Clinical trial NCT01437878: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Pulmonary Hypertension
Keywords: PH
COPD
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2011-09-21
Enrollment: 2
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Endurance Time
timeFrame: Baseline to week 4
Secondary outcomes:
measure: Participants With Treatment-emergent Adverse Events
timeFrame: Baseline up to 24 hours post-EOT, approximately 4 weeks
measure: Change in Systolic Pulmonary Arterial Pressure
timeFrame: 15 minutes
measure: Change in Diastolic Pulmonary Arterial Pressure
timeFrame: 15 minutes
measure: Change in Mean Pulmonary Arterial Pressure
timeFrame: 15 minutes
measure: Change in Mean Right Atrial Pressure
timeFrame: 15 minutes
measure: Change in Cardiac Output
timeFrame: 15 minutes
measure: Change in Right Ventricular Pressure
timeFrame: 15 minutes
measure: Change in Pulmonary Vascular Resistance
timeFrame: 15 minutes
measure: Change in End Tidal Partial Pressure of Carbon Dioxide
timeFrame: Baseline to week 4
measure: Change in End Tidal Partial Pressure of Oxygen
timeFrame: Baseline to week 4
measure: Change in Oxygen Uptake
timeFrame: Baseline to week 4
measure: Change in Carbon Dioxide Output
timeFrame: Baseline to week 4
measure: Change in Oxygen Uptake Per Heartbeat
timeFrame: Baseline to week 4
measure: Change in Heart Rate
timeFrame: Baseline to week 4
measure: Change in Arterial Oxygen Saturation as Indicated by Pulse Oximetry
timeFrame: Baseline to week 4
measure: Change in Tidal Volume
timeFrame: Baseline to week 4
measure: Change in Minute Ventilation
timeFrame: Baseline to week 4
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Vandoeuvre-lès-Nancy
country: France
facility: Hopital d'adultes de Brabois
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
Study officials:
affiliation: Actelion
name: Frederic Bodin, MD
role: STUDY_DIRECTOR
References: