Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH)

Hannover Medical School (MHH)

Status and phase: Terminated; Phase 4

Conditions: Hypertension

Treatments: Drug: Aerosolized iloprost; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00120380

COMBI

Details and patient eligibility

About

The purpose of this study is to test whether the addition of inhaled iloprost is safe and effective in patients with idiopathic pulmonary arterial hypertension who are already being treated with the endothelin receptor antagonist bosentan.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• IPAH
• > 3 months treatment with bosentan
• 6 minute walk distance 150 - 425 m

Exclusion criteria

• other forms of pulmonary hypertension
• severe comorbidities
• cotreatment with sildenafil or investigational drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Aerosolized Iloprost

Active Comparator group

Treatment:

Drug: Aerosolized iloprost

Bosentan monotherapy

Placebo Comparator group

Treatment:

Drug: Placebo