How effective is tobramycin inhalation solution in treating cystic fibrosis

Tobramycin inhalation solution has significant efficacy in the treatment of cystic fibrosis ((CF)) and is used as a first-line treatment for early-stage Pseudomonas aeruginosa infection in the lungs ((Pa)), a recurrent lung infection in patients with cystic fibrosis.

To evaluate the long-term safety and efficacy of intermittent (28-day "on"/"off" cycles) inhaled 300 mg/4 ml (TNS4, Bramitob/Bethkis) over 56 weeks in CF patients aged ≥6 years with baseline forced expiratory volume in 1 second (FEV(1)) of 40-80% predicted.

In an 8-week open-label trial (core phase, NCT01111383), patients were initially randomized to compare TNS4 (N=159) with tobramycin inhalation solution 300 mg/5ml (TNS5, TOBI) (N=165). A subset of patients continued to receive TNS4 single-arm extension therapy through 48 weeks.

Results: During the core period (N=321), FEV(1) (% predicted) increased from baseline (absolute change) after a single treatment cycle for TNS4 (7.0%) and TNS5 (7.5%), and non-inferiority between treatments was achieved [difference between treatments -0.5 (95% CI: -2.6; 1.6)].

These improvements were maintained throughout the extension period (N=209), ranging between 5.1% (95% CI: 3.2; 6.9) and 8.1% (95% CI: 6.8; 9.4) compared to baseline across the study. Across 56 weeks, sputum count reductions ranged from 0.6 (95% CI: 0.2; 0.9) to 2.3 (95% CI: 2.0; 2.6) log10 CFU/g.

No significant safety issues were identified in either study phase, with a similar proportion of patients reporting adverse events in both treatment groups during the 8-week core phase [TNS4 (31.4%); TNS5 (28.0%)].

Conclusions: Overall, TNS4 demonstrated short-term clinical benefits similar to TNS5, which were maintained during long-term use of TNS4 and were associated with good tolerability.

Tobramycin inhalation solution increases the local effective drug concentration in the lungs while avoiding systemic toxicity. It also significantly reduces the risk of drug resistance and is suitable for long-term maintenance treatment. Tobramycin inhalation solution is an improved new drug developed by Health$. It is suitable for bronchiectasis in adults with pulmonary Pseudomonas aeruginosa infection, controlling infection and improving symptoms. It is the first inhaled antibiotic approved for marketing in China. It is recommended that patients take medication under the guidance of a doctor and receive symptomatic treatment.

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References

Mazurek H, Chiron R, Kucerova T, Geidel C, Bolbas K, Chuchalin A, Blanco-Aparicio M, Santoro D, Varoli G, Zibellini M, Cicirello HG, Antipkin YG. Long-term efficacy and safety of aerosolized tobramycin 300 mg/4 ml in cystic fibrosis. Pediatr Pulmonol. 2014 Nov;49(11):1076-89. doi: 10.1002/ppul.22989. Epub 2014 Jan 24. PMID: 24464974.