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NCT Number: NCT07263958

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

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.

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Key information

Conditions

Pulmnary Hypertension COPD Cardiovascular Diseases Chronic Disease Disease Attributes Hypertension Hypertension, Pulmonary Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia Respiratory Tract Diseases Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iloprost is a synthetic molecule with pharmacological action

Drug

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

Primary outcomes

  1. Change from Baseline in Pulmonary Vascular Resistance (PVR) in Wood Units (WU)

    Time frame: Baseline and 12 weeks

    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.

Secondary outcomes

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

    Time frame: Baseline and 12 weeks

    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.

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

    Time frame: Baseline and 12 weeks

    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.

  3. Change in Risk of Mortality Stratification

    Time frame: Baseline and 12 weeks

    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.

  4. Change from Baseline in Mean Right Atrial Pressure (mRAP)

    Time frame: Baseline and 12 weeks

    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.

  5. Change from Baseline in Mean Pulmonary Artery Pressure (mPAP)

    Time frame: Baseline and 12 weeks

    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.

  6. Change from Baseline in Cardiac Index (CI)

    Time frame: Baseline and 12 weeks

    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.

  7. Change from Baseline in Mixed Venous Oxygen Saturation (SvO2)

    Time frame: Baseline and 12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caio JC Fernandes, PhD

CONTACT

[email protected]

+55 11 2661-1548

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Acronym: HOLLYWOOD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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