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Inhaled Mannitol Improves Lung Function in Cystic Fibrosis

Institutions at which the work was performed: Children's Hospital at Westmead, Sydney, NSW Australia; Royal Prince Alfred Hospital, Sydney, NSW Australia; Royal Children's Hospital, Melbourne, VIC Australia; The Alfred Hospital, Melbourne, VIC, Australia; Princess Margaret Hospital for Children, Perth, WA Australia;Sir Charles Gairdner Hospital, Perth, WA Australia ; Green Lane Clinical Centre and Auckland City Hospital, Auckland, New Zealand

anna.jaques{at}pharmaxis.com.au

Abstract

BACKGROUND: The airways in cystic fibrosis (CF) are characterized by accumulation of tenacious, dehydrated mucus that is a precursor for chronic infection, inflammation and tissue destruction. Clearance of mucus is an integral component of daily therapy. Inhaled mannitol is an osmotic agent that increases the water content of the airway surface liquid (ASL) and improves clearance of mucus with the potential to improve lung function and respiratory health. To this end, this study examined the efficacy and safety of inhaled mannitol over a two week period.

METHODS: This was a randomized, double-blind, placebo-controlled, crossover study. Thirty nine subjects with mild to moderate CF lung disease inhaled 420mg mannitol or placebo twice daily for 2 weeks. Following a 2 week washout, subjects received the reciprocal treatment arm. Lung function, respiratory symptoms, quality of life and safety were assessed.

RESULTS: Mannitol treatment increased FEV₁ from baseline by a mean of 7.0% (95% CI 3.3, 10.7) compared to placebo 0.3% (95%CI -3.4, 4.0) p<0.001. Absolute improvement on mannitol was121 mL (95% CI 56.3, 185.7) which was significantly more than placebo, 0mL (95% CI -64.7, 64.7). FEF_25-75 increased by 15.5% (95% CI -6.5, 24.6) compared to placebo 0.7% (95% CI -8.3, 9.7) p<0.02. The safety profile of mannitol was adequate and no serious adverse events related to treatment were observed.

CONCLUSIONS: Inhaled mannitol treatment over two weeks significantly improved lung function in patients with CF. Mannitol was safe and well tolerated. (Clinical Trials.gov number, NCT00455130.)