Cystic fibrosis · Mucolytic therapy
A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis
| Design | Randomised, double-blind, controlled trial |
|---|---|
| Treatment | Inhaled 7% hypertonic saline twice daily, preceded by a bronchodilator |
| Control | Inhaled 0.9% saline |
| Population | 164 patients with cystic fibrosis aged 6 and over |
| Follow-up | 48 weeks |
| Primary endpoint | Rate of change in lung function over 48 weeks |
| Result | The slope of lung function decline did not differ between groups (p=0.79). However, the absolute difference in lung function averaged across all post-randomisation visits was significant (p=0.03), and the hypertonic saline group had significantly fewer exacerbations. |
| Secondary endpoints | Pulmonary exacerbations, quality of life, adverse events |
Hypertonic saline preceded by a bronchodilator is an inexpensive, safe, and effective additional therapy for patients with cystic fibrosis.
The trial authors, in the published abstract
The primary endpoint was negative and the trial changed practice anyway, on the strength of absolute lung function and exacerbations. Cheap, and for a long time the only alternative to dornase alfa. SIMPLIFY has since shown it can be stopped in stable patients on triple modulator therapy — and CLEAR found it does nothing at all in non-CF bronchiectasis.
Elkins MR, Robinson M, Rose BR, et al. A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis. N Engl J Med 2006 Jan 19;354(3):229-40.