S106 A randomised double blind 13 week crossover trial of hypertonic saline (HTS) (6%) vs isotonic saline (ITS) (0.9%) in patients with bronchiectasis

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Abstract

Background

Hypertonic saline is a hyperosmolar agent which increases mucociliary clearance in CF but there is little data available on its effectiveness in bronchiectasis.

Aim

To determine the effectiveness of nebulised HTS (6%) in comparison to ITS (0.9%) on 24 h sputum production, lung function and patient related outcome measures in patients with stable bronchiectasis.

Design

Proof of concept double blind cross-over study.

Methods

Patients with clinical and CT diagnosis of bronchiectasis were randomised (double—blinded) to receive two consecutive 4-week treatments of twice daily nebulised HTS (6%) or ITS (0.9%) each masked with quinine sulphate; with a 2-week washout period between treatment cycles. The order of treatment was determined using concealed computerised randomised allocation performed by a statistician not involved in study conduct (EG).

Outcomes

24 h sputum volume/weight, lung function (FEV1), cough (Leicester Cough Questionnaire, LCQ) and quality of life (Quality of Life Questionnaire-Bronchiectasis, QOL-B), and adverse events.

Results

19 patients (9M: 10F; Mean (SD): 61 (11) yrs; FEV1, 57 (23) % predicted; daily sputum weight 17 (17) grams) were recruited into this study. 13 patients completed both arms of the study. A patient and co-ordinator questionnaire indicated that the study design and the use of quinine sulphate was successful in achieving double blinding and masking HTS/ITS. HTS had a small to large effect (effect sizes 0.01–0.14) on sputum and FEV1, LCQ, and QOL-B. The overall trend was a benefit from HTS compared to ITS. There was a significant improvement in the physical domain of the LCQ (−0.8 (0.9), p=0.01) and the respiratory symptoms domain of the QOL-B (−11.6 (17.7), p=0.03) in the HTS cycle compared to the ITS. There was no differences in adverse events between the cycles.

Conclusion

This study suggests that HTS may be effective in bronchiectasis. It provides data on study feasibility (study design and sample size) to justify a Phase 3 multicentre clinical trial to investigate the effectiveness of HTS in bronchiectasis.

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