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

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

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change in Endurance Time

Secondary Outcome

 Participants With Treatment-emergent Adverse Events

Condition

Chronic Obstructive Pulmonary Disease

Intervention

Iloprost

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

2

Start Date

March 2012

Completion Date

November 2012

Primary Completion Date

November 2012

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
      

Gender

All

Ages

40 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Frederic Bodin, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT01437878

Organization ID

AC-063B201


Responsible Party

Sponsor

Study Sponsor

Actelion


Study Sponsor

Frederic Bodin, MD, Study Director, Actelion


Verification Date

October 2015