CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Aerosolization of tobramycin (TOBI) with the PARI LC PLUS reusable nebulizer: which compressor to use? Comparison of the CR60 to the PortaNeb compressor.

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.

Keywords: Anti-Bacterial Agents; Bacterial Infections; Infection; Inhalation OR nebulised; pharmacological_intervention; Pseudomonas aeruginosa; Pseudomonas; Respiratory Tract Diseases; Respiratory Tract Infections; Tobramycin; non pharmacological intervention - devices OR physiotherapy; Aminoglycosides;