Neither hypertonic saline nor carbocisteine significantly reduced pulmonary exacerbations or improved quality of life in adults with noncystic fibrosis bronchiectasis, according to a recent study.
The open-label, randomized trial enrolled 288 participants across 20 hospitals in the United Kingdom. Eligible participants had frequent pulmonary exacerbations and daily sputum production. Participants were randomly assigned to receive hypertonic saline, carbocisteine, both agents, or standard care alone and were followed for 52 weeks. The primary endpoint was the number of adjudicated pulmonary exacerbations over the study period. Secondary endpoints included health-related quality-of-life scores, time to next exacerbation, antibiotic use, lung function, and safety outcomes.
The adjusted mean number of fully qualifying pulmonary exacerbations was 0.76 in participants who received hypertonic saline compared with 0.98 in those who did not. In participants who received carbocisteine, the mean number of exacerbations was 0.86 compared with 0.90 in those who did not. No treatment interaction was observed between hypertonic saline and carbocisteine.
Scores on the Quality of Life–Bronchiectasis questionnaire, the St. George’s Respiratory Questionnaire, and the EuroQol 5-Dimension 5-Level index were similar across groups. The time to next exacerbation, number of antibiotic days, and lung function measures showed no meaningful differences.
Adverse events occurred at similar rates in all groups. Among participants who received hypertonic saline, 17 serious adverse events occurred in 16 participants vs 22 events in 19 participants who did not receive the therapy. Serious adverse events occurred in 20 participants who received carbocisteine and 15 participants who did not. Gastrointestinal adverse events were more frequent in the carbocisteine group than in the no-carbocisteine group, though they did not persist and are a known side effect of the drug.
"The findings in our trial suggest that treatment with hypertonic saline or carbocisteine should be reconsidered in bronchiectasis," noted lead author Judy M. Bradley, PhD, of the Wellcome–Wolfson Institute for Experimental Medicine at Queen’s University Belfast in Belfast, United Kingdom, and colleagues. The "associated costs and treatment burdens are important to consider in the absence of benefits," they added.
The CLEAR trial was funded by the National Institute for Health and Care Research Health Technology Assessment Programme, with additional support from the Belfast Health and Social Care Trust Charitable Funds and PARI Pharma.
