bronchiectasis MedDRA version: 21.0 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: ColiFin(R)
Product Name: ColiFin
Product Code: J01X B01
Pharmaceutical Form: Powder and solvent for nebuliser solution
Sponsors
Philipps University Marburg
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of ColiFin® therapy for 4 weeks compared to no therapy on sputum/airway culture negativity for PA 28 weeks after randomisation;Secondary Objective: • To evaluate the effect of ColiFin® therapy for 4 weeks compared to no treatment on change in PA bacterial density (colony forming units; CFUs) in sputum from baseline to Day 29 of treatment the frequency of (mild to moderate) pulmonary exacerbations (requiring antibiotic treatment) in 28 weeks after Randomisation the frequency of severe exacerbations (hospitalizations) in 28 weeks after Randomisation time to first pulmonary exacerbation (requiring antibiotic treatment) after start of treatment quality of life (QoL) measured by the St. George’s Respiatory Quenstionnaire (SGRQ) Respiratory Symptom Score (RSS) measured by the Quality of Life Questionnaire Bronchiectasis (QoL-B) overall QoL measured by the Quality of Life Questionnaire Bronchiectasis (QoL-B) • To evaluate the effect of ColiFin® therapy for 4 weeks compared to no treatment on change in ppFEV1 • To evaluate the change in antibiotic susceptibility in sputum bacteria over the 24 weeks follow up period ;Primary end point(s): The primary endpoint is the proportion of sputum/airway culture negativity (=3 consecutively negative sputum/airway cultures) for PA 28 weeks after randomisation;Timepoint(s) of evaluation of this end point: 28 weeks after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in PA colony forming units (CFUs) in sputum from baseline to Day 29 of treatment • Rate of pulmonary exacerbations in 28 weeks after randomisation • Rate of severe exacerbations (hospitalizations) in 28 weeks after randomisation • Time to first pulmonary exacerbation after start of treatment • Change from baseline in respiratory symptom domain of the SGRQ over the 24 weeks follow up period • Change from baseline in quality of life measured by SGRQ over the 24 weeks follow up period • Change from baseline in quality of life measured by QOL-B over the 24 weeks follow up period • Change from baseline on change in ppFEV1 over the 24 weeks follow up period • Change in antibiotic susceptibility in isolated sputum PA over the 24 weeks follow up period ;Timepoint(s) of evaluation of this end point: 28 weeks after randomisation | — |
Countries
Germany
Contacts
Public ContactKKS Marburg
Koordinierungszentrum für Klinische Studien (KKS) Marburg
Outcome results
None listed