Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF Patients

• Status: Completed
• Trial end date: 2016-11-25
• Target enrollment: 0
• Participant gender: All

Summary

To assess whether the inhalative combination of Tobramycin/Colistin is more effective in reducing Pseudomonas colony forming units (CFUs) and improvement of lung function than Colistin in mono-therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Treatments: Colistin; Pharmaceutical Solutions; Tobramycin

Criteria

Inclusion Criteria:

1. Cystic Fibrosis is verified;

2. Patient is 12 years or older;

3. FEV1 is higher than 25% and lower than 100%;

4. The patients' lung is colonised with P. aeruginosa chronically (≥6 months);

5. P. aeruginosa must be sensitive for Tobramycin or Colistin;

6. Pretreated with Colistin >2 months;

7. Last i.v. antibiotic treatment ≥2 weeks;

8. Informed consent is given by patients/legal representatives

Exclusion Criteria:

1. Clinical deterioration is present (exacerbation symptoms);

2. Last Tobramycin inhalation treatment ≤ 2 weeks;

3. Renal dysfunction (creatinine <1.5 fold of normal, glomerular filtration rate (GFR) <80%) at baseline

4. auditoria or vestibular dysfunction, hearing loss

5. Intolerances against Tobramycin, Colistin or Polymyxin B

6. Myasthenia gravis

7. Porphyria

8. Pregnancy and nursing