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New treatment option for bronchiectasis: The world's first nebulized inhaled antibiotic for bronchiectasis approved
Published Time：
2022-10-20
The results of a Phase III clinical study on the treatment of bronchiectasis (BE) with Pseudomonas aeruginosa (PA) infection using inhaled tobramycin solution, jointly led by researcher Guan Weijie, assistant director of the Guangzhou Institute of Respiratory Health and the National Clinical Research Center for Respiratory Diseases, were published in the journal Chest. This study is currently the largest multicenter clinical study of BE in the world, and for the first time globally, it adopted a self-designed dual clinical efficacy endpoint (bacterial load + quality of life). "Has the achievement of clinical research findings been translated into application?"
The results of this Phase III multicenter clinical study showed that in patients with BE and PA infection, nebulized inhaled tobramycin significantly reduced sputum PA load, reduced 24-hour sputum volume, reduced purulent sputum score, significantly improved patients' quality of life, and had good safety.
On October 14, the National Medical Products Administration officially approved tobramycin inhalation solution, the world's first nebulized inhaled antibiotic for the treatment of bronchiectasis.
Bronchiectasis is a chronic respiratory disease characterized by permanent dilation of the bronchi, and airway remodeling lesions are difficult to significantly reverse. The incidence and prevalence of bronchiectasis are increasing globally, especially in China. Tobramycin is an aminoglycoside antibiotic with a concentration-dependent bactericidal mechanism. Traditional systemic administration has poor lung tissue penetration, low local drug concentration in the lungs, and a high risk of bacterial resistance. Due to the high systemic drug exposure, ototoxicity and nephrotoxicity are prone to occur, resulting in the inability of bronchiectasis patients to use the drug for a long time. Tobramycin inhalation solution changes the route of administration from intravenous injection to local inhalation, increasing the effective drug concentration in the lungs while avoiding systemic toxicity and significantly reducing the risk of drug resistance, making it suitable for long-term maintenance therapy. The Guangzhou Institute of Respiratory Health will continue to conduct a series of Phase IV clinical studies and real-world studies to benefit more bronchiectasis patients.
Source: National Clinical Research Center for Respiratory Diseases
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