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

1

What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
University Hospital Jena KöR Jena Germany

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Virgen del Rocío University Hospital Sevilla Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Brno Brno Czechia
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Fondation Ildys Brest France
Uedcadhcodjptyjwnihxs Exwjf Aon Essen Germany
Ccwk Ugacemyueh Hnhoptfv Cork Ireland
Ssunueh Dcfcbfagu Poezuen Ijw Mphvgab Pjjeksncofaf W Gdksbtt Sdv z owfy Gdansk Poland
Newdeari Iunkmlonr Ov Tdrdndghxsxh Afq Lkjy Dcayatuu Warsaw Poland
Uliekgepix Htarjsxo Cxttubb Cologne Germany
Fpljmhzj ntvcfqohq Mjylb a Hqtwcgz Prague Czechia
Aqgkksybh Uey Amsterdam The Netherlands
Gurezg Uqdophjanc Fpoibcyaf Frankfurt Germany
Kajibdzh dao Uqfpkjrjzdem Mfgcoqqh Aph Munich Germany
Si Vsqujgqrfomrxga Ubksactoef Hgwdoqso Dublin Ireland
Hqqtftuy Vnbj dnolrmpy Barcelona Spain

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
22.07.2025
France France
Not recruiting
22.07.2025
Germany Germany
Not recruiting
22.07.2025
Ireland Ireland
Not recruiting
22.07.2025
Italy Italy
Not recruiting
22.07.2025
Poland Poland
Not recruiting
22.07.2025
Spain Spain
Not recruiting
22.07.2025
The Netherlands The Netherlands
Not recruiting
22.07.2025

Trial locations

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.

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 ID:
2024-519856-94-00
Protocol code:
BMX-04-002
Trial Phase:
Therapeutic exploratory (Phase II)

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