What is the effectiveness of tobramycin inhaled solution?

Tobramycin inhalation solution generally refers to the ability to effectively reduce the density of Pseudomonas aeruginosa in sputum and is suitable for the treatment of Pseudomonas aeruginosa cystic fibrosis. For patients with bronchiectasis associated with Pseudomonas aeruginosa infection, tobramycin inhalation solution is an effective treatment option with acceptable safety.

Tobramycin Inhalation Solution, administered as a 300 mg nebulized aerosol for inhalation twice daily, is approved for the treatment of Pseudomonas aeruginosa infections in patients 6 years of age and older with cystic fibrosis.

Tobramycin inhalation solution for the treatment of adults with bronchiectasis and Pseudomonas aeruginosa infection

Research purpose: To evaluate the efficacy and safety of tobramycin aerosol inhalation solution (TIS) in the treatment of adults with bronchiectasis and Pseudomonas aeruginosa infection.

STUDY DESIGN AND METHODS: Eligible adults with bronchiectasis were recruited in a phase 3, 16-week, multicenter, randomized, double-blind, placebo-controlled trial. On the basis of routine care, patients inhaled tobramycin inhalation solution (300 mg/5 mL, twice daily) or normal saline (5 mL, twice daily) through a vibrating mesh nebulizer. Treatment consisted of two cycles, each consisting of 28 days of treatment and 28 days of non-treatment.

Study results: Tobramycin inhalation solution significantly reduced Pseudomonas aeruginosa density and resulted in greater improvements in quality of life bronchiectasis respiratory symptom scores compared with placebo. TIS resulted in significant reductions in 24-hour sputum volume and sputum-pus score on days 29, 57, and 85. On day 29, more patients in the tobramycin group had negative cultures for Pseudomonas aeruginosa than in the placebo group.

Efficacy of tobramycin inhalation solution in the treatment of bronchiectasis and Pseudomonas aeruginosa cystic fibrosis

In a placebo-controlled, double-blind, randomized study to evaluate the microbiological efficacy and safety of inhaled tobramycin in patients with bronchiectasis and Pseudomonas aeruginosa, patients were randomly assigned to receive tobramycin inhaled solution (n=37) or placebo (n=37) for 4 weeks followed by 2 weeks off treatment.

At week 4, Pseudomonas aeruginosa density decreased by an average of 4.54 log(10) colony-forming units (cfu)/g sputum in the tobramycin inhalation solution group compared with the placebo group (p < 0.01). At week 6, P. aeruginosa was eradicated in 35% of patients taking tobramycin inhalation solution but was detected in all placebo patients.

tobramycin inhalation solution

1. Usage: Using the handheld PARI LC PLUS equipped with a PARI Vios air compressor, you can reuse the nebulizer to inhale the tobramycin inhalation solution orally for about 15 minutes until the nebulizer output sputters for at least 1 minute.

2. Dosage: The recommended dose is 1 disposable ampoule (300mg/4 mL), administered by oral inhalation twice a day. The treatment cycle is 28 days, followed by 28 days of drug withdrawal. The interval between administration should be 12 hours, and at least 6 hours.

References:

1. Guan WJ, Xu JF, Luo H, Xu XX, Song YL, Ma WL, Liang ZA, Liu XD, Zhang GJ, Zhang XJ, Li RK, Zhu SY, Zhang YJ, Cai XJ, Wei LP, Tian DB, Zhao H, Chen PY, Qu JM, Zhong NS; TORNASOL Study Group. A Double-Blind Randomized Placebo-Controlled Phase 3 Trial of Tobramycin Inhalation Solution in Adults With Bronchiectasis With Pseudomonas aeruginosa Infection. Chest. 2023 Jan;163(1):64-76. doi: 10.1016/j.chest.2022.07.007. Epub 2022 Jul 19. PMID: 35863486.

2. Barker AF, Couch L, Fiel SB, Gotfried MH, Ilowite J, Meyer KC, O'Donnell A, Sahn SA, Smith LJ, Stewart JO, Abuan T, Tully H, Van Dalfsen J, Wells CD, Quan J. Tobramycin solution for inhalation reduces sputum Pseudomonas aeruginosa density in bronchiectasis. Am J Respir Crit Care Med. 2000 Aug;162(2 Pt 1):481-5. doi: 10.1164/ajrccm.162.2.9910086. PMID: 10934074.

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