Hemodynamic Effects of Inhaled Iloprost in PH-COPD (HOLLYWOOD)
NCT07263958 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2025-12-04
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
Interventions
- DRUG
-
Iloprost is a synthetic molecule with pharmacological action
Ventavis® is the commercial brand name for inhaled iloprost in Brazil.
Sponsors & Collaborators
-
University of Sao Paulo General Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-10
- Primary Completion
- 2026-06-30
- Completion
- 2026-12-20
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