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

This study has been terminated.
(low recruitment)
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01437878
First received: September 20, 2011
Last updated: February 6, 2013
Last verified: February 2013
  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:


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:

  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 CPET and/or inability to pedal on a cycle ergometer
  4. Pregnant or nursing
  5. Currently (within 30 days prior to RHC) taking specific 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
  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 April 14, 2014