Status:
COMPLETED
Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF Patients
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Cystic Fibrosis With Pulmonary Manifestations
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Cystic fibrosis (CF), the most common autosomal recessive disorder in Western countries, is caused by mutations of the cystic fibrosis transmembrane conductance regulator molecule (CFTR) and affects a...
Eligibility Criteria
Inclusion
- Cystic Fibrosis is verified;
- Patient is 12 years or older;
- FEV1 is higher than 25% and lower than 100%;
- The patients' lung is colonised with P. aeruginosa chronically (≥6 months);
- P. aeruginosa must be sensitive for Tobramycin or Colistin;
- Pretreated with Colistin \>2 months;
- Last i.v. antibiotic treatment ≥2 weeks;
- Informed consent is given by patients/legal representatives
Exclusion
- Clinical deterioration is present (exacerbation symptoms);
- Last Tobramycin inhalation treatment ≤ 2 weeks;
- Renal dysfunction (creatinine \<1.5 fold of normal, glomerular filtration rate (GFR) \<80%) at baseline
- auditoria or vestibular dysfunction, hearing loss
- Intolerances against Tobramycin, Colistin or Polymyxin B
- Myasthenia gravis
- Porphyria
- Pregnancy and nursing
Key Trial Info
Start Date :
March 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2016
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03341741
Start Date
March 11 2014
End Date
November 25 2016
Last Update
November 14 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.