Study on the Effectiveness and Safety of LTP001 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 study will test a new treatment called LTP001, which is taken as a hard capsule by mouth. The purpose of the study is to see how effective and safe LTP001 is compared to a placebo in people with IPF.

Participants in the study will be randomly assigned to receive either the LTP001 treatment or a placebo. The study will last for about 26 weeks, during which participants will take the assigned capsules regularly. Throughout the study, participants will have their lung function monitored to see if there are any changes in their breathing capacity. This will help researchers understand how well the treatment works and if there are any side effects.

The study aims to provide valuable information on the potential benefits of LTP001 for people living with Idiopathic Pulmonary Fibrosis. By comparing the effects of the treatment to a placebo, researchers hope to determine if LTP001 can improve lung function and overall health in patients with this challenging condition.

1 randomization

Upon joining the study, participants are randomly assigned to receive either the investigational product LTP001 or a placebo. This process is blinded, meaning neither the participant nor the investigator knows which treatment is being administered.

2 treatment administration

Participants will take the assigned treatment orally in the form of hard gelatin capsules. The dosage is either 1 mg or 5 mg, depending on the specific treatment group assigned.

The treatment period lasts for 26 weeks, during which participants will continue taking the capsules as directed.

3 monitoring and assessments

Throughout the 26-week treatment period, participants will undergo regular assessments to monitor their health and the effects of the treatment.

These assessments include measuring changes in lung function, specifically the Forced Vital Capacity (FVC), which is a measure of lung volume.

Additional assessments may include physical examinations, laboratory tests, electrocardiograms (ECGs), and monitoring of vital signs.

4 end of treatment evaluation

At the end of the 26-week treatment period, participants will undergo a final evaluation to assess the overall impact of the treatment.

This evaluation will include a comparison of lung function from the start to the end of the treatment period, as well as any changes in symptoms or quality of life.

Who Can Join the Study?

  • You must provide written informed consent before any study assessments are done. This means you agree to participate after understanding the study details.
  • You need to be a male or female who is at least 40 years old.
  • You should have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) within the last 5 years. This diagnosis should follow specific guidelines and may involve special lung imaging tests or biopsies.
  • Your Forced Vital Capacity (FVC), which is a measure of lung function, should be at least 45% of what is expected for your age and size, with no significant worsening before starting the study.
  • Your Diffusing Capacity of the Lung for Carbon Monoxide (DLCO), which is another lung function test, should be at least 25% of what is expected, with no significant worsening before starting the study.
  • The study doctor should believe that you are unlikely to die from causes other than IPF in the next 2 years.
  • The study doctor should believe that you are unlikely to need a lung transplant during the study.
  • If you are taking medications called nintedanib or pirfenidone for IPF, you must have been on a stable dose for at least 8 weeks before starting the study.
  • You should be able to communicate well with the study doctor and understand and follow the study requirements.

Who Cannot Join the Study?

  • Patients who have a different lung condition other than Idiopathic Pulmonary Fibrosis (IPF) cannot participate. IPF is a disease that causes scarring in the lungs, making it hard to breathe.
  • Patients who are currently participating in another clinical trial are not eligible.
  • Patients who have had a recent lung infection or illness that affects their breathing may be excluded.
  • Patients who have a history of severe heart problems may not be able to join the study.
  • Patients who are pregnant or breastfeeding cannot participate in the trial.
  • Patients who have a known allergy to the study medication or its ingredients will be excluded.
  • Patients who are unable to follow the study procedures or attend the required visits may not be eligible.
  • Patients who have a history of drug or alcohol abuse may be excluded from the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany

Other Sites

Site Name City Country Status
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
Centrum Medycyny Oddechowej Mroz Sp. j. Bialystok Poland
Fakultni Nemocnice Brno Brno Czechia
St. Antonius Ziekenhuis Nieuwegein The Netherlands
University Hospital Olomouc Olomouc Czechia
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Fakultni Thomayerova nemocnice Prague Czechia
Fwvyphgbstzyzmh Cmxkrs Gxai Coswig Germany
Auywuvezl Uja Amsterdam The Netherlands
Kojkmxsf dhu Uezegurzzveh Mvapxcor Aff Munich Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
05.04.2023
Germany Germany
Not recruiting
05.04.2023
Poland Poland
Not recruiting
05.04.2023
The Netherlands The Netherlands
Not recruiting
05.04.2023

Trial locations

Investigated drugs:

Nintedanib is a medication used in the trial to help slow down the progression of idiopathic pulmonary fibrosis (IPF). It works by blocking certain enzymes that contribute to the scarring of lung tissue, which can help improve lung function and breathing in patients with IPF.

Pirfenidone is another treatment option in the study for patients with idiopathic pulmonary fibrosis. It helps reduce lung scarring and inflammation, potentially slowing the disease’s progression and preserving lung function.

Investigational Product A is a new treatment being tested in the trial for its effectiveness in treating idiopathic pulmonary fibrosis. The goal is to determine if it can improve lung function and slow disease progression compared to existing treatments.

Investigational Product B is another new therapy under investigation in the study. Researchers are evaluating its safety and ability to improve lung function in patients with idiopathic pulmonary fibrosis, aiming to offer a new treatment option for this condition.

Investigated diseases:

Idiopathic Pulmonary Fibrosis – Idiopathic pulmonary fibrosis is a chronic lung disease characterized by the thickening and scarring of lung tissue, leading to a progressive decline in lung function. The exact cause of this condition is unknown, which is why it is termed “idiopathic.” Over time, the scarring, or fibrosis, makes it increasingly difficult for the lungs to transfer oxygen into the bloodstream. Patients often experience symptoms such as persistent dry cough and shortness of breath, especially during physical activity. As the disease progresses, these symptoms can become more severe, impacting daily activities and quality of life. The progression of the disease varies among individuals, with some experiencing a rapid decline in lung function while others may have a slower progression.

Trial ID:
2023-508729-28-00
Protocol code:
CADPT09A12201
Trial Phase:
Therapeutic exploratory (Phase II)

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