The purpose of this study is to assess pharmacokinetic and safety comparability of Bramitob® when administered for inhalation by using PARI eFlow® rapid electronic nebulizer vs PARI LC® PLUS nebulizer in Cystic Fibrosis Patients infected with Pseudomonas Aeruginosa
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days
(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days
University Hospital Brno Bohunice
Brno, Czechia
SMSI Institude of Cardiology
Chisinau, Moldova
University hospital with Health Center
Banská Bystrica, Slovakia
Fakultná nemocnica s poliklinikou Bratislava (FNsP)
Brastislava, Slovakia
Plasma tobramycin pharmacokinetic parameters (Cmax and AUC0-t) after twice daily inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer
Time frame: on day 28
Plasma tobramycin pharmacokinetic parameters (Cmax, tmax and AUC0-t) after inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer
Time frame: on day 1
Sputum tobramycin pharmacokinetic parameters (Cmax, tmax and AUC0-t) after inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer
Time frame: on day 1 and on day 28
Accumulation of tobramycin in plasma and sputum after repeated doses calculated as the ratio: AUC0-t DAY 28 / AUC0-t DAY 1 and Cmax DAY 28 / Cmax DAY 1
Time frame: day 1 - day 28
Safety assessed by adverse events, adverse drug reactions, incidence of bronchospasm, laboratory parameters, physical examination, body weight, vital signs results
Time frame: day1-day28
Number of patients with minimum plasma tobramycin levels Cmin > 2mcg/mL and maximum plasma tobramycin levels Cmax > 12 mcg/mL
Time frame: on day 28
Time necessary for the nebulization of the dose
Time frame: on day 1 and on day 28
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University Hospital of L. Pasteur, Pneumonology Department
Košice, Slovakia