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: January 2, 2015
Last verified: January 2015
  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:
  • Participants With Treatment-emergent Adverse Events [ Time Frame: Baseline up to 24 hours post-EOT, approximately 4 weeks ] [ Designated as safety issue: Yes ]
    Treatment-emergent adverse events up to 24 hours post-end of treatment (EOT), approximately 4 weeks

  • Change in Systolic Pulmonary Arterial Pressure [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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.

  • Change in Diastolic Pulmonary Arterial Pressure [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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.

  • Change in Mean Pulmonary Arterial Pressure [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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.

  • Change in Mean Right Atrial Pressure [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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.

  • Change in Cardiac Output [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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.

  • Change in Right Ventricular Pressure [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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.

  • Change in Pulmonary Vascular Resistance [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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.

  • Change in End Tidal Partial Pressure of Carbon Dioxide [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.

  • Change in End Tidal Partial Pressure of Oxygen [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.

  • Change in Oxygen Uptake [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.

  • Change in Carbon Dioxide Output [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.

  • Change in Oxygen Uptake Per Heartbeat [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.

  • Change in Heart Rate [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Change from baseline to week 4. Heart rate was measured during incremental and constant work rate exercise testing.

  • Change in Arterial Oxygen Saturation as Indicated by Pulse Oximetry [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Change from baseline to week 4. Arterial oxygen was determined by pulse oximetry during incremental and constant work rate exercise testing.

  • Change in Tidal Volume [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Change from baseline to week 4. Tidal volume was measured during incremental and constant work rate exercise testing.

  • Change in Minute Ventilation [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Change from baseline to week 4. Minute ventilation was measured during incremental and constant work rate exercise testing.


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 Adaptive Aerosol Delivery (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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: December 12, 2014
Last Updated: January 2, 2015
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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cardiovascular Diseases
Respiratory Tract Diseases
Vascular Diseases
Iloprost
Cardiovascular Agents
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on March 26, 2015