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

Purpose

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 additional analyzed.

Condition	Intervention	Phase
Pulmonary Hypertension Chronic Obstructive Pulmonary Disease	Drug: Iloprost Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Exercise and Physical Fitness High Blood Pressure Pulmonary Hypertension

Drug Information available for: Iloprost

U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:

change in endurance time [ Time Frame: baseline to week 4 ] [ Designated as safety issue: No ]
change from baseline to week 4 in endurance time during constant work rate exercise testing

Secondary Outcome Measures:

treatment-emergent adverse events [ Time Frame: 24 hours post EOT ] [ Designated as safety issue: Yes ]
treatment-emergent adverse events up to 24 hours post-EOT

Enrollment:	2
Study Start Date:	March 2012
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: iloprost single dose inhalation using the power disc-6 with I-neb AAD system	Drug: Iloprost 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks Other Name: Ventavis
Placebo Comparator: placebo matching placebo using the power disc-6 with I-neb AAD system	Drug: Placebo matching placebo Other Name: Placebo

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

Other causes of pulmonary hypertension than COPD
BMI > 35 kg/m2
Conditions considered as contraindications for CPET and/or inability to pedal on a cycle ergometer
Pregnant or nursing
Currently (within 30 days prior to RHC) taking specific 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437878

Locations

United States, California
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90502
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
France
Hopital d'adultes de Brabois
Vandoeuvre-lès-Nancy, France, 54500
Spain
Hospital Clinic i Provincial
Barcelona, Spain, 08036

Sponsors and Collaborators

Actelion

Investigators

Study Director:

Frederic Bodin, MD

Actelion

More Information

No publications provided

Responsible Party:	Actelion
ClinicalTrials.gov Identifier:	NCT01437878 History of Changes
Other Study ID Numbers:	AC-063B201
Study First Received:	September 20, 2011
Last Updated:	February 6, 2013
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Committee for the Protection of Personnes France: Conseil National de l'Ordre des Médecins Spain: Agencia Española de Medicamentos y Productos Sanitarios Spain: Comité Ético de Investigación Clínica

Keywords provided by Actelion:

PH
COPD

Additional relevant MeSH terms:

Hypertension
Hypertension, Pulmonary
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Vascular Diseases
Cardiovascular Diseases

Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013