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

This study has been terminated.
(low recruitment)
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01437878
First received: September 20, 2011
Last updated: January 2, 2015
Last verified: January 2015

September 20, 2011
January 2, 2015
March 2012
December 2012   (final data collection date for primary outcome measure)
Change in Endurance Time [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
Change from baseline to week 4 in endurance time during constant work rate exercise testing
Same as current
Complete list of historical versions of study NCT01437878 on ClinicalTrials.gov Archive Site
  • Participants With Treatment-emergent Adverse Events [ Time Frame: Baseline up to 24 hours post-EOT, approximately 4 weeks ] [ Designated as safety issue: Yes ]
    Treatment-emergent adverse events up to 24 hours post-end of treatment (EOT), approximately 4 weeks
  • Change in Systolic Pulmonary Arterial Pressure [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
  • Change in Oxygen Uptake [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
  • Change in Carbon Dioxide Output [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.
  • Change in Heart Rate [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Change from baseline to week 4. Tidal volume was measured during incremental and constant work rate exercise testing.
  • Change in Minute Ventilation [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Change from baseline to week 4. Minute ventilation was measured during incremental and constant work rate exercise testing.
treatment-emergent adverse events [ Time Frame: 24 hours post EOT ] [ Designated as safety issue: Yes ]
treatment-emergent adverse events up to 24 hours post-EOT
Not Provided
Not Provided
 
Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD)
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

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 additional analyzed.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Pulmonary Hypertension
  • Chronic Obstructive Pulmonary Disease
  • Drug: Iloprost
    5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks
    Other Name: Ventavis
  • Drug: Placebo
    matching placebo
    Other Name: Placebo
  • Experimental: iloprost
    single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system
    Intervention: Drug: Iloprost
  • Placebo Comparator: placebo
    matching placebo using the power disc-6 with I-neb AAD system
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Spain
 
NCT01437878
AC-063B201
No
Actelion
Actelion
Not Provided
Study Director: Frederic Bodin, MD Actelion
Actelion
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP