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

NCT07263958 | Not Yet Recruiting

• 1 other identifier: 85760525.5.0000.0068
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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

Keywords

Pulmonary Hypertension; COPD; Hemodynamics; Prostacyclin Analog; iloprost; Chronic Obstructive Pulmonary Disease (COPD); Group 3 Pulmonary Hypertension; PH-COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from Baseline in 6-Minute Walk Distance (6MWD)

  Baseline and 12 weeks

• Change From Baseline in Dyspnea as Measured by the Transitional Dyspnea Index (TDI) Score

  Baseline and 12 weeks

• Change in Risk of Mortality Stratification

  Baseline and 12 weeks

• Change from Baseline in Mean Right Atrial Pressure (mRAP)

  Baseline and 12 weeks

• Change from Baseline in Mean Pulmonary Artery Pressure (mPAP)

  Baseline and 12 weeks

Study Arms (1)

Inhaled Iloprost Treatment

EXPERIMENTAL

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

Interventions

Iloprost is a synthetic molecule with pharmacological action DRUG

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

Inhaled Iloprost Treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Caio JC Fernandes, PhD

CONTACT

+55 11 2661-1548; caio.cesar@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Collaborating Physician, Pulmonary Circulation Group, Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: December 4, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share