Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD)

Phase 2

Terminated

• Conditions: Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Placebo; Drug: Iloprost

• Registration Number: NCT01437878
• Lead Sponsor: Actelion

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-20
• Study First Posted: 2011-09-21
• Study Start: 2012-03
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2014-12-12
• Results First Submitted QC: 2015-01-02
• Results First Posted: 2015-01-06
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-16
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1. Signed informed consent prior to initiation of any study mandated procedure
2. Male or female ≥ 40 and ≤ 75 years of age
3. Women of childbearing potential1 must use a reliable method of contraception
4. Clinical diagnosis of moderate to severe COPD, with an obstructive pattern on pulmonary function tests
5. Current or past smokers of ≥ 10 pack years
6. Ability to perform exercise testing without supplemental oxygen (in the best opinion of the investigator)
7. Confirmed pulmonary hypertension by right heart catheterization (RHC)

Exclusion Criteria

1. Other causes of pulmonary hypertension than COPD
2. BMI > 35 kg/m2
3. Conditions considered as contraindications for cardiopulmonary exercise testing (CPET) and/or inability to pedal on a cycle ergometer
4. Pregnant or nursing
5. Currently (within 30 days prior to RHC) taking specific pulmonary arterial hypertension (PAH) therapy (e.g., bosentan, ambrisentan, tadalafil, sildenafil, epoprostenol, treprostinil, iloprost, beraprost)
6. Participation in any other clinical trial, except observational, or receipt of an investigational product within 30 days prior to RHC visit
7. Known concomitant life-threatening disease with a life expectancy < 12 months
8. Known hypersensitivity to iloprost or any of the excipients of the drug formulations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	matching placebo using the power disc-6 with I-neb AAD system
iloprost	Iloprost	single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system

Primary Outcome Measures

Name	Time	Method
Change in Endurance Time	Baseline to week 4	Change from baseline to week 4 in endurance time during constant work rate exercise testing

Secondary Outcome Measures

Name	Time	Method
Change in Cardiac Output	15 minutes	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.
Change in End Tidal Partial Pressure of Oxygen	Baseline to week 4	Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Change in Systolic Pulmonary Arterial Pressure	15 minutes	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.
Change in Mean Right Atrial Pressure	15 minutes	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.
Change in Right Ventricular Pressure	15 minutes	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.
Change in Pulmonary Vascular Resistance	15 minutes	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.
Change in Diastolic Pulmonary Arterial Pressure	15 minutes	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.
Change in End Tidal Partial Pressure of Carbon Dioxide	Baseline to week 4	Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Change in Oxygen Uptake	Baseline to week 4	Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Change in Carbon Dioxide Output	Baseline to week 4	Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Change in Arterial Oxygen Saturation as Indicated by Pulse Oximetry	Baseline to week 4	Change from baseline to week 4. Arterial oxygen was determined by pulse oximetry during incremental and constant work rate exercise testing.
Change in Tidal Volume	Baseline to week 4	Change from baseline to week 4. Tidal volume was measured during incremental and constant work rate exercise testing.
Participants With Treatment-emergent Adverse Events	Baseline up to 24 hours post-EOT, approximately 4 weeks	Treatment-emergent adverse events up to 24 hours post-end of treatment (EOT), approximately 4 weeks
Change in Mean Pulmonary Arterial Pressure	15 minutes	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.
Change in Heart Rate	Baseline to week 4	Change from baseline to week 4. Heart rate was measured during incremental and constant work rate exercise testing.
Change in Oxygen Uptake Per Heartbeat	Baseline to week 4	Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Change in Minute Ventilation	Baseline to week 4	Change from baseline to week 4. Minute ventilation was measured during incremental and constant work rate exercise testing.

Trial Locations

Locations (11)

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Hospital Clinic i Provincial; 🇪🇸 Barcelona, Spain

Los Angeles Biomedical Research Institute; 🇺🇸 Torrance, California, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

Hopital d'adultes de Brabois; 🇫🇷 Vandoeuvre-lès-Nancy, France