Chronic Obstructive Pulmonary DiseasePhase 2NCT01437878
Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Iloprost in people with Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension, run by Actelion at 11 sites in 3 countries.
Trial summary
This is a phase 2, Multi-center, double-blind, randomized, placebo-controlled study to evaluate the effects of inhaled Iloprost in patients with pulmonary hypertension secondary to COPD. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension
- What is being tested?
- Iloprost
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Mar 2012to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to initiation of any study mandated procedure
- Male or female ≥ 40 and ≤ 75 years of age
- Women of childbearing potential1 must use a reliable method of contraception
- Clinical diagnosis of moderate to severe COPD, with an obstructive pattern on pulmonary function tests
- Current or past smokers of ≥ 10 pack years
- Ability to perform exercise testing without supplemental oxygen (in the best opinion of the investigator)
- Confirmed pulmonary hypertension by right heart catheterization (RHC)
Who cannot join
- Other causes of pulmonary hypertension than COPD
- BMI > 35 kg/m2
- Conditions considered as contraindications for cardiopulmonary exercise testing (CPET) and/or inability to pedal on a cycle ergometer
- Pregnant or nursing
- Currently (within 30 days prior to RHC) taking specific pulmonary arterial hypertension (PAH) therapy (e.g., bosentan, ambrisentan, tadalafil, sildenafil, epoprostenol, treprostinil, iloprost, beraprost)
- Participation in any other clinical trial, except observational, or receipt of an investigational product within 30 days prior to RHC visit
- Known concomitant life-threatening disease with a life expectancy < 12 months
- Known hypersensitivity to iloprost or any of the excipients of the drug formulations
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States9 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Ochsner Clinic Foundation
New Orleans, Louisiana, 70112
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Temple University Hospital
Philadelphia, Pennsylvania, 19140
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Los Angeles Biomedical Research Institute
Torrance, California, 90502
About this study
Official title: A Phase 2, Multi-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Inhaled Iloprost on Endurance Time During Cardiopulmonary Exercise Testing in Patients With Pulmonary Hypertension Secondary to Chronic Obstructive Pulmonary Disease
This is a phase 2, Multi-center, double-blind, randomized, placebo-controlled study to evaluate the effects of inhaled Iloprost in patients with pulmonary hypertension secondary to COPD. The main objective is to investigate the effect of iloprost on exercise endurance time during constant work rate cardiopulmonary exercise testing. Other efficacy and safety endpoints will additionally be analyzed.
- Being tested
- Iloprost, Placebo
- Keywords
- PH, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IloprostDrug
Also called Ventavis
5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| iloprost | Experimental | single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system Receives: Drug: Iloprost |
| placebo | Placebo comparator | matching placebo using the power disc-6 with I-neb AAD system Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endurance Time
Change from baseline to week 4 in endurance time during constant work rate exercise testing
Measured: Baseline to week 4
Secondary outcomes (17)
Participants With Treatment-emergent Adverse Events
Treatment-emergent adverse events up to 24 hours post-end of treatment (EOT), approximately 4 weeks
Measured: Baseline up to 24 hours post-EOT, approximately 4 weeks
Change in Systolic Pulmonary Arterial Pressure
On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.
Measured: 15 minutes
Change in Diastolic Pulmonary Arterial Pressure
On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.
Measured: 15 minutes
Change in Mean Pulmonary Arterial Pressure
On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.
Measured: 15 minutes
Change in Mean Right Atrial Pressure
On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.
Measured: 15 minutes
Change in Cardiac Output
On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.
Measured: 15 minutes
Change in Right Ventricular Pressure
On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.
Measured: 15 minutes
Change in Pulmonary Vascular Resistance
On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.
Measured: 15 minutes
Change in End Tidal Partial Pressure of Carbon Dioxide
Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Measured: Baseline to week 4
Change in End Tidal Partial Pressure of Oxygen
Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Measured: Baseline to week 4
Change in Oxygen Uptake
Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Measured: Baseline to week 4
Change in Carbon Dioxide Output
Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Measured: Baseline to week 4
Change in Oxygen Uptake Per Heartbeat
Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Measured: Baseline to week 4
Change in Heart Rate
Change from baseline to week 4. Heart rate was measured during incremental and constant work rate exercise testing.
Measured: Baseline to week 4
Change in Arterial Oxygen Saturation as Indicated by Pulse Oximetry
Change from baseline to week 4. Arterial oxygen was determined by pulse oximetry during incremental and constant work rate exercise testing.
Measured: Baseline to week 4
Change in Tidal Volume
Change from baseline to week 4. Tidal volume was measured during incremental and constant work rate exercise testing.
Measured: Baseline to week 4
Change in Minute Ventilation
Change from baseline to week 4. Minute ventilation was measured during incremental and constant work rate exercise testing.
Measured: Baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startMar 2012
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederic Bodin, MD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437878
- Sponsor's protocol ID
- AC-063B201
- Status last verified
- Oct 2015
- First submitted
- 20 Sep 2011
- Last updated
- 20 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Inhaled Iloprost on Endurance Time During Cardiopulmonary Exercise Testing in Patients With Pulmonary Hypertension Secondary to Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01437878
- Acronym / sponsor ID
- AC-063B201
- Keywords
- PH, COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 21 Sep 2011 (estimated)
- Results
- Posted 6 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2, Multi-center, double-blind, randomized, placebo-controlled study to evaluate the effects of inhaled Iloprost in patients with pulmonary hypertension secondary to COPD. The main objective is to investigate the effect of iloprost on exercise endurance time during constant work rate cardiopulmonary exercise testing. Other efficacy and safety endpoints will additionally be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iloprost | Experimental | Drug: Iloprostsingle dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system |
| placebo | Placebo comparator | Drug: Placebomatching placebo using the power disc-6 with I-neb AAD system |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent prior to initiation of any study mandated procedure
- Male or female ≥ 40 and ≤ 75 years of age
- Women of childbearing potential1 must use a reliable method of contraception
- Clinical diagnosis of moderate to severe COPD, with an obstructive pattern on pulmonary function tests
- Current or past smokers of ≥ 10 pack years
Key exclusion criteria (8 listed)
- Other causes of pulmonary hypertension than COPD
- BMI > 35 kg/m2
- Conditions considered as contraindications for cardiopulmonary exercise testing (CPET) and/or inability to pedal on a cycle ergometer
- Pregnant or nursing
- Currently (within 30 days prior to RHC) taking specific pulmonary arterial hypertension (PAH) therapy (e.g., bosentan, ambrisentan, tadalafil, sildenafil, epoprostenol, treprostinil, iloprost, beraprost)
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 |
|---|---|---|
| IloprostAlso: Ventavis5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks | Drug | iloprost |
| Placebomatching placebo | Drug | placebo |
Primary outcome
Change in Endurance Time
Time frame: Baseline to week 4
Change from baseline to week 4 in endurance time during constant work rate exercise testing
17 secondary outcomes
Participants With Treatment-emergent Adverse Events
Time frame: Baseline up to 24 hours post-EOT, approximately 4 weeks
Change in Systolic Pulmonary Arterial Pressure
Time frame: 15 minutes
Change in Diastolic Pulmonary Arterial Pressure
Time frame: 15 minutes
Change in Mean Pulmonary Arterial Pressure
Time frame: 15 minutes
Change in Mean Right Atrial Pressure
Time frame: 15 minutes
Change in Cardiac Output
Time frame: 15 minutes
Change in Right Ventricular Pressure
Time frame: 15 minutes
Change in Pulmonary Vascular Resistance
Time frame: 15 minutes
Change in End Tidal Partial Pressure of Carbon Dioxide
Time frame: Baseline to week 4
Change in End Tidal Partial Pressure of Oxygen
Time frame: Baseline to week 4
Change in Oxygen Uptake
Time frame: Baseline to week 4
Change in Carbon Dioxide Output
Time frame: Baseline to week 4
Change in Oxygen Uptake Per Heartbeat
Time frame: Baseline to week 4
Change in Heart Rate
Time frame: Baseline to week 4
Change in Arterial Oxygen Saturation as Indicated by Pulse Oximetry
Time frame: Baseline to week 4
Change in Tidal Volume
Time frame: Baseline to week 4
Change in Minute Ventilation
Time frame: Baseline to week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Frederic Bodin, MD study director
Actelion
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iloprost in people with Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension, run by Actelion at 11 sites in 3 countries.
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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, France, Spain. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 6 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Endurance Time (time frame: Baseline to week 4). 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 20 Nov 2015.