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

HOLLYWOOD: Hemodynamic Evaluation and Management of Pulmonary Hypertension With Inhaled Iloprost in Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD; Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia; Pulmnary Hypertension
• Intervention / Treatment: Drug: Iloprost is a synthetic molecule with pharmacological action

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caio JC Fernandes, PhD; Phone Number: +55 11 2661-1548; Email: caio.cesar@hc.fm.usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Iloprost is a synthetic molecule with pharmacological action; Ventavis® is the commercial brand name for inhaled iloprost in Brazil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Pulmonary Vascular Resistance (PVR) in Wood Units (WU)	Change in Pulmonary Vascular Resistance (PVR) from baseline to week 12. PVR is a measure of the resistance to blood flow in the pulmonary circulation. It will be measured in Wood Units (WU) and assessed via invasive hemodynamic monitoring (Right Heart Catheterization). A lower PVR indicates improved pulmonary hemodynamics.	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in 6-Minute Walk Distance (6MWD)	Change in the distance in meteres a participant can walk on a hard, flat surface in 6 minutes. The 6MWD is a measure of exercise capacity.	Baseline and 12 weeks
Change From Baseline in Dyspnea as Measured by the Transitional Dyspnea Index (TDI) Score	The Transitional Dyspnea Index (TDI) measures changes in dyspnea from a baseline state. The baseline state is established using the Baseline Dyspnea Index (BDI). The TDI score is derived from three categories: functional impairment, magnitude of task, and magnitude of effort. The total score ranges from -9 (major deterioration) to +9 (major improvement). A higher positive score indicates a greater improvement in dyspnea.	Baseline and 12 weeks
Change in Risk of Mortality Stratification	Change in the patient's risk of mortality as assessed by the COMPERA 2.0 risk assessment model. This model stratifies patients into low, intermediate, or high risk based on a combination of clinical and hemodynamic variables.	Baseline and 12 weeks
Change from Baseline in Mean Right Atrial Pressure (mRAP)	Change in mean right atrial pressure (mRAP) from baseline to week 12. mRAP reflects right ventricular preload. It will be measured in millimeters of mercury (mmHg) via Right Heart Catheterization.	Baseline and 12 weeks
Change from Baseline in Mean Pulmonary Artery Pressure (mPAP)	Change in mean pulmonary artery pressure (mPAP) from baseline to week 12. mPAP is a key hemodynamic parameter for monitoring pulmonary hypertension. It will be measured in millimeters of mercury (mmHg) via Right Heart Catheterization.	Baseline and 12 weeks
Change from Baseline in Cardiac Index (CI)	Change in Cardiac Index (CI) from baseline to week 12. CI is a measure of cardiac performance relative to body size. It will be measured in liters per minute per square meter (L/min/m²) via Right Heart Catheterization. An increase indicates improved cardiac function.	Baseline and 12 weeks
Change from Baseline in Mixed Venous Oxygen Saturation (SvO2)	Change in mixed venous oxygen saturation (SvO2) from baseline to week 12. SvO2 reflects the balance between systemic oxygen delivery and consumption. It will be measured as a percentage (%) via Right Heart Catheterization.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: September 5, 2025
• First Submitted That Met QC Criteria: November 23, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Pulmonary Hypertension; Hemodynamics; iloprost; Chronic Obstructive Pulmonary Disease (COPD); Group 3 Pulmonary Hypertension; Prostacyclin Analog; PH-COPD
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Hypertension; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary
• Other Study ID Numbers: 85760525.5.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) that underlie the results reported in this article, including clinical, exercise, and hemodynamic data, will be made available to qualified researchers upon reasonable request. A data sharing proposal should be submitted to the corresponding author. The proposal will be reviewed by the study investigators for scientific merit and feasibility. To gain access, data requestors will need to sign a data access agreement and commit to using the data in a manner consistent with the original informed consent provided by the participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No