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

NCT01437878 | Terminated Phase 2 Results

• 1 other identifier: AC-063B201
• Study Type: interventional
• Target: 2
• Locations: 3 countries
• Sites: 11

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension

Keywords

PH; COPD

Outcome Measures

Primary Outcomes (1)

• Change in Endurance Time

  Change from baseline to week 4 in endurance time during constant work rate exercise testing

  Baseline to week 4

Secondary Outcomes (17)

• Participants With Treatment-emergent Adverse Events

  Baseline up to 24 hours post-EOT, approximately 4 weeks

• Change in Systolic Pulmonary Arterial Pressure

  15 minutes

• Change in Diastolic Pulmonary Arterial Pressure

  15 minutes

• Change in Mean Pulmonary Arterial Pressure

  15 minutes

• Change in Mean Right Atrial Pressure

  15 minutes

Study Arms (2)

iloprost

EXPERIMENTAL

single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system

Drug: Iloprost

placebo

PLACEBO COMPARATOR

matching placebo using the power disc-6 with I-neb AAD system

Drug: Placebo

Interventions

Iloprost DRUG

5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks

Also known as: Ventavis

iloprost

Placebo DRUG

matching placebo

placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Actelion: lead

Study Sites (11)

Los Angeles Biomedical Research Institute

Torrance, California, 90502, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70112, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Hopital d'adultes de Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Hospital Clinic i Provincial

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Maziar Assadi Gehr
• Organization: Actelion Pharmaceutical Ltd

maziar.assadi-gehr@actelion.com

+41 61 565 5525

Study Officials

• Frederic Bodin, MD

  Actelion

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 21, 2011
• Study Start: March 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 20, 2015
• Results First Posted: January 6, 2015

Record last verified: 2015-10

Locations

ES (1); FR (1); US (9)