Hemodynamic Effects of Inhaled Iloprost in PH-COPD (HOLLYWOOD)

University of Sao Paulo General Hospital

Status: Not yet enrolling

Conditions: Pulmnary Hypertension; COPD; Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia

Treatments: Drug: Iloprost is a synthetic molecule with pharmacological action

Study type: Interventional

Funder types: Other

Identifiers

NCT07263958

85760525.5.0000.0068

Details and patient eligibility

About

Study Title: A Clinical Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension in Patients With Chronic Obstructive Pulmonary Disease (HOLLYWOOD)

The goal of this clinical study is to learn if the inhaled drug iloprost is effective and safe for treating pulmonary hypertension (PH) in adult patients who have severe or very severe Chronic Obstructive Pulmonary Disease (COPD).

The main questions it aims to answer are:

Does inhaled iloprost reduce the pressure and resistance in the lung's blood vessels (measured as Pulmonary Vascular Resistance - PVR)?

Does inhaled iloprost improve participants' ability to exercise, measured by how far they can walk in 6 minutes?

What are the side effects and medical problems that participants experience while taking inhaled iloprost?

Researchers will assess changes in participants' health by comparing measurements taken before they start taking inhaled iloprost to measurements taken after 12 weeks of treatment. There is no placebo group in this study.

Participants in this study will:

Use an inhaler to take iloprost 6 to 9 times every day for 12 weeks.

Visit the clinic for checkups at the beginning of the study and after the 12-week treatment period.

Undergo tests including an exercise capacity test (the 6-minute walk test) and heart pressure measurements (hemodynamic tests) before and after the treatment period.

Enrollment: 15 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 40 years or older.
• Established diagnosis of severe or very severe Chronic Obstructive Pulmonary Disease (COPD), corresponding to GOLD stage 3 or 4.
• Symptomatic Group 3 Pulmonary Hypertension (PH) confirmed by Right Heart Catheterization (RHC) with the following hemodynamic profile at rest:
• Mean Pulmonary Artery Pressure (mPAP) > 35 mmHg.
• Pulmonary Vascular Resistance (PVR) > 5 Wood Units (WU).
• Pulmonary Capillary Wedge Pressure (PCWP) ≤ 15 mmHg.
• Capable of providing written informed consent.

Exclusion criteria

• History of hypersensitivity to iloprost or other prostacyclin analogs.
• Pregnancy or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Inhaled Iloprost Treatment

Experimental group

Description:

Participants in this arm will receive inhaled iloprost for a 12-week period. The daily regimen consists of 6 to 9 inhalations, as tolerated. This is a single-group, pre-post study where clinical, exercise, and hemodynamic parameters are assessed at baseline (before treatment) and after 12 weeks to evaluate the efficacy and safety of the intervention.

Treatment:

Drug: Iloprost is a synthetic molecule with pharmacological action