Not recruitingRare disease

Study on the Effects and Safety of Buloxibutid for Patients with Idiopathic Pulmonary Fibrosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a lung disease called Idiopathic Pulmonary Fibrosis (IPF). IPF is a condition where the lungs become scarred and breathing becomes difficult over time. The trial will test a new treatment called Buloxibutid, which is taken as a capsule. The purpose of the study is to evaluate how effective and safe Buloxibutid is for people with IPF compared to a placebo.

Participants in the study will be randomly assigned to receive either Buloxibutid or a placebo. The study will last for 52 weeks, during which participants will take the medication regularly. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The main focus will be on changes in lung function, specifically measuring how much air participants can exhale after taking a deep breath, known as Forced Vital Capacity (FVC).

The trial aims to gather information on how Buloxibutid affects the progression of IPF, including any changes in symptoms like cough and shortness of breath. It will also look at the overall health and quality of life of participants. By the end of the study, researchers hope to determine if Buloxibutid can help improve lung function and slow down the progression of IPF.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be randomly assigned to receive either buloxibutid or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.
The study involves taking oral capsules, which are hard capsules, for a duration of 52 weeks.
Step 2
Medication administration
Participants will take the assigned medication, either buloxibutid or placebo, as per the study protocol. The specific dosage and frequency will be provided by the study team.
The medication is taken orally, and participants are expected to adhere to the prescribed schedule for the entire 52-week period.
Step 3
Regular assessments
Throughout the study, participants will undergo regular assessments to monitor their health and the effects of the medication.
These assessments include measuring lung function, specifically the forced vital capacity (FVC), at various intervals: Weeks 4, 12, 24, 36, and 52.
Step 4
Symptom tracking
Participants will be asked to report any changes in symptoms such as cough, shortness of breath, and fatigue. This will be done using specific questionnaires at designated weeks.
The study will also track any respiratory-related hospitalizations and acute exacerbations of idiopathic pulmonary fibrosis (IPF).
Step 5
Safety monitoring
Safety is a priority, and participants will be monitored for any adverse events or side effects related to the medication.
Regular safety assessments will include laboratory tests, vital signs, and electrocardiograms (ECGs) to ensure participant well-being.
Step 6
Study completion
At the end of the 52-week period, participants will complete a final set of assessments to evaluate the overall impact of the treatment.
The study aims to determine the efficacy of buloxibutid in improving lung function and managing symptoms of IPF compared to the placebo.

Who can join the trial?

9 criteria

Must be **40 years or older** at the time of signing the consent form.
Must have been diagnosed with **idiopathic pulmonary fibrosis (IPF)** within the last 5 years, following specific medical guidelines.
Must have had a **high-resolution CT scan** in the last 36 months that confirms certain lung patterns related to IPF.
Must have a **forced vital capacity (FVC)** of at least 50% of what is predicted for their age and size. FVC is a measure of lung function.
Must have a **diffusing capacity of the lungs for carbon monoxide (DLCO)** of at least 35% of what is predicted. DLCO is another measure of lung function.
Must either be on a stable dose of approved IPF medication for at least 8 weeks or not be receiving any IPF treatment for specific reasons. Certain medications are not allowed during the trial.
Must have a **life expectancy** of at least 12 months and not be expected to need a lung transplant during the trial.
Women who can become pregnant must use highly effective **contraception**. Men with partners who can become pregnant must use a **male condom** and not donate sperm during the trial and for 2 weeks after.
Must provide **written informed consent** before starting any trial-related procedures.

Who cannot join the trial?

9 criteria

Patients with any other lung disease besides idiopathic pulmonary fibrosis cannot participate. Idiopathic pulmonary fibrosis is a condition where the lungs become scarred for an unknown reason.
Patients who have had a recent lung infection or illness that affects their breathing are not eligible.
Patients who have had a major surgery within the last 3 months cannot join the study.
Patients who are currently participating in another clinical trial are not allowed to participate.
Patients who have a history of severe heart problems are excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have a known allergy to the study medication or its ingredients are not eligible.
Patients who have a history of drug or alcohol abuse in the past year are excluded.
Patients who are unable to follow the study procedures or attend the required visits cannot participate.

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Verified sites

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Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Responsive
Essen, Germany
Thoraxklinik Heidelberg gGmbH
Responsive
Heidelberg, Germany

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Investigated drugs

Buloxibutid is a medication being studied for its potential to help people with idiopathic pulmonary fibrosis (IPF). This condition causes scarring of the lungs, making it difficult to breathe. The trial is testing how well buloxibutid works in improving lung function over a year. Participants in the study receive buloxibutid to see if it can help slow down the progression of the disease and improve their breathing capacity.

Buloxibutid

What is already known about the treatment

Buloxibutid – Buloxibutid is administered orally and is currently being studied in clinical trials for its potential use in treating idiopathic pulmonary fibrosis (IPF). This medication is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication for buloxibutid is to improve lung function in individuals with IPF, a condition characterized by progressive scarring of lung tissue. At the molecular level, buloxibutid is believed to work by modulating pathways involved in fibrosis, although the exact mechanism is still being researched. It falls under the pharmacological classification of antifibrotic agents.

Investigated diseases

Idiopathic Pulmonary Fibrosis – Idiopathic Pulmonary Fibrosis (IPF) is a chronic lung disease characterized by the progressive scarring of lung tissue. This scarring, or fibrosis, leads to a gradual decline in lung function, making it increasingly difficult for individuals to breathe. The exact cause of IPF is unknown, which is why it is termed "idiopathic." Over time, the thickened, stiff tissue can restrict the lungs' ability to expand, reducing oxygen intake. Symptoms often include a persistent dry cough, shortness of breath, and fatigue. As the disease progresses, these symptoms can become more severe, impacting daily activities and quality of life.