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TERMINATEDPHASE2

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

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

NCT01437878•Actelion

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 75 years

Sex

ALL

Healthy Volunteers

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

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

Key Dates

Start Date

March 1, 2012

Primary Completion Date

November 1, 2012

Completion Date

November 1, 2012

Last Updated

November 20, 2015

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary DiseasePulmonary Hypertension

Interventions

Iloprost

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

cfMSC Stem Cell Therapy Targeting COPD

Preliminary Human Trials of F230 Tablets

Sildinafil in Pulmonary Hypertension-Rheumatic Chronic Valvular Disease(RCT)

Prospective Evaluation of AI-ECG for SHD Detection

Pulmonary Hypertension in Left Heart Disease