Pulmnary HypertensionHOLLYWOODNCT07263958
Hemodynamic Effects of Inhaled Iloprost in PH-COPD (HOLLYWOOD)
A study testing Iloprost is a synthetic molecule with pharmacological action in people with Pulmnary Hypertension and COPD, run by University of Sao Paulo General Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmnary Hypertension, COPD, Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia
- What is being tested?
- Iloprost is a synthetic molecule with pharmacological action
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2025to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of hypersensitivity to iloprost or other prostacyclin analogs.
- Pregnancy or breastfeeding.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
Read more
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
- Being tested
- Iloprost is a synthetic molecule with pharmacological action
- Keywords
- Pulmonary Hypertension, COPD, Hemodynamics, Prostacyclin Analog, iloprost, Chronic Obstructive Pulmonary Disease (COPD), Group 3 Pulmonary Hypertension, PH-COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iloprost is a synthetic molecule with pharmacological actionDrug
Ventavis® is the commercial brand name for inhaled iloprost in Brazil.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Iloprost is a synthetic molecule with pharmacological action |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start10 Dec 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmnary HypertensionStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caio Júlio César dos Santos Fernandes, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263958
- Sponsor's protocol ID
- 85760525.5.0000.0068
- Acronym
- HOLLYWOOD
- Status last verified
- Nov 2025
- First submitted
- 5 Sep 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOLLYWOOD: Hemodynamic Evaluation and Management of Pulmonary Hypertension With Inhaled Iloprost in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07263958
- Acronym / sponsor ID
- HOLLYWOOD / 85760525.5.0000.0068
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inhaled Iloprost Treatment | Experimental | Drug: Iloprost is a synthetic molecule with pharmacological actionParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (2 listed)
- History of hypersensitivity to iloprost or other prostacyclin analogs.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iloprost is a synthetic molecule with pharmacological actionVentavis® is the commercial brand name for inhaled iloprost in Brazil. | Drug | Inhaled Iloprost Treatment |
Primary outcome
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.
7 secondary outcomes
Change from Baseline in 6-Minute Walk Distance (6MWD)
Time frame: Baseline and 12 weeks
Change From Baseline in Dyspnea as Measured by the Transitional Dyspnea Index (TDI) Score
Time frame: Baseline and 12 weeks
Change in Risk of Mortality Stratification
Time frame: Baseline and 12 weeks
Change from Baseline in Mean Right Atrial Pressure (mRAP)
Time frame: Baseline and 12 weeks
Change from Baseline in Mean Pulmonary Artery Pressure (mPAP)
Time frame: Baseline and 12 weeks
Change from Baseline in Cardiac Index (CI)
Time frame: Baseline and 12 weeks
Change from Baseline in Mixed Venous Oxygen Saturation (SvO2)
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Iloprost is a synthetic molecule with pharmacological action in people with Pulmnary Hypertension and COPD, run by University of Sao Paulo General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caio JC Fernandes, PhD (+55 11 2661-1548, caio.cesar@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pulmonary Vascular Resistance (PVR) in Wood Units (WU) (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.