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primary studies published RCT

Pharmacokinetics and safety of tobramycin administered by the PARI eFlow rapid nebulizer in cystic fibrosis.

  • Year: 2009
  • Date: 2009
  • Author: Hubert D
Source

J Cyst Fibros. 2009 Sep;8(5):332-7. Epub 2009 Aug 3.

Study design (if review, criteria of inclusion for studies)

randomized, open-label, multicentre, two-period, crossover study

Participants

patients (n=25) with CF and chronic pulmonary pseudomonal infection

Interventions

Tobramycin 300 mg twice a day for 15 days via: 1. Pari LC plus® with compressor (conventional); 2. Pari eFlow rapid® (vibrating mesh).

Outcome measures

Adherence. Nebulisation time. Sputum tobramycin level. Serum tobramycin level. Adverse events. FEV1.

Main results

Nebulization times were significantly shorter for eFlow rapid versus LC PLUS on Day 1 (least squares mean estimate of the difference -10.5 min, 95% confidence intervals [CI] -12.6, -8.3, p<0.0001) and Day 15 (difference -7.7 min, 95% CI -9.0, -6.5, p<0.0001). Broadly comparable sputum/systemic exposure to tobramycin was observed and the incidence of adverse events was similar for both nebulizers.

Authors' conclusions

Use of the eFlow rapid nebulizer reduced TSI nebulization time. The systemic exposure to tobramycin appeared to be broadly similar in this exploratory study.

Related topics

Antibiotic treatment of early pseudomonas aeruginosa

Antibiotics for pulmonary exacerbations

Inhaled antibiotics in cystic fibrosis

MRSA eradication in CF

Prophylactic use of oral antistaphylococcal antibiotic

Scheduled antibiotics every 3-4 months / symptom-based treatment

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;