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

ConditionsPulmnary HypertensionCOPDPulmonary Hypertension Secondary to Lung Disease and/or Hypoxia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Sao Paulo General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 40 years or older.

Established diagnosis of severe or very severe Chronic Obstructive Pulmonary Disease (COPD), corresponding to GOLD stage 3 or 4.

Mean Pulmonary Artery Pressure (mPAP) > 35 mmHg.

Pulmonary Vascular Resistance (PVR) > 5 Wood Units (WU).

Disqualifiers

History of hypersensitivity to iloprost or other prostacyclin analogs.

Pregnancy or breastfeeding.

Trial design

Design model

Single group

Treatments tested in this trial

  • Iloprost is a synthetic molecule with pharmacological action

    Drug

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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Inhaled Iloprost TreatmentExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline and 12 weeks

Secondary outcomes

1

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.

Time frame
Baseline and 12 weeks
2

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.

Time frame
Baseline and 12 weeks
3

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.

Time frame
Baseline and 12 weeks
4

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.

Time frame
Baseline and 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo General Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: