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Study of inhaled BX004 bacteriophage treatment for adults with cystic fibrosis who have chronic Pseudomonas aeruginosa lung infection

Verified siteInvestigational
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with Cystic Fibrosis who have ongoing lung infections caused by bacteria called Pseudomonas aeruginosa. The study will test a new inhaled treatment called BX004, which contains natural substances called bacteriophages that specifically target these bacteria. The treatment is given through a special breathing device called an eFlow Nebulizer System, which turns the medication into a fine mist that can be inhaled into the lungs.

The main goal of this research is to determine if BX004 can reduce the amount of Pseudomonas aeruginosa bacteria in the lungs of people with Cystic Fibrosis after 8 weeks of treatment. During the study, some participants will receive BX004 while others will receive a placebo through the nebulizer. Neither the participants nor their doctors will know which treatment they are receiving during the study.

The study will last for about 60 days, during which participants will need to inhale the study medication. Throughout the study, doctors will collect samples and monitor how well the treatment is working by checking lung function, quality of life, and watching for any side effects. The treatment being tested is designed to be used alongside standard medications that patients normally take for their Cystic Fibrosis.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase begins

    You will receive either BX004 or a placebo through inhalation using a nebulizer

    The treatment will continue for 8 weeks while maintaining your standard cystic fibrosis medications

  2. Step 2

    Regular monitoring during treatment

    Your lung function will be measured at scheduled visits

    You will need to provide sputum samples (either naturally produced or induced) during clinic visits

    Regular assessments will include vital signs, lung examination, blood tests, and breathing tests (spirometry)

    You will complete quality of life questionnaires about respiratory symptoms

  3. Step 3

    End of treatment evaluation

    After 8 weeks (Day 57), final measurements will be taken

    The main assessment will focus on changes in Pseudomonas aeruginosa bacteria levels in your sputum

    Your lung function will be compared to the start of the study

    Final quality of life assessments will be completed

  4. Step 4

    Safety monitoring

    Throughout the study, any side effects or new symptoms will be recorded

    Regular health checks will monitor your safety during the treatment period

Who can join the trial?

10 criteria

  • You must be diagnosed with cystic fibrosis and have an ongoing lung infection caused by Pseudomonas aeruginosa (a type of bacteria)
  • You must be 18 years or older
  • Your FEV1 (a breathing test that measures how much air you can exhale in one second) must be between 40-80% of what is expected for your age, height, and gender
  • Your lung condition must be stable (not experiencing a sudden worsening of symptoms)
  • You must either be:
    • Using inhaled antibiotics for Pseudomonas aeruginosa in cycles
    • Using continuous inhaled antibiotics
    • Not using any antibiotics
    • You must be able to provide sputum samples (mucus coughed up from your lungs) during study visits, either by:
      • Natural coughing
      • Induced coughing (with medical assistance)
      • Samples can be collected at home or clinic

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Pregnant or breastfeeding women
  • Active lung infection with bacteria other than Pseudomonas aeruginosa (a type of bacteria commonly found in cystic fibrosis patients)
  • Recent lung transplant (within the last 6 months)
  • Severe liver problems or abnormal liver function tests
  • History of allergic reactions to similar medications
  • Participation in other clinical trials within the past 30 days
  • Unable to produce sputum (mucus from the lungs) samples when requested
  • Current use of other experimental treatments
  • Severe lung function impairment (less than 30% of predicted normal function)
  • Active smoking or use of tobacco products
  • Inability to use a nebulizer (a device that turns liquid medicine into a mist for inhalation)
  • Significant kidney problems or abnormal kidney function
  • Acute illness or infection requiring hospitalization within the past 2 weeks
  • Mental conditions that could interfere with following study procedures
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Investigated drugs

BX004 is a bacteriophage treatment delivered through nebulization (inhaled as a mist). It is designed to target and kill Pseudomonas aeruginosa bacteria that cause chronic lung infections in people with cystic fibrosis. Bacteriophages are viruses that specifically attack bacteria while being harmless to human cells. This treatment aims to reduce the amount of harmful bacteria in the lungs of patients with cystic fibrosis.

What is already known about the treatment

BX004 - An investigational nebulized bacteriophage therapy being studied for the treatment of chronic Pseudomonas aeruginosa lung infections in patients with cystic fibrosis. This medication is administered through inhalation using a nebulizer, which converts the liquid medication into a fine mist that can be breathed directly into the lungs. BX004 works by using specially selected viruses (bacteriophages) that specifically target and eliminate Pseudomonas aeruginosa bacteria without harming human cells or beneficial bacteria. Currently in Phase 2b clinical trials, this innovative approach represents a potential alternative to conventional antibiotics, especially important for addressing antibiotic-resistant bacterial infections commonly found in cystic fibrosis patients.

Investigated diseases

Cystic Fibrosis - A genetic condition that affects the cells producing mucus, sweat, and digestive fluids, causing these secretions to become thick and sticky. The disease primarily impacts the lungs and digestive system, where the buildup of thick mucus can trap bacteria and lead to frequent lung infections. In the digestive system, the thick secretions can prevent the release of digestive enzymes from the pancreas, affecting proper nutrient absorption. The condition is present from birth and affects various body systems throughout life, with symptoms including persistent coughing, recurring chest infections, and difficulty gaining weight. People with cystic fibrosis may also experience increased salt content in their sweat and male infertility.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519856-94-00Protocol codeBMX-04-002Estimated enrolment63 patientsSponsorBiomx Ltd.

sourced from the EU Clinical Trials Register and site verification

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