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Bi 1839100

BI 1839100 is a new drug being studied in clinical trials for its potential in treating pulmonary fibrosis and associated chronic cough. These trials aim to assess the safety, tolerability, and effectiveness of BI 1839100 in healthy individuals and patients with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). The studies range from initial safety assessments in healthy volunteers to more advanced trials evaluating the drug’s impact on cough frequency and lung function in patients with pulmonary fibrosis.

Table of Contents

What is BI 1839100?

BI 1839100 is a new drug currently being developed and tested for its potential to treat certain lung conditions and chronic cough. It is still in the early stages of research, known as clinical trials, where scientists are studying how well it works and how safe it is for patients[1][2].

What Conditions Does BI 1839100 Target?

The main conditions that BI 1839100 is being studied for are:

  • Idiopathic Pulmonary Fibrosis (IPF): This is a serious lung disease where the tissue in the lungs becomes scarred over time, making it difficult to breathe.
  • Progressive Pulmonary Fibrosis (PPF): This refers to various lung conditions where scarring in the lungs gets worse over time.
  • Chronic Cough: A persistent cough that lasts for a long time and is often associated with lung conditions like IPF and PPF.

Researchers are particularly interested in how BI 1839100 might help reduce coughing in people with these conditions, which can significantly impact their quality of life[3].

How Does BI 1839100 Work?

While the exact mechanism of how BI 1839100 works is not fully described in the available information, it appears to target the underlying causes of chronic cough in people with pulmonary fibrosis. The drug is being tested in both oral (taken by mouth) and intravenous (given through a vein) forms[2].

Current Clinical Trials

Several clinical trials are currently underway to study different aspects of BI 1839100:

  1. Safety and Tolerability Studies: These trials are testing how well people can tolerate different doses of the drug and what side effects might occur[1][4].
  2. Pharmacokinetic Studies: These look at how the drug moves through the body, including how it’s absorbed, distributed, and eliminated[2].
  3. Efficacy Studies: A larger trial is testing how well BI 1839100 works in reducing cough in people with IPF or PPF. This study is measuring things like cough frequency, cough severity, and quality of life[3].

Safety and Tolerability

The safety of BI 1839100 is a primary focus of the ongoing clinical trials. Researchers are carefully monitoring for any side effects or adverse reactions. So far, studies have included healthy volunteers to establish the drug’s safety profile before testing it in patients with lung conditions[5].

One study is even looking at how the drug affects skin sensitivity using a substance called allyl isothiocyanate (AITC), which is commonly found in mustard and wasabi[5].

Potential Drug Interactions

Researchers are also studying how BI 1839100 might interact with other medications. Specific drugs being tested for interactions include:

  • Midazolam: A sedative medication
  • Digoxin: A heart medication
  • Rosuvastatin: A cholesterol-lowering medication

These studies will help doctors understand if BI 1839100 can be safely taken with other common medications[4].

Future Prospects

While BI 1839100 is still in the early stages of development, it shows promise for potentially helping people with chronic cough related to pulmonary fibrosis. If the current trials show positive results, it could lead to further studies and potentially become a new treatment option for these challenging conditions[3].

It’s important to note that as a drug in development, BI 1839100 is not yet available for general use. Patients interested in this potential treatment should speak with their healthcare providers about the latest developments and possible clinical trial opportunities.

Aspect Details
Drug Name BI 1839100
Primary Conditions Studied Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis (PPF)
Main Study Objectives Safety, tolerability, pharmacokinetics, efficacy in reducing cough
Study Phases Phase I (healthy volunteers), Phase IIa/IIb (patients with IPF/PPF)
Key Outcome Measures 24-hour cough frequency, cough severity, lung function (FVC), quality of life
Study Designs Single and multiple rising dose, placebo-controlled, randomized
Special Assessments Drug-drug interactions, effect of food on drug absorption

FAQ

  • What is BI 1839100? BI 1839100 is a new drug being investigated for its potential to treat pulmonary fibrosis and reduce chronic cough associated with the condition. It is currently undergoing clinical trials to assess its safety, how the body processes it, and its effectiveness in managing symptoms.
  • What are the main goals of the BI 1839100 clinical trials? The main goals of the BI 1839100 clinical trials are to evaluate the drug's safety and tolerability, understand how it's processed in the body (pharmacokinetics), and assess its effectiveness in reducing cough frequency and improving lung function in patients with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF).
  • How is the effectiveness of BI 1839100 being measured in patients with pulmonary fibrosis? The effectiveness of BI 1839100 in patients with pulmonary fibrosis is being measured primarily by changes in 24-hour cough frequency. Other measures include changes in cough severity (using numerical rating scales and visual analog scales), forced vital capacity (FVC) to assess lung function, and quality of life questionnaires specific to living with pulmonary fibrosis.
  • Are there any side effects associated with BI 1839100? The clinical trials are designed to identify any potential side effects of BI 1839100. The studies include monitoring for treatment-emergent adverse events, which are any unfavorable and unintended signs, symptoms, or diseases that occur during the trial and may be related to the drug. Specific side effects are not mentioned in the provided information, as this is part of what the trials aim to determine.
  • Who can participate in these clinical trials? The clinical trials for BI 1839100 involve different groups of participants. Some studies are conducted with healthy male volunteers to assess initial safety and how the drug is processed in the body. Other trials involve adults aged 40 years and older with idiopathic pulmonary fibrosis (IPF) or 18 years and older with progressive pulmonary fibrosis (PPF) who have a chronic cough. Specific eligibility criteria may vary for each trial.

Ongoing Clinical Trials on Bi 1839100

  • Study on BI 1839100 for Reducing Cough in Patients with Idiopathic or Progressive Pulmonary Fibrosis

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +9

Glossary

  • Idiopathic Pulmonary Fibrosis (IPF): A chronic lung disease characterized by scarring (fibrosis) of the lungs for unknown reasons, leading to difficulty breathing and decreased lung function.
  • Progressive Pulmonary Fibrosis (PPF): A group of lung diseases where scarring of the lungs worsens over time, leading to declining lung function and increasing breathing difficulties.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Bioavailability: The proportion of a drug that enters the circulation when introduced into the body and is able to have an active effect.
  • Placebo: A substance that looks like the study drug but contains no active medication, used to compare the effects of the real drug.
  • Forced Vital Capacity (FVC): The total amount of air exhaled during a forced breath, used to assess lung function.
  • Cough Frequency: The number of times a person coughs over a specific period, often measured over 24 hours in these studies.
  • Visual Analogue Scale (VAS): A measurement tool used to subjectively score the severity of cough on a continuous scale from no cough to worst possible cough.
  • Numerical Rating Scale (NRS): A tool where patients rate their cough severity on a scale from 0 (no cough) to 10 (worst possible cough).
  • Leicester Cough Questionnaire (LCQ): A quality-of-life measure specific to cough, assessing its impact on physical, psychological, and social aspects of life.

References

  1. https://clinicaltrials.gov/study/NCT05934955
  2. https://clinicaltrials.gov/study/NCT06572111
  3. https://clinicaltrials.gov/study/NCT06360094
  4. https://clinicaltrials.gov/study/NCT05738291
  5. https://clinicaltrials.gov/study/NCT05354453