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low recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iloprost | Experimental | single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system |
|
| placebo | Placebo Comparator | matching placebo using the power disc-6 with I-neb AAD system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iloprost | Drug | 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Endurance Time | Change from baseline to week 4 in endurance time during constant work rate exercise testing | Baseline to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Treatment-emergent Adverse Events | Treatment-emergent adverse events up to 24 hours post-end of treatment (EOT), approximately 4 weeks | Baseline up to 24 hours post-EOT, approximately 4 weeks |
| Change in Systolic Pulmonary Arterial Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederic Bodin, MD | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Biomedical Research Institute | Torrance | California | 90502 | United States | ||
| Mayo Clinic Jacksonville |
A total of 22 patients were screened for the study, of these 20 were not randomized because they did not meet the selection criteria.
Patients were screened at 4 centres in the US, one centre in France, and one site in Spain. First patient, first visit was 1 March 2012 and last patient, last visit was 30 November 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iloprost | single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | matching placebo |
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline to week 4 |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70112 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Hopital d'adultes de Brabois | Vandœuvre-lès-Nancy | 54500 | France |
| Hospital Clinic i Provincial | Barcelona | 08036 | Spain |
matching placebo using the power disc-6 with I-neb AAD system
Placebo: matching placebo
| COMPLETED |
|
| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Iloprost | single dose inhalation using the power disc-6 with I-neb AAD system Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks |
| BG001 | Placebo | matching placebo using the power disc-6 with I-neb AAD system Placebo: matching placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Endurance Time | Change from baseline to week 4 in endurance time during constant work rate exercise testing | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | Baseline to week 4 |
|
| ||||||||||||||||||||||
| Secondary | Participants With Treatment-emergent Adverse Events | Treatment-emergent adverse events up to 24 hours post-end of treatment (EOT), approximately 4 weeks | Total population | Posted | Number | participants | Baseline up to 24 hours post-EOT, approximately 4 weeks |
|
| ||||||||||||||||||||
| Secondary | 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. | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | 15 minutes |
|
| ||||||||||||||||||||||
| Secondary | 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. | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | 15 minutes |
|
| ||||||||||||||||||||||
| Secondary | 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. | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | 15 minutes |
|
| ||||||||||||||||||||||
| Secondary | 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. | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | 15 minutes |
|
| ||||||||||||||||||||||
| Secondary | 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. | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | 15 minutes |
|
| ||||||||||||||||||||||
| Secondary | 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. | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | 15 minutes |
|
| ||||||||||||||||||||||
| Secondary | 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. | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | 15 minutes |
|
| ||||||||||||||||||||||
| Secondary | 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. | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | Baseline to week 4 |
|
| ||||||||||||||||||||||
| Secondary | 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. | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | Baseline to week 4 |
|
| ||||||||||||||||||||||
| Secondary | Change in Oxygen Uptake | Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing. | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | Baseline to week 4 |
|
| ||||||||||||||||||||||
| Secondary | Change in Carbon Dioxide Output | Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing. | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | Baseline to week 4 |
|
| ||||||||||||||||||||||
| Secondary | 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. | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | Baseline to week 4 |
|
| ||||||||||||||||||||||
| Secondary | Change in Heart Rate | Change from baseline to week 4. Heart rate was measured during incremental and constant work rate exercise testing. | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | Baseline to week 4 |
|
| ||||||||||||||||||||||
| Secondary | 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. | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | Baseline to week 4 |
|
| ||||||||||||||||||||||
| Secondary | Change in Tidal Volume | Change from baseline to week 4. Tidal volume was measured during incremental and constant work rate exercise testing. | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | Baseline to week 4 |
|
| ||||||||||||||||||||||
| Secondary | Change in Minute Ventilation | Change from baseline to week 4. Minute ventilation was measured during incremental and constant work rate exercise testing. | The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy. | Posted | Baseline to week 4 |
|
|
up to 24 hours post-end of treatment
Treatment-emergent adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iloprost | single dose inhalation using the power disc-6 with I-neb AAD system Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks | 0 | 1 | 0 | 1 | ||
| EG001 | Placebo | matching placebo using the power disc-6 with I-neb AAD system Placebo: matching placebo | 0 | 1 | 0 | 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maziar Assadi Gehr | Actelion Pharmaceutical Ltd | +41 61 565 5525 | maziar.assadi-gehr@actelion.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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| Title | Measurements |
|---|---|
|
| Male |
|
| United States |
|
|