The purpose of this study is to evaluate the effect of tobramycin inhalation solution (TIS) once daily compared tot placebo in patients with non-CF bronchiectasis. The primary endpoint is a reduction of exacerbations of the disease during the treatment period. Next to this parameter the investigators expect to show a significant beneficial effect on lung function parameters, QoL, bacterial load of pathogens in sputum and tobramycin resistance.
See uploaded study protocol
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
58
North West Clinics
Alkmaar, North Holland, Netherlands
VU Medical Center
Amsterdam, Netherlands
Zuyderland Medisch Centrum
Heerlen, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
Number of exacerbations
Time frame: 13 months
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Canisius Ziekenhuis
Nijmegen, Netherlands
UMCU
Utrecht, Netherlands