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Ongoing Clinical Trials for Bronchiectasis

This article provides detailed information about 12 ongoing clinical trials investigating new treatments for bronchiectasis, a chronic lung condition where the airways become permanently widened and damaged. These trials are being conducted across multiple countries in Europe and are testing various medications including inhaled antibiotics, anti-inflammatory drugs, and immunoglobulin therapies aimed at reducing lung infections, improving symptoms, and enhancing quality of life for patients.

Clinical trial locations

Study Comparing Ciprofloxacin, Colistimethate Sodium, and Ceftazidime for Treating Early Airway Infection in Adults with Bronchiectasis

This French trial is investigating treatment options for adults who have recently developed an infection with Pseudomonas aeruginosa bacteria in their airways. The study focuses on finding the most effective way to eradicate this early infection before it becomes chronic.

Main inclusion criteria: Participants must be at least 18 years old with confirmed bronchiectasis shown on a CT scan. They must have had a positive test for Pseudomonas aeruginosa within the last 3 months, and either have never had this bacteria before or have been free from it for at least one year with negative test results.

Main exclusion criteria: People who do not have bronchiectasis, those outside the specified age range, and individuals who belong to vulnerable populations requiring special protection are not eligible.

Study focus: The trial compares two treatment approaches. The first combines oral ciprofloxacin for 14 days with inhaled colistimethate sodium for 3 months. The second uses intravenous antibiotics for 14 days along with the same 3-month course of inhaled colistimethate sodium. The goal is to determine which approach is more effective at clearing the infection after 6 months.

Investigational drugs: Ciprofloxacin is an oral antibiotic that works by preventing bacterial growth. Colistimethate sodium is inhaled directly into the lungs using a nebulizer and helps eradicate the airway infection. IV anti-PA beta-lactam antibiotics are given through an intravenous line to kill resistant bacteria.

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

This large international trial spanning 22 European countries is testing a new oral medication called BI 1291583 over an extended period of 76 weeks.

Main inclusion criteria: Adults aged 18-80 years with confirmed bronchiectasis on CT scan, ability to produce sputum samples, and a history of at least 2 lung infection episodes requiring antibiotics in the past 12 months, or 1 episode plus a high symptom score.

Main exclusion criteria: People under 18 or over 80, pregnant or breastfeeding women, those with active lung infections at screening, severe liver or kidney disease, current tuberculosis, recent major surgery, or inability to perform breathing tests.

Study focus: The primary goal is to evaluate whether BI 1291583 can reduce the frequency of pulmonary exacerbations compared to placebo. The study also measures changes in lung function and quality of life related to respiratory symptoms.

Investigational drug: BI 1291583 is taken as a 2.5 mg tablet once daily. It is being evaluated for its ability to reduce the number of times patients experience worsening of their symptoms.

Study on Inhaled Colistimethate Sodium for Adults with Bronchiectasis and New Asymptomatic Pseudomonas Aeruginosa Infection

This German trial focuses on treating patients who have a new Pseudomonas aeruginosa infection but are not yet experiencing symptoms from it.

Main inclusion criteria: Adults 18 years or older with CT-confirmed bronchiectasis and a new positive sputum culture for Pseudomonas aeruginosa not older than 12 weeks. Importantly, participants must not have new or worsening respiratory symptoms in the 2 months before the positive culture.

Main exclusion criteria: Those without a bronchiectasis diagnosis, people outside the age range, and members of vulnerable populations are excluded.

Study focus: The study evaluates whether inhaled ColiFin therapy can achieve negative sputum cultures for Pseudomonas aeruginosa 28 weeks after starting treatment, compared to standard care. Researchers will also monitor the rate of lung flare-ups and changes in quality of life.

Investigational drug: ColiFin is a nebulizer solution containing colistimethate sodium, an antibacterial agent that disrupts bacterial cell membranes. It is inhaled as a mist to reach the lungs directly.

Study on the Effects of 7% Hypertonic Saline Inhalation and ELTGOL Physiotherapy for Patients with Bronchiectasis

This Spanish trial combines inhalation therapy with a specific physiotherapy technique to help clear mucus from the lungs.

Main inclusion criteria: Men and women 18 years or older with high-resolution CT-confirmed bronchiectasis, no recent worsening of symptoms, production of at least 10ml of thick mucus daily, at least one flare-up in the past year, and lung function showing FEV1 of 30% or more.

Main exclusion criteria: People with lung conditions other than bronchiectasis, those outside the age range, vulnerable populations, and those not meeting specific health requirements.

Study focus: The trial compares three approaches over 12 months: 7% hypertonic saline inhalation once daily plus ELTGOL physiotherapy twice daily, isotonic saline inhalation once daily plus ELTGOL twice daily, and ELTGOL alone twice daily. The study measures changes in mucus characteristics, infection frequency, and quality of life.

Investigational treatments: 7% hypertonic saline is a concentrated saltwater solution that draws water into the airways to thin mucus. ELTGOL is a breathing exercise technique specifically designed to clear mucus from the lungs.

Study on the Effects of Ensifentrine for Patients with Non-Cystic Fibrosis Bronchiectasis

This trial conducted in Spain and Italy tests ensifentrine, a medication that works through a different mechanism than antibiotics.

Main inclusion criteria: Adults aged 18-85 with confirmed non-cystic fibrosis bronchiectasis, ability to provide sputum samples showing mucopurulent or purulent color, at least one pulmonary exacerbation requiring antibiotics in the past year, and ability to use a nebulizer and perform spirometry tests.

Main exclusion criteria: People with cystic fibrosis bronchiectasis, those outside the age range, inability to use a nebulizer or follow study procedures, other interfering medical conditions, pregnancy or breastfeeding, recent lung infections, or current participation in another trial.

Study focus: The study evaluates whether ensifentrine can reduce the number of pulmonary exacerbations compared to placebo. It is a double-blind trial where participants receive either ensifentrine or placebo twice daily through a nebulizer.

Investigational drug: Ensifentrine is an inhalation suspension delivered through a nebulizer. It works as a dual inhibitor of phosphodiesterase 3 and 4 enzymes, leading to bronchodilation and reduced airway inflammation.

Study of Nebulized Human Normal Immunoglobulin (CSL787) for Adults with Non-cystic Fibrosis Bronchiectasis to Find Best Dose and Test Safety

This multi-country trial tests a novel approach using inhaled immunoglobulin, a type of immune system protein.

Main inclusion criteria: Adults aged 18-85 with CT-confirmed non-cystic fibrosis bronchiectasis, lung function showing FEV1 greater than 35% of predicted and at least 1 liter, and either at least 2 chest infections requiring antibiotics in the past year or 1 infection plus a respiratory questionnaire score above 40.

Main exclusion criteria: Age below 18 or above 75, cystic fibrosis, current pregnancy or breastfeeding, known allergy to immunoglobulins, active lung infection, recent participation in another trial, severe allergic reactions to treatments, significant kidney or liver disease, current or recent smoking, inability to use a nebulizer, recent antibiotic use for respiratory infection, immunodeficiency, or recent major surgery.

Study focus: The study evaluates the optimal dose of CSL787 and its effectiveness in preventing disease flare-ups over 12 months. It monitors the time to first flare-up and tracks lung health and overall well-being.

Investigational drug: CSL787 is human normal immunoglobulin delivered through a nebulizer. These antibodies may help protect against lung infections and reduce airway inflammation by supporting the immune system.

Study on Inhaled Tobramycin and Colistimethate Sodium for Adults with Chronic Bronchial Infection in Bronchiectasis

This Spanish trial investigates whether long-term inhaled antibiotic treatment can help manage chronic bronchial infections.

Main inclusion criteria: Adults aged 20-90 with confirmed bronchiectasis, at least 2 positive sputum cultures for the same bacteria in the past year, current follow-up by the Multidisciplinary Bronchiectasis Unit, and willingness to participate regardless of other ongoing treatments such as inhaled corticosteroids or bronchodilators.

Main exclusion criteria: People without adult bronchiectasis, those outside the age range, and members of vulnerable populations.

Study focus: The trial examines whether inhaled antibiotics over 48 weeks can reduce bacterial levels in the lungs after patients receive targeted oral or intravenous treatment. The study measures changes in bacterial colony-forming units compared to placebo.

Investigational drugs: Tobramycin and colistimethate sodium are both inhaled antibiotics that target bacteria directly in the lungs, potentially reducing the bacterial burden more effectively than systemic antibiotics.

Study on the Safety and Tolerability of Nebulised Sodium Nitrite Formulations in Patients with Non-Cystic Fibrosis Bronchiectasis and Pseudomonas Aeruginosa

This trial conducted in Romania, Poland, and Bulgaria tests a completely different approach using sodium nitrite formulations.

Main inclusion criteria: Adults aged 18-75 with CT-confirmed bronchiectasis, confirmed high levels of Pseudomonas aeruginosa or other harmful bacteria (at least 100,000 CFU/mL), ability to produce sputum daily, ability to self-administer inhaler and nebulizer, and appropriate vaccination against influenza and pneumococcus.

Main exclusion criteria: Lung conditions other than non-cystic fibrosis bronchiectasis, lack of required bacterial infections, age outside the specified range, and membership in vulnerable populations.

Study focus: The primary goal is to evaluate the safety and tolerability of two formulations called RESP302 and RESP303, both containing sodium nitrite. The study monitors treatment-related side effects, changes in vital signs, and drug levels in the blood.

Investigational drugs: RESP302 and RESP303 are nebulized formulations of nitric oxide that have antimicrobial properties, potentially helping to reduce bacterial load in the lungs through a different mechanism than traditional antibiotics.

Study on Gremubamab for Patients with Bronchiectasis and Chronic Pseudomonas Aeruginosa Infection

This Spanish trial tests a monoclonal antibody treatment given intravenously to target chronic Pseudomonas aeruginosa infections.

Main inclusion criteria: Adults aged 18-85 with clinically diagnosed bronchiectasis confirmed by chest CT scan, previous detection of Pseudomonas aeruginosa at least once in the 24 months before the study, and a positive sputum sample at screening and within 35 days before randomization.

Main exclusion criteria: People without both bronchiectasis and chronic Pseudomonas aeruginosa infection, those outside the age range, and vulnerable populations.

Study focus: The trial evaluates whether Gremubamab can reduce the amount of Pseudomonas aeruginosa bacteria in sputum over 12 weeks compared to placebo. Follow-up assessments occur at various intervals up to 168 days to monitor bacterial burden and health indicators.

Investigational drug: Gremubamab is a monoclonal antibody administered through intravenous infusion. It works by targeting specific bacterial components to reduce bacterial presence in the lungs, potentially leading to fewer infections and improved lung function.

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

This large multi-country trial is a continuation study for patients who already participated in previous trials testing BI 1291583, allowing researchers to gather long-term safety data.

Main inclusion criteria: Patients who completed the treatment period in specific previous Phase II trials as planned. Both men and women can participate if they agree to use appropriate birth control methods. Written informed consent following Good Clinical Practice guidelines is required.

Main exclusion criteria: Patients with a history of bronchiectasis who experienced treatment-emergent adverse events during previous treatments, and those belonging to vulnerable populations.

Study focus: The study monitors long-term safety by observing side effects over up to 12 months. It also tracks the time to first pulmonary exacerbation and the frequency of these episodes. Participants take either 1 mg, 2.5 mg, or 5 mg of BI 1291583 once daily.

Investigational drug: BI 1291583 (also known as ClairleafTM) is an oral medication designed to reduce inflammation and improve lung function in patients. The long-term monitoring helps researchers understand its safety profile over extended use.

Summary

The 12 ongoing clinical trials for bronchiectasis represent a diverse range of therapeutic approaches aimed at improving outcomes for patients with this chronic lung condition. Several key observations emerge from this collection of studies.

Geographically, there is notable concentration of trials in Western and Southern European countries, with Spain, Germany, France, and Italy participating in the highest number of studies. Spain stands out with 9 trials, reflecting a particularly active research environment for bronchiectasis treatment. Many trials are multi-country studies, indicating strong international collaboration in researching this condition.

From a treatment perspective, the trials explore several distinct therapeutic strategies. The most prominent is BI 1291583, an oral medication being tested in three separate trials across multiple countries, including both initial efficacy studies and long-term safety evaluations. This suggests significant pharmaceutical interest in this compound as a potential disease-modifying treatment.

Inhaled therapies represent another major focus, with trials testing various antibiotics including colistimethate sodium, tobramycin, and novel formulations like sodium nitrite. These reflect the clinical need for treatments that can directly target airway infections while minimizing systemic side effects.

Biologics and immunological approaches are also being explored, including the monoclonal antibodies gremubamab and itepekimab, as well as nebulized immunoglobulin CSL787. These represent potentially innovative mechanisms for managing the inflammatory aspects of the disease.

Several trials specifically target Pseudomonas aeruginosa infection, one of the most problematic bacteria in bronchiectasis. This includes both early eradication attempts and management of chronic infections, highlighting the clinical importance of this pathogen.

The trials vary considerably in duration, from 12-week safety studies to 76-week efficacy trials, reflecting different stages of drug development and different research questions. Common outcome measures include pulmonary exacerbation rates, bacterial burden in sputum, lung function tests, and quality of life assessments.

Overall, these trials demonstrate active research efforts to address the multiple challenges of bronchiectasis management, including infection control, inflammation reduction, mucus clearance, and prevention of disease progression. The variety of approaches being tested offers hope that new treatment options may become available to improve care for people living with this condition.

Ongoing Clinical Trials on Bronchiectasis

  • 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

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