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Inhalation therapy in adult bronchiectasis patients with new asymptomatic Pseudomonas aeruginosa infection– an open-label, proof of concept - randomized controlled trial
EU CTIS ID: 2023-509277-22-00
What this study is testing
To evaluate the effect of ColiFin® therapy compared to SOC sputum/airway culture negativity for PA 28 weeks after randomization.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years at screening
- Bronchiectasis verified by chest CT scan
- New positive sputum culture for PA (not older than 12 weeks at screening)
- No recent onset of new respiratory symptoms or worsening of pre-existing respiratory symptoms (e.g. cough, sputum amount, sputum colour, sputum viscosity, haemoptysis, decreased exercise capacity, malaise, fatigue etc.) over the last 2 months before new positive PA sputum culture, as per investigator judgement
- Written informed consent
- Negative serum/urine pregnancy test in women of childbearing potential (WOCBP) at screening
You likely can't join if
- Bronchiectasis due to cystic fibrosis
- Pregnant women
- Breast feeding women
- strongly impaired renal function, GFR ≤ 30 ml/min
- Participation in any other interventional clinical trial
- Known prior infection with PA in the past 5 years before the new positive PA culture
See the full eligibility criteria
- Age ≥ 18 years at screening
- Bronchiectasis verified by chest CT scan
- New positive sputum culture for PA (not older than 12 weeks at screening)
- No recent onset of new respiratory symptoms or worsening of pre-existing respiratory symptoms (e.g. cough, sputum amount, sputum colour, sputum viscosity, haemoptysis, decreased exercise capacity, malaise, fatigue etc.) over the last 2 months before new positive PA sputum culture, as per investigator judgement
- Written informed consent
- Negative serum/urine pregnancy test in women of childbearing potential (WOCBP) at screening
- WOCBP must agree to maintain a highly effective method of contraception during study treatment and at least 4 weeks thereafter
- Male subjects have to use condom during treatment and until the end of relevant systemic exposure in the male subject, plus a further 90-day period and non-pregnant WOCBP partner have to use any contraception method additionally
- Bronchiectasis due to cystic fibrosis
- Pregnant women
- Breast feeding women
- strongly impaired renal function, GFR ≤ 30 ml/min
- Participation in any other interventional clinical trial
- Known prior infection with PA in the past 5 years before the new positive PA culture
- Treatment with pseudomonas-active antibiotics in the period between new PA positive sputum culture and baseline visit
- Planned pseudomonas-active antibiotic treatment during the time of study participation
- Any treatment with inhaled antibiotics or long-term pseudomonas-active treatment (≥3 months) in the past 5 years before screening
- Known intolerance to ColiFin® in prior medical history
- Hypersensitivity/Known intolerance to Colistimethate sodium, Colistin, polymyxin B or to other polymyxins
- Known diagnosis of myasthenia gravis or porphyria
- ppFEV1 < 30% (post-bronchodilator)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.