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: February 6, 2013
Last verified: February 2013

September 20, 2011
February 6, 2013
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
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
Same as current
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 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 CPET and/or inability to pedal on a cycle ergometer
  4. Pregnant or nursing
  5. Currently (within 30 days prior to RHC) taking specific 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
February 2013

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