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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01437878
• Other study ID #: AC-063B201
• Status: Terminated
• Phase: Phase 2
• First received: September 20, 2011
• Last updated: October 16, 2015
• Start date: March 2012
• Est. completion date: November 2012

Study information

• Verified date: October 2015
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaUnited States: Food and Drug AdministrationFrance: Conseil National de l'Ordre des MédecinsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United States: Institutional Review BoardSpain: Agencia Española de Medicamentos y Productos SanitariosFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypertension
• Hypertension, Pulmonary
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Hypertension

Intervention

Drug:
• Iloprost
5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks
• Placebo
matching placebo

Locations

Country	Name	City	State
France	Hopital d'adultes de Brabois	Vandoeuvre-lès-Nancy
Spain	Hospital Clinic i Provincial	Barcelona
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Los Angeles Biomedical Research Institute	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Endurance Time	Change from baseline to week 4 in endurance time during constant work rate exercise testing	Baseline to week 4	No
Secondary	Participants With Treatment-emergent Adverse Events	Treatment-emergent adverse events up to 24 hours post-end of treatment (EOT), approximately 4 weeks	Baseline up to 24 hours post-EOT, approximately 4 weeks	Yes
Secondary	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.	15 minutes	No
Secondary	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.	15 minutes	No
Secondary	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.	15 minutes	No
Secondary	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.	15 minutes	No
Secondary	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.	15 minutes	No
Secondary	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.	15 minutes	No
Secondary	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.	15 minutes	No
Secondary	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.	Baseline to week 4	No
Secondary	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.	Baseline to week 4	No
Secondary	Change in Oxygen Uptake	Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.	Baseline to week 4	No
Secondary	Change in Carbon Dioxide Output	Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.	Baseline to week 4	No
Secondary	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.	Baseline to week 4	No
Secondary	Change in Heart Rate	Change from baseline to week 4. Heart rate was measured during incremental and constant work rate exercise testing.	Baseline to week 4	No
Secondary	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.	Baseline to week 4	No
Secondary	Change in Tidal Volume	Change from baseline to week 4. Tidal volume was measured during incremental and constant work rate exercise testing.	Baseline to week 4	No
Secondary	Change in Minute Ventilation	Change from baseline to week 4. Minute ventilation was measured during incremental and constant work rate exercise testing.	Baseline to week 4	No