Not Yet RecruitingNot Applicable

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

15 participantsStarted 2025-12-10

Plain-language 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.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline and 12 weeks

Trial details

NCT IDNCT07263958

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Caio JC Fernandes, PhD

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

View on ClinicalTrials.gov More Pulmnary Hypertension trials