Inhaled mannitol in patients with cystic fibrosis: A randomised open-label dose response trial

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Abstract

Background: Cystic fibrosis (CF) is characterised by impaired mucociliary clearance (MCC), chronic inflammation and infection, and progressively deteriorating lung function. Inhaled mannitol (Bronchitol) has been shown to increase MCC and cough clearance and FEV1 in CF patients, contributing to better lung hygiene and consequently a slower decline in lung function. This study was designed to determine the dose relationship of mannitol treatment and improvement in FEV1 and FVC as well as safety. Methods: This was a randomised, open-label, crossover, dose response study. Following a 2-week treatment with mannitol 400mg b.i.d., 48 CF patients with a mean (SD) FEV1 % predicted of 64 (13.2), received a further 3 treatments with 40mg, 120mg or 240mg b.i.d. for 2weeks each, in random order. Results: The study demonstrated a dose dependent increase in FEV1 and FVC. The 400mg dose showed the greatest improvement and the 40mg dose had no discernible effect. The mean percent change in FEV1 was -1.57%, 3.61%, 3.87% and 8.75% respectively for the 40mg, 120mg, 240mg and 400mg treatments. There was a statistically significant change in FEV1 for 400mg compared to 40mg (p<0.0001) but the difference with 120mg and 240mg did not reach significance.The mean % change in FVC was -0.90, 1.74, 3.07 and 8.14, for the 40. mg, 120. mg, 240. mg and 400. mg treatment arms, with p = 0.0001, p = 0.0037 and p = 0.0304 respectively when compared to 400. mg. The highest tested dose of 400. mg had a similar safety profile to the other doses tested.The change in FEV1 and FVC by dose in the paediatric age group (<18years) was similar to the results in the adult population. Conclusion: Based on these results the 400. mg b.i.d. dose has been further studied in phase III trials. © 2010 European Cystic Fibrosis Society.

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Teper, A., Jaques, A., & Charlton, B. (2011). Inhaled mannitol in patients with cystic fibrosis: A randomised open-label dose response trial. Journal of Cystic Fibrosis, 10(1), 1–8. https://doi.org/10.1016/j.jcf.2010.08.020

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