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Efficiency of Pulmonary Administration of Tobramycin Solution for Inhalation in Cystic Fibrosis Using an Improved Drug Delivery System^*

David E. Geller, MD; Margaret Rosenfeld, MD, MPH; David A. Waltz, MD and Robert W. Wilmott, MD, FCCP; AeroDose TOBI Study Group

^* From The Nemours Children’s Clinic (Dr. Geller), Orlando, FL; University of Washington (Dr. Rosenfeld), Seattle, WA; Harvard University (Dr. Waltz), Boston, MA; and University of Cincinnati (Dr. Wilmott), Cincinnati, OH. Currently at St. Louis University, St. Louis, MO. The centers and principal investigators of the AeroDose TOBI Study Group are listed in the ^Appendix.

Correspondence to: David E. Geller, MD, The Nemours Children’s Clinic, 83 W Columbia St, Orlando, FL 32806-1101; e-mail: dgeller{at}nemours.org

Study objectives: To determine whether tobramycin solution for inhalation (TSI) can be administered safely and more efficiently with a new-generation aerosol device, the AeroDose 5.5 RP inhaler (Aerogen; Mountain View, CA) than with the approved PARI LC PLUS nebulizer (PARI Respiratory Equipment; Monterey, CA) with Pulmo-Aide compressor (DeVilbiss Corp; Somerset, PA). Second, we wanted to ascertain which AeroDose-delivered tobramycin dose is equivalent to the standard 300-mg dose administered with the PARI LC PLUS.

Design: Open-label, randomized, multicenter, single-dose, three-period, four-treatment, active- control, crossover trial.

Setting: Nine US cystic fibrosis (CF) centers.

Patients: Fifty-three patients 12 years of age with a confirmed diagnosis of CF, the ability to expectorate sputum, and FEV₁ of 40% of predicted.

Methods: Subjects inhaled three single doses of TSI at 1-week intervals, as follows: conventional control treatment, 300 mg via the PARI LC PLUS; and two of three experimental treatments, 30, 60, or 90 mg via the AeroDose. FEV₁ was measured before and after dosing. After each dose, sputum and serum samples were collected at various intervals for 8 h, and urine was collected for 24 h to estimate lung and systemic tobramycin delivery.

Results: There were no significant differences between treatments in the change in FEV₁ 30 min after dosing or in the frequency of adverse events. Sputum and serum levels of tobramycin produced by the AeroDose 90-mg dose treatment approximated those achieved with the PARI LC PLUS 300-mg dose treatment. Nebulization times using the AeroDose inhaler were < 50% those of the PARI LC PLUS.

Conclusions: Compared with the standard nebulizer, the AeroDose safely achieved an approximately threefold greater efficiency in the delivery of TSI to the lungs in less than half the time.

Key Words: antibiotics • cystic fibrosis • drug delivery systems • inhalation administration • nebulizers • pharmacokinetics • Pseudomonas aeruginosa • tobramycin

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