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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Iloprost
Placebo
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring PH, COPD

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Los Angeles Biomedical Research Institute
  • Mayo Clinic Jacksonville
  • Northwestern University
  • Ochsner Clinic Foundation
  • Massachusetts General Hospital
  • Cleveland Clinic
  • University of Oklahoma Health Sciences Center
  • Temple University Hospital
  • University of Pittsburgh Medical Center
  • Hopital d'adultes de Brabois
  • Hospital Clinic i Provincial

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

iloprost

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Participants With Treatment-emergent Adverse Events
Treatment-emergent adverse events up to 24 hours post-end of treatment (EOT), approximately 4 weeks
Change in Systolic Pulmonary Arterial Pressure
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
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
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
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
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
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
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
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
Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Change in Oxygen Uptake
Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Change in Carbon Dioxide Output
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
Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Change in Heart Rate
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
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
Change from baseline to week 4. Tidal volume was measured during incremental and constant work rate exercise testing.
Change in Minute Ventilation
Change from baseline to week 4. Minute ventilation was measured during incremental and constant work rate exercise testing.

Full Information

First Posted
September 20, 2011
Last Updated
October 16, 2015
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT01437878
Brief Title
Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
low recruitment
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension
Keywords
PH, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iloprost
Arm Type
Experimental
Arm Description
single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo using the power disc-6 with I-neb AAD system
Intervention Type
Drug
Intervention Name(s)
Iloprost
Other Intervention Name(s)
Ventavis
Intervention Description
5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
Change in Endurance Time
Description
Change from baseline to week 4 in endurance time during constant work rate exercise testing
Time Frame
Baseline to week 4
Secondary Outcome Measure Information:
Title
Participants With Treatment-emergent Adverse Events
Description
Treatment-emergent adverse events up to 24 hours post-end of treatment (EOT), approximately 4 weeks
Time Frame
Baseline up to 24 hours post-EOT, approximately 4 weeks
Title
Change in Systolic Pulmonary Arterial Pressure
Description
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.
Time Frame
15 minutes
Title
Change in Diastolic Pulmonary Arterial Pressure
Description
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.
Time Frame
15 minutes
Title
Change in Mean Pulmonary Arterial Pressure
Description
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.
Time Frame
15 minutes
Title
Change in Mean Right Atrial Pressure
Description
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.
Time Frame
15 minutes
Title
Change in Cardiac Output
Description
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.
Time Frame
15 minutes
Title
Change in Right Ventricular Pressure
Description
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.
Time Frame
15 minutes
Title
Change in Pulmonary Vascular Resistance
Description
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.
Time Frame
15 minutes
Title
Change in End Tidal Partial Pressure of Carbon Dioxide
Description
Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Time Frame
Baseline to week 4
Title
Change in End Tidal Partial Pressure of Oxygen
Description
Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Time Frame
Baseline to week 4
Title
Change in Oxygen Uptake
Description
Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Time Frame
Baseline to week 4
Title
Change in Carbon Dioxide Output
Description
Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Time Frame
Baseline to week 4
Title
Change in Oxygen Uptake Per Heartbeat
Description
Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
Time Frame
Baseline to week 4
Title
Change in Heart Rate
Description
Change from baseline to week 4. Heart rate was measured during incremental and constant work rate exercise testing.
Time Frame
Baseline to week 4
Title
Change in Arterial Oxygen Saturation as Indicated by Pulse Oximetry
Description
Change from baseline to week 4. Arterial oxygen was determined by pulse oximetry during incremental and constant work rate exercise testing.
Time Frame
Baseline to week 4
Title
Change in Tidal Volume
Description
Change from baseline to week 4. Tidal volume was measured during incremental and constant work rate exercise testing.
Time Frame
Baseline to week 4
Title
Change in Minute Ventilation
Description
Change from baseline to week 4. Minute ventilation was measured during incremental and constant work rate exercise testing.
Time Frame
Baseline to week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic Bodin, MD
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
Los Angeles Biomedical Research Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Hopital d'adultes de Brabois
City
Vandoeuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Hospital Clinic i Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

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

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