Inhalation therapy in adult bronchiectasis patients with new asymptomatic Pseudomonas aeruginosa infection– an open-label, proof of concept - randomized controlled trial

Phase 1

• Conditions: bronchiectasis; MedDRA version: 21.0Level: PTClassification code 10006445Term: BronchiectasisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-002335-33-DE
• Lead Sponsor: Philipps University Marburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-19
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1.Age = 18 years at screening.
2.Bronchiectasis verified by chest CT scan.
3.New positive sputum culture for PA (not older than 12 weeks at screening).

4. 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.
5.Written informed consent.
6.Negative serum/urine pregnancy test in women of childbearing potential (WOCBP) at screening,
7.WOCBP must agree to maintain a highly effective method of contraception during study treatment and at least 4 weeks thereafter.

Such methods include:
• combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
• progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
• intrauterine device (IUD)
• intrauterine hormone-releasing system (IUS)
• bilateral tubal occlusion
• vasectomised partner
• sexual abstinence

8. 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 66
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Bronchiectasis due to cystic fibrosis
2.Known prior infection with PA in the past 5 years before the new positive PA culture*
3.Treatment with pseudomonas-active antibiotics in the period between new PA positive sputum culture and baseline visit.
4.Planned pseudomonas-active antibiotic treatment during the time of study participation.
5. Any treatment with inhaled antibiotics or long-term pseudomonas-active treatment (=3 months) in the past 5 years before screening.
6. Known intolerance to ColiFin® in prior medical history.
7. Hypersensitivity/Known intolerance to Colistimethate sodium, Colistin, polymyxin B or to other polymyxins.
8. Known diagnosis of myasthenia gravis or porphyria
9. ppFEV1 < 30% (post-bronchodilator)
10. Pregnant women
11. Breast feeding women
12. strongly impaired renal function, GFR = 30 ml/min
13. Participation in any other interventional clinical trial

*Patients with a positive culture for PA from respiratory specimens within the past 5 years, but within a time frame of =3 years before new PA detection, who had at least 2 negative cultures for PA from respiratory specimens per year within these 3 years while not on pseudomonas-active treatment are also regarded as PA negative and can be included in the trial. Respiratory specimens include throat swab, sputum, tracheal/bronchial secretion and bronchial lavage fluid

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified