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

NCT ID: NCT07263958

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-10
• Study Completion Date: 2026-12-20

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inhaled Iloprost Treatment

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.

Group Type: EXPERIMENTAL

Iloprost is a synthetic molecule with pharmacological action

Intervention Type: DRUG

Ventavis® is the commercial brand name for inhaled iloprost in Brazil.

Interventions

Iloprost is a synthetic molecule with pharmacological action

Ventavis® is the commercial brand name for inhaled iloprost in Brazil.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Caio Júlio César dos Santos Fernandes

Collaborating Physician, Pulmonary Circulation Group, Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Caio JC Fernandes, PhD

Role: CONTACT

caio.cesar@hc.fm.usp.br

+55 11 2661-1548

Other Identifiers

85760525.5.0000.0068

Identifier Type: -

Identifier Source: org_study_id