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

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What is this study about?

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.

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.

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.

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.

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).

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Lungenfachklinik	Immenhausen	Germany
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH	Essen	Germany
Vivantes Netzwerk fuer Gesundheit GmbH	Berlin	Germany
Geniko Nosokomeio Thessalonikis George Papanikolaou	Thessaloniki	Greece
University General Hospital Of Heraklion	Heraklion	Greece
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.	Nowa Sol	Poland
Vitamed Galaj I Cichomski Sp. j.	Bydgoszcz	Poland
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi	Ancona	Italy
General University Hospital Of Larissa	Larissa	Greece
University General Hospital Of Ioannina	Ioannina	Greece
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
General University Hospital Of Patras	Patras	Greece
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Stadt Wien Wiener Gesundheitsverbund	Vienna	Austria
Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.	Lublin	Poland
Uniklinikum Salzburg	Salzburg	Austria
Cidzryswf Uqchgsiytijyar Sxdirfgma	Woluwe-Saint-Lambert	Belgium
Mfwpnlydz Isrqwmmpaw Clnkqstv Sngeogpc Ssq z opup	Warsaw	Poland
Lmfqs Gemyecz Hmznivno On Avtmlk	Athens	Greece
Asxxjhv Ohzgkzvcprm Ukjtrwlxsclkv Cqaquwqyoqpo Dwioj Sodwgr E Djscl Sldtjir Dq Tgrbor	Turin	Italy
Aliikhs Oqhctnagpad Pzkx Gcphpror Xwiyg	Bergamo	Italy
Jswbvlwj Kqieuk Ufzuxgjcft	Linz	Austria
Uwkgbjiqok Geazbhl Hxvzwmdy Aiultow	Athens	Greece

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	28.11.2024
Belgium	Not recruiting	28.11.2024
Germany	Not recruiting	28.11.2024
Greece	Not recruiting	28.11.2024
Italy	Not recruiting	28.11.2024
Poland	Not recruiting	28.11.2024

Trial locations

Investigated drugs:

Buloxibutid

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.

Investigated diseases:

Idiopathic pulmonary fibrosis

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.

Trial ID:

2023-509069-19-00

Protocol code:

VP-C21-011

Trial Phase:

Therapeutic exploratory (Phase II)

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

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