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Hypertonic Saline or Carbocisteine in Bronchiectasis
Judy M Bradley1, Brenda O'Neill2, Daniel F McAuley1
1Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, United Kingdom.
The New England Journal of Medicine
|September 29, 2025
Summary
This study found that neither hypertonic saline nor carbocisteine significantly reduced pulmonary exacerbations in bronchiectasis patients over 52 weeks. Further large trials are needed to assess mucoactive agent effectiveness.
Area of Science:
- Respiratory Medicine
- Clinical Trials
- Pulmonology
Background:
- Bronchiectasis treatment guidelines lack consensus on mucoactive agent efficacy.
- Geographical variations exist in the clinical use of mucoactive agents for bronchiectasis.
- There is a need for large-scale trials to evaluate the safety and effectiveness of mucoactive agents in bronchiectasis management.
Purpose of the Study:
- To assess the effectiveness of hypertonic saline and carbocisteine in reducing pulmonary exacerbations in non-cystic fibrosis bronchiectasis.
- To evaluate the impact of these mucoactive agents on health-related quality of life and time to next exacerbation.
- To determine the safety profile of hypertonic saline and carbocisteine in this patient population.
Main Methods:
- An open-label, randomized, two-by-two factorial trial involving 20 UK sites.
- Participants with non-cystic fibrosis bronchiectasis experiencing frequent exacerbations and daily sputum production were enrolled.
- The study compared hypertonic saline, carbocisteine, their combination, and standard care alone, with a primary outcome of pulmonary exacerbations over 52 weeks.
Main Results:
- A total of 288 participants were randomized. No significant treatment interactions were observed.
- Hypertonic saline showed a non-significant reduction in exacerbations (0.76 vs. 0.98), with a P-value of 0.12.
- Carbocisteine also did not significantly reduce exacerbations (0.86 vs. 0.90), with a P-value of 0.81. Secondary outcomes and adverse events were similar across groups.
Conclusions:
- Neither hypertonic saline nor carbocisteine demonstrated a significant reduction in the mean incidence of pulmonary exacerbations over a 52-week period in patients with bronchiectasis.
- The findings suggest that current mucoactive agents may not be effective in reducing exacerbations in this patient group.
- Further research is warranted to clarify the role of mucoactive agents in bronchiectasis management.
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