subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways MedDRA version: 9.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Conditions
Interventions
Trade Name: Colistin CF
Product Name: Colistin CF
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Colistimethat-Natrium
Concentration unit: IU international unit(s)
Concentration type: eq
Sponsors
University of Jena
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has a confirmed diagnosis of cystic fibrosis based on: 3 positive sweat chloride tests and/or genetic characterisation 2. detection of P. aeruginosa in nasal lavage (culture) with chronic P. aeruginosa colonization of the lung (from day – 28) 3. informed consent of the patients or parents 4. Subject >= 6 years 5. Subject is able to comply with the inhalation procedures and nasal lavage procedures scheduled in the protocol. 6. Women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol (e.g. implants, combined oral contraceptives, injectables, some IUDs, sexual abstinence or vasectomised partner) Are the trial subjects under 18? yes 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. subject has a critical condition defined as: FEV1 < 30% and / or SaO2 < 93% without O2-substitution; need of O2-substitution 2. Subject had an ENT surgery within 3 months prior to study 3. Subject shows signs of nasal bleeding 4. Subject has an ear drum perforation 5. Subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy against pseudomonas aerug. 6. Subject is unlikely to comply with the procedures scheduled in the protocol 7. Subject has contraindications and known side effects to the medication 8. Subject is pregnant or breastfeeding 9. Subject participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study. 10. Systemic (oral or intravenous) antibiotic treatment against P.a. 14 days prior to the inclusion and during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid and in endoscopic swab at the ostium of the maxillary sinus;Secondary Objective: 1. drug safety of colistin nasal 2. changes of the Sino-nasal-outcome-test SNOT-20 adapt CF / patient`s diary 3. detection of P. aeruginosa in sputum / througt swab 4. genotyping of P. aeruginosa 5. changes of rhinoscopic findings (size of polyps, mucosa, secretions) 6. changes of rhinomanometric findings 7. cytology, cytokines in nasal lavage 8. incidence of rhinosinusitic and pulmonal exacerbations;Primary end point(s): Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid and in endoscopic swab at the ostium of the maxillary sinus | — |
Countries
Germany
Outcome results
None listed