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Bi 1291583

Clinical trials are currently underway to investigate the potential of BI 1291583, a new drug being studied for its effects on bronchiectasis and cystic fibrosis bronchiectasis. These trials aim to assess the drug’s safety, tolerability, and effectiveness in treating these respiratory conditions. The studies involve various formulations and dosages of BI 1291583, as well as examining how the drug is processed in the body. This article summarizes the key findings from these ongoing clinical trials.

Table of Contents

What is BI 1291583?

BI 1291583 is a new investigational drug being developed to treat certain respiratory conditions[1]. It is currently undergoing clinical trials to evaluate its safety, effectiveness, and how it behaves in the human body. This medication is not yet approved for general use and is still in the research phase.

What Conditions Does BI 1291583 Treat?

Based on the clinical trials information, BI 1291583 is being studied for the treatment of two main conditions:

  • Bronchiectasis: This is a condition where the airways in the lungs become abnormally widened, leading to a build-up of excess mucus. This can cause repeated lung infections and breathing difficulties[2].
  • Cystic Fibrosis Bronchiectasis: This is a specific type of bronchiectasis that occurs in people with cystic fibrosis, a genetic disorder affecting the lungs and other organs[1].

How Does BI 1291583 Work?

While the exact mechanism of action is not explicitly stated in the provided information, we can infer some details based on the clinical trial data:

  • BI 1291583 appears to have an effect on neutrophil elastase (NE) activity in sputum. Neutrophil elastase is an enzyme released by white blood cells that can contribute to inflammation and tissue damage in the lungs. Reducing its activity may help alleviate symptoms in bronchiectasis[2].
  • The drug seems to target the underlying causes of pulmonary exacerbations (flare-ups) in bronchiectasis, potentially reducing their frequency and severity[2].
  • It may also improve lung function, as measured by tests like forced expiratory volume in one second (FEV1), which is the amount of air a person can forcefully exhale in one second[2].

Clinical Trials and Research

BI 1291583 is currently being studied in several clinical trials:

  • Safety and Tolerability Studies: These trials are testing how well the drug is tolerated by healthy volunteers and patients with bronchiectasis, and what side effects it might cause[3][4].
  • Pharmacokinetic Studies: These investigate how the drug is absorbed, distributed, metabolized, and eliminated by the body[5][6].
  • Efficacy Studies: Larger trials are examining whether BI 1291583 is effective in treating bronchiectasis, including how it affects exacerbations, quality of life, and lung function[2].
  • Long-term Studies: Some trials are looking at the long-term safety and efficacy of BI 1291583 in patients with bronchiectasis[7].

How is BI 1291583 Administered?

Based on the clinical trial information, BI 1291583 is administered as follows:

  • It is taken orally as a tablet[1].
  • The dosing is typically once daily[2].
  • Different doses are being tested to determine the most effective and safe amount[2].
  • Some studies are investigating how food affects the absorption of the drug[8].

Potential Side Effects

As BI 1291583 is still in clinical trials, a complete list of side effects is not yet available. The trials are carefully monitoring for any adverse events (unwanted effects) that may occur. These studies will help determine the safety profile of the drug[1][3].

Future Prospects

BI 1291583 shows promise as a potential new treatment for bronchiectasis and cystic fibrosis bronchiectasis. If the clinical trials demonstrate that it is safe and effective, it could provide a new option for patients with these conditions. However, it’s important to note that the drug is still in the research phase, and more studies are needed before it can be considered for approval by regulatory agencies[2][1].

Aspect Details
Drug Name BI 1291583
Conditions Studied Bronchiectasis, Cystic Fibrosis Bronchiectasis
Administration Oral tablet, once daily
Trial Durations 12 weeks to 1 year
Primary Outcomes Safety, tolerability, time to first pulmonary exacerbation
Secondary Outcomes Rate of pulmonary exacerbations, quality of life measures, lung function (FEV1), neutrophil elastase activity
Pharmacokinetic Measures AUC, Cmax, bioavailability
Study Designs Randomized, double-blind, placebo-controlled, parallel group

FAQ

  • What is BI 1291583? BI 1291583 is an investigational drug being studied for its potential to treat bronchiectasis and cystic fibrosis bronchiectasis. It is currently undergoing clinical trials to assess its safety, effectiveness, and how it is processed in the body.
  • What conditions is BI 1291583 being tested for? BI 1291583 is primarily being tested for bronchiectasis and cystic fibrosis bronchiectasis. These are respiratory conditions characterized by damaged airways and recurring lung infections.
  • How is BI 1291583 administered in the clinical trials? In most trials, BI 1291583 is administered as an oral tablet taken once daily. Some studies are testing different formulations and dosages to determine the most effective and safe way to give the medication.
  • What are the main goals of the BI 1291583 clinical trials? The main goals of the clinical trials include assessing the safety and tolerability of BI 1291583, determining its effectiveness in reducing pulmonary exacerbations, investigating how the drug is absorbed and processed by the body, and evaluating its impact on quality of life for patients with bronchiectasis.
  • How long do the clinical trials for BI 1291583 typically last? The duration of the clinical trials varies, but many last between 12 weeks to 1 year. Some trials, such as the Clairleaf™ study, may continue treatment for up to 1 year to assess long-term safety and efficacy.

Ongoing Clinical Trials on Bi 1291583

  • Study of BI 1291583 tablets taken once daily for 76 weeks in adults with bronchiectasis

    Recruiting

    3 1
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia Denmark +16

  • A study to test how BI 1291583 is broken down and removed from the body in healthy men

    Not recruiting

    1 1 1
    Investigated drugs:
    The Netherlands

  • Study on the Safety and Tolerance of BI 1291583 in Adults with Cystic Fibrosis Bronchiectasis

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Spain

  • Study on Long-Term Safety and Efficacy of BI 1291583 in Patients with Bronchiectasis

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia Denmark France Germany +8

Glossary

  • Bronchiectasis: A chronic lung condition where the airways (bronchi) become abnormally widened, leading to a build-up of excess mucus that makes the lungs more vulnerable to infection.
  • Cystic Fibrosis Bronchiectasis: A specific type of bronchiectasis that occurs in people with cystic fibrosis, a genetic disorder affecting the lungs and other organs.
  • Bioavailability: The proportion of a drug or substance which enters the circulation when introduced into the body and so is able to have an active effect.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics (PD): The study of the biochemical and physiological effects of drugs on the body, including their mechanisms of action and relationship between drug concentration and effect.
  • Pulmonary Exacerbation: A sudden worsening of respiratory symptoms in people with lung conditions, often requiring additional treatment such as antibiotics.
  • Neutrophil Elastase (NE): An enzyme released by white blood cells that can cause damage to lung tissue when present in high amounts, often used as a marker of inflammation in respiratory diseases.
  • Forced Expiratory Volume in One Second (FEV1): A measure of lung function that represents the volume of air a person can forcefully exhale in one second after taking a deep breath.
  • Quality of Life Questionnaire – Bronchiectasis (QOLB): A patient-reported outcome measure specifically designed to assess the quality of life in people with bronchiectasis.
  • St. George's Respiratory Questionnaire (SGRQ): A standardized questionnaire used to measure health-related quality of life in patients with respiratory diseases.

References

  1. https://clinicaltrials.gov/study/NCT05865886
  2. https://clinicaltrials.gov/study/NCT05238675
  3. https://clinicaltrials.gov/study/NCT04866160
  4. https://clinicaltrials.gov/study/NCT05183347
  5. https://clinicaltrials.gov/study/NCT06166992
  6. https://clinicaltrials.gov/study/NCT05833035
  7. https://clinicaltrials.gov/study/NCT05846230
  8. https://clinicaltrials.gov/study/NCT03837964