Study design (if review, criteria of inclusion for studies)
open, randomized, crossover single dose pilot study
Participants
10 CF patients (>18 years)
Interventions
Tobramycin solution for inhalation (TSI): Tobramycin 300 mg via Pari LC plus with 1. CR60 compressor vs 2. Portaneb® compressor.
Outcome measures
Participant experience (questionnaire) Nebulisation time Tobramycin serum concentration Pharmacokinetics (Cmax) Pulmonary deposition (AUC0-6) Respiratory function Medication osmolality (ampoule and residual in nebuliser)
Main results
It was found that values of Cmax and AUC0-6 were higher with the CR60 than with the PortaNeb: 0.70 versus 0.54 mg/L, p = 0.005, and 2.54 versus 2.01 h.mg/L, p = 0.017, respectively. Tmax after use of the CR60 appeared earlier (0.64 vs. 0.85 h, p = 0.005). Transient airway narrowing was measured in three patients (2 x PN;1 x CR60) versus subjective chest tightness in seven patients (CR60 > PN). A shorter nebulization time for CR60 of 13.2 min compared to PN 16.1 min (p = 0.022) was observed, which was the main reason why patients preferred the CR60 (n = 7). No toxic serum levels were reached after inhalation of TSI.
Authors' conclusions
The CR60 compressor may seem advantageous based on a higher lung deposition and a shorter nebulization time, but a study in a large CF population to provide information on a possible higher risk of toxicity of TSI is called for.