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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension

In brief

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.

Key facts

Study ID

NCT01437878

Run by

Actelion

People needed

2

Starts

2012-03-01

Expected to finish

2012-11-01

Last updated by the study team

2015-11-20

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Los Angeles Biomedical Research Institute — Torrance, California, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• 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
• Hospital Clinic i Provincial — Barcelona, Spain

Full record on ClinicalTrials.gov

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