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

Phase 2TerminatedNCT01437878

Actelion2 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease Pulmonary Hypertension

Interventions

IloprostDRUG

5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks

PlaceboDRUG

matching placebo

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (11)

Los Angeles Biomedical Research Institute

Torrance, California, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Northwestern University

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Change in Endurance Time

Change from baseline to week 4 in endurance time during constant work rate exercise testing

Time frame: Baseline to week 4

Secondary Outcomes

Participants With Treatment-emergent Adverse Events

Treatment-emergent adverse events up to 24 hours post-end of treatment (EOT), approximately 4 weeks

Time frame: 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.

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

Data from ClinicalTrials.gov

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Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Hopital d'adultes de Brabois

Vandœuvre-lès-Nancy, France

...and 1 more locations

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

Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to week 4