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

Actelion Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension

Treatments: Drug: Placebo; Drug: Iloprost

Study type: Interventional

Funder types: Industry

Identifiers

NCT01437878

AC-063B201

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 2 patient groups, including a placebo group

iloprost

Experimental group

Description:

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

Treatment:

Drug: Iloprost

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo