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

Actelion11 sites in 3 countries2 target enrollmentMarch 2012

ConditionsChronic Obstructive Pulmonary Disease Pulmonary Hypertension

InterventionsPlacebo Iloprost

DrugsIloprost Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Actelion
Enrollment: 2
Locations: 11
Primary Endpoint: Change in Endurance Time
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

November 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Actelion

Responsible Party

Sponsor

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

Arms & Interventions

placebo

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

Intervention: Placebo

iloprost

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

Intervention: Iloprost

Outcomes

Primary Outcomes

Change in Endurance Time

Time Frame: Baseline to week 4

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

Secondary Outcomes

Change in Cardiac Output(15 minutes)
Change in End Tidal Partial Pressure of Oxygen(Baseline to week 4)
Change in Systolic Pulmonary Arterial Pressure(15 minutes)
Change in Mean Right Atrial Pressure(15 minutes)
Change in Right Ventricular Pressure(15 minutes)
Change in Pulmonary Vascular Resistance(15 minutes)
Change in Diastolic Pulmonary Arterial Pressure(15 minutes)
Change in End Tidal Partial Pressure of Carbon Dioxide(Baseline to week 4)
Change in Oxygen Uptake(Baseline to week 4)
Change in Carbon Dioxide Output(Baseline to week 4)
Change in Arterial Oxygen Saturation as Indicated by Pulse Oximetry(Baseline to week 4)
Change in Tidal Volume(Baseline to week 4)
Participants With Treatment-emergent Adverse Events(Baseline up to 24 hours post-EOT, approximately 4 weeks)
Change in Mean Pulmonary Arterial Pressure(15 minutes)
Change in Heart Rate(Baseline to week 4)
Change in Oxygen Uptake Per Heartbeat(Baseline to week 4)
Change in Minute Ventilation(Baseline to week 4)