TY - JOUR
T1 - Inhaled mannitol improves lung function in cystic fibrosis
AU - Jaques, A
AU - Daviskas, E
AU - Turton, JA
AU - Mckay, Karin
AU - Cooper, P
AU - Stirling, RG
AU - Robertson, CF
AU - Bye, P.T.P.
AU - Lesouef, Peter
AU - Shadbolt, B
AU - Anderson, SD
AU - Charlton, B
PY - 2008
Y1 - 2008
N2 - Background: The airways in patients with cystic fibrosis (CF) are characterized by the accumulation of tenacious, dehydrated mucus that is a precursor for chronic infection, inflammation, and tissue destruction. The 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, and improves the clearance of mucus with the potential to improve lung function and respiratory health. To this end, this study examined the efficacy and safety of therapy with inhaled mannitol over a 2-week period.Methods; This was a randomized, double-blind, placebo-controlled, crossover study. Thirty-nine subjects with mild-to-moderate CF lung disease inhaled 420 mg of mannitol or placebo twice daily for 2 weeks. Following a 2-week washout period, subjects were entered in 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% confidence interval [CI], 3.3 to 10.7) compared to placebo 0.3% (95% CI, - 3.4 to 4.0; p <0.001). The absolute improvement with mannitol therapy was 121 mL (95% CI, 56.3 to 185.7), which was significantly more than that with placebo (0 mL; 95% CI, - 64.7 to 64.7). The forced expiratory flow in the middle half of the FVC increased by 15.5% (95% CI, - 6.5 to 24.6) compared to that with placebo (increase, 0.7%; 95% CI, - 8.3 to 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 a period of 2 weeks significantly improved lung function in patients with CF. Mannitol therapy was safe and well tolerated.Trial registration: Clinical Trials.gov Identifier: NCT00455130.
AB - Background: The airways in patients with cystic fibrosis (CF) are characterized by the accumulation of tenacious, dehydrated mucus that is a precursor for chronic infection, inflammation, and tissue destruction. The 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, and improves the clearance of mucus with the potential to improve lung function and respiratory health. To this end, this study examined the efficacy and safety of therapy with inhaled mannitol over a 2-week period.Methods; This was a randomized, double-blind, placebo-controlled, crossover study. Thirty-nine subjects with mild-to-moderate CF lung disease inhaled 420 mg of mannitol or placebo twice daily for 2 weeks. Following a 2-week washout period, subjects were entered in 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% confidence interval [CI], 3.3 to 10.7) compared to placebo 0.3% (95% CI, - 3.4 to 4.0; p <0.001). The absolute improvement with mannitol therapy was 121 mL (95% CI, 56.3 to 185.7), which was significantly more than that with placebo (0 mL; 95% CI, - 64.7 to 64.7). The forced expiratory flow in the middle half of the FVC increased by 15.5% (95% CI, - 6.5 to 24.6) compared to that with placebo (increase, 0.7%; 95% CI, - 8.3 to 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 a period of 2 weeks significantly improved lung function in patients with CF. Mannitol therapy was safe and well tolerated.Trial registration: Clinical Trials.gov Identifier: NCT00455130.
U2 - 10.1378/chest.07-2294
DO - 10.1378/chest.07-2294
M3 - Article
C2 - 18339790
VL - 133
SP - 1388
EP - 1396
JO - Chest: the cardiopulmonary and critical care journal
JF - Chest: the cardiopulmonary and critical care journal
SN - 0012-3692
IS - 6
ER -