75708
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety and Pilot Efficacy of Iloprost Inhalation Solution in Adults With Abnormal Pulmonary Arterial Pressure and Exercise Limitation Associated With Idiopathic Pulmonary Fibrosis (IPF)
The primary purpose of this study is to determine whether iloprost inhalation solution is safe in subjects with idiopathic pulmonary fibrosis (IPF) and elevated pulmonary arterial pressure. The secondary purpose is to evaluate the effectiveness of this treatment in subjects with this disease.
Read the detailed description
While there are no FDA approved therapies for the treatment of IPF, there are therapies that have been shown to be effective in ameliorating the effects of pulmonary hypertension in patients with PAH (pulmonary arterial hypertension), including inhaled iloprost. However, these therapies have not been used extensively in patients with IPF who have pulmonary hypertension as a complication. The potential benefits of treatment of pulmonary hypertension complicating IPF include: improvement in pulmonary hemodynamics, with reduction in pulmonary artery pressure and pulmonary vascular resistance, and increase in cardiac output.
- Conditions
- Pulmonary Fibrosis, Pulmonary Hypertension
- Being tested
- Iloprost Inhalation Solution (Ventavis)
- Keywords
- ACTIVE, iloprost, idiopathic pulmonary fibrosis, pulmonary arterial hypertension
- Medical subject headings
- Pulmonary Fibrosis, Hypertension, Pulmonary, Motor Activity, Idiopathic Pulmonary Fibrosis, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iloprost Inhalation Solution (Ventavis)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Secondary outcomes (2)
6 minute walk distance
exercise associated oxygen desaturation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2005 (estimated)
- Study startApr 2005
- Primary completionOct 2006
- Study completionOct 2006
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Pennington, MD, Study director, CoTherix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109681
- Sponsor's protocol ID
- ACTIVE C200-003
- Status last verified
- Feb 2010
- First submitted
- 2 May 2005
- Last updated
- 15 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety and Pilot Efficacy of Iloprost Inhalation Solution in Adults With Abnormal Pulmonary Arterial Pressure and Exercise Limitation Associated With Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT00109681
- Acronym / sponsor ID
- ACTIVE C200-003
- Conditions
- Pulmonary Fibrosis, Pulmonary Hypertension
- Keywords
- ACTIVE, iloprost, idiopathic pulmonary fibrosis, pulmonary arterial hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 3 May 2005 (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.
The primary purpose of this study is to determine whether iloprost inhalation solution is safe in subjects with idiopathic pulmonary fibrosis (IPF) and elevated pulmonary arterial pressure. The secondary purpose is to evaluate the effectiveness of this treatment in subjects with this disease.
Detailed description
While there are no FDA approved therapies for the treatment of IPF, there are therapies that have been shown to be effective in ameliorating the effects of pulmonary hypertension in patients with PAH (pulmonary arterial hypertension), including inhaled iloprost. However, these therapies have not been used extensively in patients with IPF who have pulmonary hypertension as a complication. The potential benefits of treatment of pulmonary hypertension complicating IPF include: improvement in pulmonary hemodynamics, with reduction in pulmonary artery pressure and pulmonary vascular resistance, and increase in cardiac output.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of idiopathic pulmonary fibrosis according to American Thoracic Society criteria
- Diagnosis of elevated pulmonary pressures
- Six minute walk distance between 50-380
- NYHA functional class II - IV
Key exclusion criteria (9 listed)
- Pulmonary fibrosis related to a systemic disorder
- Significant chronic obstructive pulmonary disease
- History of thromboembolic disease within the previous year
- Awaiting lung transplantation within next 36 weeks
- Active lung infection
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 Solution (Ventavis) | Drug | – |
Primary outcome
Safety
2 secondary outcomes
6 minute walk distance
exercise associated oxygen desaturation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2010.
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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.
James Pennington, MD study director
CoTherix
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iloprost Inhalation Solution (Ventavis) in people with Pulmonary Fibrosis and Pulmonary Hypertension, run by Actelion at 17 sites in United States.
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 4 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: finished, as of the sponsor's last update on 15 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety. 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 15 Feb 2010.