Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF Patients
NCT03341741 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2017-11-14
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.
Conditions
- Cystic Fibrosis With Pulmonary Manifestations
Interventions
- DRUG
-
Tobramycin Powder
TOBI®Podhaler 2 x 112 mg daily for 2 x 28 days (on/off);
- DRUG
-
Colistin solution 2 x daily 1 Mega continuously
Sponsors & Collaborators
-
University Hospital Tuebingen
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-11
- Primary Completion
- 2015-12-19
- Completion
- 2016-11-25
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