Bronchiectasis is characterized by abnormal widening of the airways and persistent sputum production, which often leads to repeated chest infections and reduced quality of life. Current international guidelines vary in their recommendations regarding the use of mucoactive agents due to a lack of consistent evidence on their effectiveness.
This trial included 288 adults with non–cystic fibrosis bronchiectasis who experienced frequent pulmonary flare-ups and produced daily sputum. All the participants across 20 clinical sites received standard care and were randomly assigned to receive either hypertonic saline alone, carbocisteine alone, a combination of both, or no mucoactive therapy at all.
The study compared outcomes between groups receiving hypertonic saline versus no hypertonic saline, and carbocisteine versus no carbocisteine. The primary endpoint was the number of fully qualified pulmonary exacerbations over a 52-week period. Secondary measures included health-related quality of life, time to next exacerbation, and safety outcomes.
The participants treated with hypertonic saline experienced a mean of 0.76 exacerbations per year, when compared to 0.98 among those not using hypertonic saline. Similarly, the individuals taking carbocisteine averaged 0.86 exacerbations versus 0.90 without it (P=0.81).
In terms of quality-of-life scores and time to next exacerbation, no meaningful improvements were observed in any treatment group. Safety outcomes were consistent across all arms of the study, with similar rates of adverse and serious adverse events, suggesting that while the drugs are generally safe, they do not offer substantial clinical benefit in preventing flare-ups.
The findings of this research suggest that neither hypertonic saline nor carbocisteine meaningfully reduced the frequency of pulmonary exacerbations over one year. Larger, multicenter trials are imperative to definitively assess the potential role of these agents in bronchiectasis management.
Source:
Bradley, J. M., O’Neill, B., McAuley, D. F., Chalmers, J. D., De Soyza, A., Hill, A. T., Carroll, M., Loebinger, M. R., Duckers, J., Clarke, M., McLeese, R. H., Ferguson, K., Jackson, A., Campbell, C., McDowell, C., Agus, A., Norrie, J., Copeland, F., Downey, D. G., … CLEAR Investigator Team. (2025). Hypertonic saline or carbocisteine in bronchiectasis. The New England Journal of Medicine, NEJMoa2510095. https://doi.org/10.1056/NEJMoa2510095
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